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
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Bevacizumab [Avastin]; Paclitaxel; Placebo
Intervention description: Intravenous repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Paclitaxel; Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 481.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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