NCT00774241

Brief Summary

This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Typical duration for phase_4 breast-cancer

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

October 16, 2008

Last Update Submit

November 1, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate, median progression free survival, overall survival

    Event driven

Secondary Outcomes (1)

  • Adverse events

    Throughout study

Study Arms (1)

1

EXPERIMENTAL
Drug: bevacizumab [Avastin]Drug: docetaxel

Interventions

bevacizumab [Avastin]DRUG

15mg/kg iv every 3 weeks

1
docetaxelDRUG

75mg/m2 every 3 weeks for 18 weeks

1

Eligibility Criteria

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

You may qualify if:

  • male and female patients, \>=18 years of age;
  • stage IV, HER2 negative metastatic breast cancer;
  • candidate for taxane-based therapy;
  • ECOG performance status 0-2.

You may not qualify if:

  • prior chemotherapy for metastatic breast cancer;
  • concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
  • suspicion of CNS metastasis;
  • clinically significant cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BevacizumabDocetaxel

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

January 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11