A Phase II Study of Preoperative Cisplatin versus Paclitaxel and Evaluation of a Biomarker Test in Women with Triple-Negative Breast Cancer

Full Title

A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients with Triple Negative Breast Cancer: Evaluating The Homologous Recombination Deficiency (HRD) Biomarker

Purpose

Chemotherapy is sometimes given before surgery to shrink breast cancer. In this study, doctors are evaluating a new test to see if it can predict how well a woman will respond to the anticancer drugs cisplatin or paclitaxel when given before surgery. Patients will be randomly assigned to receive cisplatin or paclitaxel, but not both.

Participants in this study include women with triple-negative breast cancer (which does not contain receptors for estrogen, progesterone, or HER2) who do not have mutations in the BRCA1 or BRCA2 genes or do not know their BRCA status. Researchers will evaluate a test called a homologous recombination deficiency (HRD) assay, which will be performed on patients' tumors, to see if it can predict how well a woman responds to cisplatin or paclitaxel given before surgery. The results of the test will be compared to each patient's amount of tumor shrinkage.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be women with stage I-III triple-negative breast cancer and no inherited BRCA mutations or unknown BRCA status.
  • Patients may not have had any prior treatment for breast cancer.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-5209.

Protocol

15-030

Phase

II

Investigator

Co-Investigators

Diseases