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

Conditions

• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab [Avastin] — DRUG
  Intravenous repeating dose
• Paclitaxel — DRUG
  Intravenous repeating dose
• Placebo — DRUG
  Intravenous repeating dose

Study Details

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.

Key Dates

First listed

Aug 13, 2012

Start date

Aug 27, 2012

Status verified

Jan 2019

Primary completion

Nov 30, 2014

Completion

Nov 21, 2017

Study Design

Enrollment

481 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A
  Paclitaxel + Bevacizumab \[Avastin\]
• Experimental: B
  Paclitaxel + Placebo

Primary Outcome Measure

Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population [ Time Frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks) ]

Locations (66)

Find similar trials in Birmingham, AL

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