History & Overview Annual Report President's Pages Center News Community Affairs
Make a Gift Cycle for Survival Fred's Team Rock & Run on the River Yankees Universe Fund Thomas Blake Sr. Memorial Research Fund Donating Blood & Platelets Volunteering Thrift Shop Park Avenue Potluck Cookbook
Press Releases In the News Information for Journalists News@MSKCC
Manhattan New Jersey Long Island Westchester
Working at Memorial Sloan-Kettering Work Sites College Recruitment About Nursing Job Fairs & Career Days Job Search & Apply Online
Making an Appointment

A Phase IIb Study of Gemcitabine with or without Sorafenib in Women with Locally Advanced or Metastatic Breast Cancer That Has Progressed During or After Bevacizumab Therapy

[Protocol 07-131]

Full Title :
A DOUBLE-BLIND, RANDOMIZED PHASE IIB STUDY OF SORAFENIB COMPARED TO PLACEBO WHEN ADMINISTERED IN COMBINATION WITH CHEMOTHERAPY FOR PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER THAT HAS PROGRESSED DURING OR AFTER BEVACIZUMAB THERAPY
Purpose :

The purpose of this study is to compare the effects of gemcitabine given with or without sorafenib in women with locally advanced or metastatic breast cancer that has continued to grow despite treatment with bevacizumab. Gemcitabine is an anticancer drug approved for treating breast cancer that has returned or metastasized.

Sorafenib is a drug approved to treat a form of kidney cancer called renal cell carcinoma, and it is also being evaluated for the treatment of other types of cancer. It works by stopping a signal made by cancer cells, which they need to multiply and grow, and through inhibiting blood supply to cancer cells. It is a capsule that is taken orally (by mouth).

In this study, patients will be randomly assigned to receive gemcitabine plus sorafenib or a placebo (sugar pill).

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of locally advanced or metastatic breast cancer that has continued to grow despite treatment with bevacizumab. Patients with HER2-positive breast cancer may not participate.
  • At least 3 weeks must have passed since completion of prior therapy, and patients must have recovered from any side effects.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. Clifford Hudis at 646-888-5449.

Back to All Clinical Trials
Bookmark and SharePrintEmail This Page