Protocol Title

A Double-Blind, Randomized Phase 2b Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo when Administered in Combination with Paclitaxel in Patients with Locally Recurrent or Metastatic Breast Cancer

Description

This study is being done to compare the effects of paclitaxel given with sorafenib to paclitaxel given with a placebo for breast cancer which has recurred locally or spread to other parts of the body. Paclitaxel 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 paclitaxel. Sorafenib may positively or negatively influence the effect of paclitaxel. Finding out what effect sorafenib might have is the purpose of this study. Participants will be randomly assigned to get either sorafenib with paclitaxel or placebo with paclitaxel; they will not get both treatments.

Objectives

To compare the time until disease progresses for participants treated with sorafenib plus paclitaxel versus placebo and paclitaxel.

To compare the number and duration of responses for participants treated with sorafenib plus paclitaxel versus placebo and paclitaxel.

To compare the length of survival for participants treated with sorafenib plus paclitaxel versus placebo and paclitaxel.

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 and 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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