NCT01094184

Brief Summary

This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 22, 2018

Completed
Last Updated

March 22, 2018

Status Verified

August 1, 2017

Enrollment Period

5.8 years

First QC Date

March 16, 2010

Results QC Date

December 19, 2016

Last Update Submit

August 25, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (110)

  • Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2

    FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 3

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 4

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 5

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 6

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 7

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 8

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score At Cycle 9

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 10

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 11

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 12

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 13

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 14

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 15

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 16

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 17

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 18

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 20

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 21

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 22

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 23

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 24

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 25

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 26

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 27

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 28

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 29

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 30

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 32

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 36

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 37

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 39

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 42

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 44

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at Cycle 46

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

  • Change From Baseline in FACT-B Score at End of Study

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

    Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

  • Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

  • Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 3

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 4

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 5

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 6

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 7

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 8

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 9

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 10

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 11

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 12

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 13

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 14

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 15

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 16

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 17

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 18

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 20

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 21

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 22

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 23

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 24

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 25

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 26

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 27

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 28

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 29

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 30

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 32

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 36

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 37

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 39

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 40

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 42

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 44

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at Cycle 46

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

  • Change From Baseline in EQ-5D-VAS Score at End of Study

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

Secondary Outcomes (5)

  • Percentage of Participants Who Died Due to Any Cause

    Baseline up to death (overall approximately 5 years and 9 months)

  • Overall Survival

    Baseline up to death (overall approximately 5 years and 9 months)

  • Percentage of Participants With Disease Progression

    Baseline up to disease progression (overall approximately 5 years and 9 months)

  • Time to Disease Progression

    Baseline up to disease progression (overall approximately 5 years and 9 months)

  • Percentage of Participants By Karnofsky Performance Status Scale Scores

    Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

Study Arms (2)

Bevacizumab 10 mg/kg Q2W

EXPERIMENTAL

Participants will receive bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

Drug: BevacizumabDrug: PaclitaxelDrug: Docetaxel

Bevacizumab 15 mg/kg Q3W

EXPERIMENTAL

Participants will receive bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

Drug: BevacizumabDrug: PaclitaxelDrug: Docetaxel

Interventions

BevacizumabDRUG

Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.

Also known as: Avastin
Bevacizumab 10 mg/kg Q2WBevacizumab 15 mg/kg Q3W
PaclitaxelDRUG

Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.

Bevacizumab 10 mg/kg Q2WBevacizumab 15 mg/kg Q3W
DocetaxelDRUG

Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.

Bevacizumab 10 mg/kg Q2WBevacizumab 15 mg/kg Q3W

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease
  • Participant who in the Investigator's opinion requires combination therapy for their disease
  • Life expectancy of greater than or equal to (\>/=)12 weeks

You may not qualify if:

  • Previous chemotherapy for metastatic breast cancer
  • Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
  • Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Bangor, LL57 2PD, United Kingdom

Location

Unknown Facility

Cottingham, HU16 5JG, United Kingdom

Location

Unknown Facility

Exeter, EX2 5DW, United Kingdom

Location

Unknown Facility

Grimsby, DN33 2BA, United Kingdom

Location

Unknown Facility

Harrogate, HG2 8AY, United Kingdom

Location

Unknown Facility

Plymouth, PL6 8DH, United Kingdom

Location

Unknown Facility

Portsmouth, PO6 3LY, United Kingdom

Location

Unknown Facility

Preston, PR2 9HT, United Kingdom

Location

Unknown Facility

Somerset, TA1 5DA, United Kingdom

Location

Unknown Facility

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BevacizumabPaclitaxelDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 26, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 22, 2018

Results First Posted

March 22, 2018

Record last verified: 2017-08

Locations

GB(10)