Phase 3
N=736
A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00333775 ↗Enrolled (actual)
736
Serious AEs
42.2%
Results posted
Jan 2016
Primary outcome: Primary: Progression-free Survival — 8.0; 8.7; 8.8 Months — p=0.0318
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Docetaxel (Drug); Placebo to bevacizumab (Drug); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
8.0; 8.7; 8.8 | 0.0318 sig |
| SECONDARY Percentage of Participants With a Complete Response or a Partial Response |
1.0; 3.0; 1.0; 43.5; 52.2; 62.1 | — |
| SECONDARY Duration of Response |
6.4; 7.2; 7.0 | — |
| SECONDARY Time to Treatment Failure |
6.1; 7.0; 7.7 | 0.1105 |
| SECONDARY Overall Survival |
NA; NA; NA | 0.6962 |
Summary
This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.
Eligibility Criteria
Inclusion criteria
- Female patients ≥ 18 years of age.
- Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy.
- No adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion criteria
- Previous chemotherapy for metastatic or locally recurrent breast cancer.
- Radiotherapy for treatment of metastatic disease.
- Other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix.
- Spinal cord compression or brain metastases.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization.
- Inadequate bone marrow, liver, or renal function.
- Uncontrolled hypertension.
Data sourced from ClinicalTrials.gov (NCT00333775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.