Researchers Study New Treatment for Triple-Negative Metastatic Breast Cancer

By Christine Cardellino, for LBBC; reviewed by Joyce O'Shaughnessy, MD

This phase III trial will study the effectiveness of the chemotherapy medicines gemcitabine and carboplatin with or without BSI-201, a PARP inhibitor

Trial Starts: 7/1/2009

Trial Ends: 6/30/2012

Sponsored By: BiPar Sciences

Researchers seek volunteers for a new phase III clinical trial that will study the effectiveness of the medicine BSI-201 added to chemotherapy in triple-negative metastatic breast cancers.

BSI-201 belongs to a new class of anticancer medicines known as PARP inhibitors. An estimated 420 women may enroll in the trial, which is open at 66 sites in the United States.

This trial is a follow-up to a phase II study presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2009. In that trial, researchers found that BSI-201, given in combination with chemotherapy, lengthened survival in women with triple-negative metastatic breast cancer compared to those who received chemotherapy alone. Learn more about the study presented at ASCO.

The new, larger study has the potential to change standard treatment for metastatic, triple-negative breast cancers. It is known officially as "A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer."

Can I Take Part?

To enroll in this study, you must have a diagnosis of metastatic, triple-negative breast cancer. Metastasis means the breast cancer has traveled beyond the breast to another part of the body, such as the liver or lungs. Triple-negative breast cancer tests negative for two hormones—estrogen and progesterone—and for extra copies of a gene, HER2 (human epidermal growth factor receptor 2).

To be eligible for this study, your doctor must be able to measure the size of the cancer. You may have had up to two prior chemotherapy regimens for metastatic breast cancer and chemotherapy for an early-stage breast cancer.

What Are the Medicines Under Study?

According to prior research, chemotherapy is the most effective treatment available for triple-negative disease, which occurs in 15 percent to 20 percent of breast cancers. This study uses the standard chemotherapy medicines gemcitabine (brand name: Gemzar) and carboplatin (brand name: Paraplatin), which are given together by vein (infusion).

The medicine under study is called BSI-201, a PARP inhibitor given by vein. PARP inhibitors work by blocking enzymes in cancer cells that help them to repair their own damaged DNA. When cancer cells cannot repair their DNA after treatment with chemotherapy (or radiation therapy, which was not included in this clinical trial), the cells eventually die.

What Treatments Will I Receive?

Participants in this clinical trial will be randomly divided into two groups, or arms. One group will receive treatment with gemcitabine/carboplatin alone (the standard therapy), while the other group will receive treatment with gemcitabine/carboplatin plus BSI-201 (the treatment under study). Researchers will compare the effectiveness of treatment in each arm of the trial.

This study is open-label, meaning both you and your doctor will know which treatment you are receiving.

What Are the Study Goals?

In this phase III trial, researchers will evaluate the study medicine’s effect on overall survival (time lived before death from breast cancer), progression-free survival (time lived without further growth of the cancer) and the degree to which tumors shrink in response to treatment (response rate).

Researchers also will study the safety and side effects of BSI-201 in combination with gemcitabine and carboplatin.

What Else Do I Need to Know?

PARP inhibitors such as BSI-201 have the potential to change the standard of care for triple-negative metastatic breast cancer. Early research into PARP inhibitors is promising, but these medicines must be given to more women in clinical trials before the treatment can earn approval from the U.S. Food and Drug Administration for widespread use.

By volunteering for this clinical trial, you may receive access to new therapies that already suggest potential benefits. You also may help to bring new treatment advances to other women diagnosed with triple-negative breast cancer. Ask your doctor about the risks and benefits of taking part in clinical research and if this particular trial is right for you.

To learn more about PARP inhibitors, read a recent article from Insight, LBBC's newsletter.

Read more about this clinical trial of BSI-201 for metastatic breast cancer.

For more information, contact: (650) 228-1880

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