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

Roche

Status and phase: Completed; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Placebo; Drug: Bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01663727

GO25632

2011-005335-97 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 481 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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481 participants in 2 patient groups

A

Experimental group

Description:

Paclitaxel + Bevacizumab \[Avastin\]

Treatment:

Drug: Paclitaxel

Drug: Bevacizumab [Avastin]

B

Experimental group

Description:

Paclitaxel + Placebo

Treatment:

Drug: Paclitaxel

Drug: Placebo