A Phase II Study Assessing DNA Repair Status as a Marker of Response to Therapy in Patients with Triple-Negative Breast Cancer

Full Title

A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated with Concurrent Cisplatin and Radiation Therapy

Purpose

Triple-negative breast cancer cannot be treated with drugs that target estrogen, progesterone, or HER2 receptors, and is therefore very challenging to treat successfully. Radiation therapy and cisplatin are often components of therapy, but are not typically used together.

In this study, patients with locally recurrent or metastatic triple-negative breast cancer will receive radiation therapy and cisplatin concurrently. Researchers want to find out if analysis of tumor tissue from the biopsy, obtained before treatment began, can be helpful for predicting how well a patient subsequently responds to radiation therapy and cisplatin.

Specifically, they will be looking at the use of the pretreatment biopsy to predict the ability of tumor cells to repair their DNA (genetic material) after treatment. Radiation therapy and cisplatin damage a cancer cell’s DNA, but if the cell repairs that damage, the tumor can continue growing despite treatment. Pretreatment biopsy results may allow doctors to predict how well radiation therapy and cisplatin work for patients diagnosed with triple-negative breast cancer in the future.

Eligibility

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

  • Patients must have locally recurrent or metastatic triple-negative breast cancer that can be treated with radiation therapy.
  • Prior chemotherapy and radiation therapy are permitted, but must have stopped at least a week before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Simon Powell at 212-639-3639.

Protocol

15-032

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Diseases