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

• Status: Completed
• Trial end date: 2017-11-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Paclitaxel

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