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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metastatic Breast Cancer

In brief

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 facts

Study ID

NCT01663727

Run by

Hoffmann-La Roche

People needed

481

Starts

2012-08-27

Expected to finish

2017-11-21

Last updated by the study team

2019-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Wilshire Oncology Medical Group — Corona, California, United States
• Wilshire Oncology Medical Group — Glendora, California, United States
• Wilshire Oncology Medical Group — La Verne, California, United States
• Long Beach Memorial Medical Center; Oncology — Long Beach, California, United States
• Tenet Health System Desert Inc — Palm Springs, California, United States
• Wilshire Oncology Medical Group; Oncology — Pomona, California, United States
• Wilshire Oncology Medical Group — Rancho Cucamonga, California, United States
• Wilshire Oncology Medical Group — West Covina, California, United States
• Washington Hospital — Washington D.C., District of Columbia, United States
• Sylvester Comprehensive Cancer Center - Deerfield Beach; Sylvester Cancer Center — Deerfield Beach, Florida, United States
• Florida Cancer Specialists - Broadway — Fort Myers, Florida, United States
• BRCR Medical Center, Inc. — Plantation, Florida, United States
• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Northeast Georgia Cancer Care LLC — Athens, Georgia, United States
• Peachtree Hematology & Oncology Consultants, Pc — Atlanta, Georgia, United States
• Kaiser Foundation Hospital; Dr. Eron's Office — Honolulu, Hawaii, United States
• IU Cancer Pavilion — Indianapolis, Indiana, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
• Lahey Clinic Inc. - PARENT ACCOUNT — Burlington, Massachusetts, United States
• The Jones Clinic, PC — New Albany, Mississippi, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• Washington University; Center for Adv Medicine — St Louis, Missouri, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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