Researchers Test Safety and Effectiveness of New Advanced Breast Cancer Treatment

By Mary Alice Hartsock, LBBC Staff; Reviewed by: William J. Gradishar, MD, FACP

Phase II trial will compare paclitaxel plus sorafenib to paclitaxel alone in women with locally recurrent or metastatic breast cancer

Trial Starts: 6/1/2007

Trial Ends: 6/1/2014

Sponsored By: Northwestern University, Robert H. Lurie Cancer Center, National Cancer Institute

An international trial led by Northwestern University will compare the safety and effectiveness of paclitaxel (brand name: Taxol) plus sorafenib (brand name: Nexavar) as an initial treatment to paclitaxel alone in locally recurrent or advanced (metastatic) breast cancer.

This randomized Phase II trial will evaluate whether sorafenib, a medication approved to treat kidney cancer, also is useful in breast cancer when combined with paclitaxel. The primary goal of this study is to compare the groups’ measurements of progression-free survival, or time in which a cancer does not get worse during or after a treatment.

About Paclitaxel and Sorafenib

Paclitaxel is a taxane, a medication that works by slowing down or stopping the cell growth associated with some breast cancers. Paclitaxel is a "gold standard" chemotherapy treatment given intraveneously (by vein) for early and advanced breast cancer.

Sorafenib is an oral medicine called a kinase inhibitor that is used to stop the growth of tumor cells by blocking the enzymes needed for cell growth. It also works as an angiogenesis inhibitor, a class of medicines that prevent growth of blood vessels that are needed for tumor growth. Sorafenib is approved to treat advanced kidney cancer and liver cancer.

Earlier studies have suggested sorafenib may be a promising treatment for breast cancer. This trial will investigate whether adding sorafenib to paclitaxel will kill more tumor cells than would be killed with paclitaxel alone.

Structure of the Trial

The study will take place at various treatment centers throughout the United States and other parts of the world. The participants and their doctors will not know whether the women are receiving sorafenib. The women will be randomly assigned to one of two treatment arms:

Arm 1 participants will receive paclitaxel through an IV for one hour once weekly for three weeks. They also will take sorafenib as a pill twice daily on days 1-28.

Arm 2 participants will receive paclitaxel through an IV and will take a placebo, or sugar pill, twice each day on days 1-28.

Participants in both arms will repeat this treatment every 28 days as long as their disease does not progress.

The researchers will compare the arms for progression-free survival, overall survival (total time lived after treatment), the amount of time until the cancer grows, overall response rate and side effects. They will assess participants’ quality of life before the trial and at regular intervals throughout the trial.

Who Is Eligible?

Researchers are seeking approximately 220 women over age 18 who have been diagnosed with locally recurrent or metastatic breast cancer who:

• Do not have HER2 positive cancer
• Do not have breast cancer that has traveled to the brain or whose brain metastasis was treated at least three months ago
• Can swallow and hold down pills

You may need blood tests and a physical examination before beginning the study to confirm that you are eligible. If you are premenopausal, you may need a pregnancy test before enrolling.

Participants may not have a history of bleeding or healing problems, neuropathy, certain heart problems, uncontrolled high blood pressure, serious infection, HIV, hepatitis B or C or some other cancers.

Because this trial studies the effectiveness of sorafinib as an initial treatment, participants should not have undergone any treatment for locally recurrent or metastatic breast cancer. A period of 12 months must have passed since taxane therapy for early-stage breast cancer, and three weeks must have passed since any prior chemotherapy or hormonal therapy. Four weeks must have passed since surgery or open biopsy, and three weeks must have passed since radiation treatment.

For more information on eligibility, speak with your healthcare provider.

Learn more about this clinical trial.

For more information, contact: 800-4-CANCER

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