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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




A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter 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 (USON GO25632)

Study Description:

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.

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

Locations:


Texas Oncology - Baylor Regional Medical Center at Plano
4708 Alliance Blvd., Suite 150
Plano , TX 75093

Texas Oncology - Baylor All Saints Medical Center at Fort Worth
1400 Eighth Avenue
Fort Worth , TX 76104

Texas Oncology - Baylor Medical Center at Garland
2300 Marie Curie Blvd.
Garland , TX 75042

Lead Principal Investigator:

Manish Gupta, MD (Plano and Garland); Sanjay Oommen, MD (Fort Worth)



This trial is no longer available for enrollment.

Last update: December 31, 2012
† Baylor Research Institute and Texas Oncology are not affiliated. Each reviews, approves, and conducts clinical trials independently. Their clinical trials are listed together on this website for the convenience of patients.