NCT01277133

Brief Summary

This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic breast cancer. Patients will be followed for up to 12 months after progressive disease occurs.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

5.3 years

First QC Date

January 13, 2011

Last Update Submit

November 1, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation between the time from start of chemotherapy to the start of Avastin treatment with progression-free survival

    60 months

Secondary Outcomes (2)

  • Overall survival

    60 months

  • Safety: Incidence of adverse events

    60 months

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients with metastatic HER2 negative breast cancer. First-line treatment with Avastin

You may qualify if:

  • Adult patients, \>/=18 years of age
  • Previously untreated metastatic breast cancer
  • Scheduled to start 1st line chemotherapeutic treatment
  • ECOG performance status 0-1

You may not qualify if:

  • Any conditions included in contraindication list for Avastin
  • Prior chemotherapy for metastatic breast cancer
  • Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic malignancy completed \<6 months prior to treatment start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cluj-Napoca, 400015, Romania

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 14, 2011

Study Start

June 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

RO(1)