Protocol Title
A Double-Blind, Randomized Phase 2b 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
Description
This study is being done to compare the effects of gemcitabine given with sorafenib to gemcitabine given with a placebo for breast cancer which has recurred locally or spread to other parts of the body. Gemcitabine is a commonly used chemotherapy drug. Sorafenib is a new type of anti-cancer drug. A placebo does not contain any active medication and should not influence the effect of gemcitabine. Sorafenib may positively or negatively influence the effect of gemcitabine. Finding out what effect sorafenib might have is the purpose of this study. Participants will be randomly assigned to get either sorafenib with gemcitabine or placebo with gemcitabine; they will not get both treatments.
Objectives
To compare the time until disease progresses for participants treated with sorafenib plus gemcitabine versus placebo and gemcitabine.
To compare the number and duration of responses for participants treated with sorafenib plus gemcitabine versus placebo and gemcitabine.
To compare the length of survival for participants treated with sorafenib plus gemcitabine versus placebo and gemcitabine.
Eligibility
Patient is at least 18 years of age.
Patient has a histological diagnosis of locally recurrent or metastatic breast cancer and has disease that can be measured on their imaging studies (CT scan, MRI, bone scan).
Female patients of childbearing potential must have a negative pregnancy test. All participants must agree to use an accepted method of non-hormonal contraception.
Patient has adequate organ function and meets other guidelines for eligibility as specified by the protocol.
Contact
For the current eligibility status of and additional information about this clinical study, please contact Breastlink Clinical Research Group at 1-562-981-6101.
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