14-080 (TBCRC 030) - Cisplatin or Paclitaxel for Triple Negative Breast Cancer

STUDY BASICS

Have you been diagnosed with triple negative breast cancer? Are you a candidate for preoperative chemotherapy? If so, you may be able to participate in a research study to learn more about how triple negative breast cancer responds to preoperative treatment with cisplatin or paclitaxel, and if the use of a test called an assay can help predict response to preoperative treatment.

STUDY PURPOSE

Some women with breast cancer have chemotherapy treatment before surgery (called preoperative or neoadjuvant chemotherapy) in an effort to shrink their tumor(s) and potentially allow for less extensive surgery. The purpose of this study is to find out more about how triple-negative breast cancers respond to preoperative chemotherapy treatment with cisplatin or paclitaxel. Triple negative breast cancers are cancers that are negative for estrogen, progesterone, and HER-2 receptors. Researchers also hope to find out if a test called the Homologous Recombination Deficiency (HRD) assay can predict how tumors respond to preoperative chemotherapy with cisplatin or paclitaxel. The HRD assay measures changes in the tumor’s genes.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18 and up
• Diagnosed with triple negative breast cancer (negative for estrogen, progesterone, and HER-2 receptors)
• Considering receiving chemotherapy before surgery
• Have not had any prior chemotherapy or treatment for current breast cancer diagnosis

WHAT PARTICIPANTS CAN EXPECT

Total participation lasts about 16-18 weeks. An initial screening visit may include medical history questions, a physical exam, tumor size assessment, blood draws, pregnancy test, breast cancer biopsy, and fine needle aspiration or biopsy of any enlarged lymph nodes. Qualified participants will be randomly assigned (like the flip of a coin) to receive chemotherapy treatment with cisplatin (once every three weeks for four doses) or paclitaxel (once a week for 12 weeks for a total of 12 doses). Both drugs are given by intravenous (IV) infusion. During the study, participants will have additional physical exams, blood draws, biopsies, and tumor assessments. Surgery to remove the tumor will occur within six weeks after the last dose of chemotherapy.