Phase 3
Completed N=481
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01663727 ↗Enrolled (actual)
481
Serious AEs
23.6%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population — 69.4; 63.6 percentage of participants
Summary
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population |
69.4; 63.6 | — |
| PRIMARY Progression Free Survival (PFS) in ITT Population |
8.8; 11.0 | 0.0007 sig |
| PRIMARY Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population |
75.0; 70.8 | — |
| PRIMARY PFS in High Baseline Plasma VEGF-A ITT Population |
7.3; 9.6 | 0.0038 sig |
| SECONDARY Percentage of Participants Who Died - ITT Population |
64.9; 64.0 | — |
| SECONDARY Overall Survival (OS) - ITT Population |
25.8; 28.8 | 0.5877 |
| SECONDARY Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population |
74.2; 71.1 | — |
| SECONDARY OS - High Baseline Plasma VEGF-A ITT Population |
19.4; 22.8 | 0.2745 |
| SECONDARY Percentage of Participants With an Objective Response - ITT Population |
33.2; 54.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population |
32.8; 54.3 | 0.0017 sig |
| SECONDARY Duration of Response - ITT Population |
9.2; 9.5 | 0.2737 |
| SECONDARY Duration of Response - High Baseline Plasma VEGF-A ITT Population |
7.2; 8.1 | 0.1783 |
| SECONDARY Percentage of Participants Who Were Alive at 1 Year - ITT Population |
80.94; 82.47 | — |
| SECONDARY Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population |
69.27; 80.96 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- ECOG performance status of 0 or 1
- For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception
- For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization
Exclusion Criteria
Disease-Specific Exclusions:
- HER2-positive status
- Prior chemotherapy for locally recurrent or metastatic disease
- Prior hormonal therapy < 2 weeks prior to randomization
- Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization
- Investigational therapy within 28 days of randomization
General Medical Exclusions:
- Life expectancy of < 12 weeks
- Inadequate organ function
- Uncontrolled serious medical or psychiatric illness
- Active infection requiring intravenous (IV) antibiotics at screening
- Pregnancy or lactation
- History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
Data sourced from ClinicalTrials.gov (NCT01663727). 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. Informational only — not medical advice.