The purpose of this research study is to :
- Determine how effective cisplatin is in slowing the time it takes for ER negative, PR negative, HER2 negative breast cancer to progress. Cisplatin is an anti-cancer chemotherapy drug that stops cancer cells from growing abnormally and is used to treat other cancers.
- Evaluate a new biomarker to help determine which breast cancers are most likely to respond to cisplatin chemotherapy
The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive to cisplatin, and that a subgroup of those patients may have a marker in their tumors that predicts response.
Primary Outcome Measures:
- To determine the objective response rate in patients with ER/PgR/HER2 negative metastatic breast cancer receiving cisplatin as first-line therapy.
- To evaluate the expression of p63/p73 in primary tumors from this patient cohort as a biomarker to predict response to cisplatin
Secondary Outcome Measures:
- To determine the progression free survival, clinical benefit rate, and overall survival in patients with triple-negative metastatic breast cancer receiving first line cisplatin therapy
- To evaluate the safety and toxicity of cisplatin therapy in this patient population.
- To conduct correlative studies to learn more about the biology of triple negative breast cancer.
Estimated Enrollment: |
39 |
Study Start Date: |
June 2007 |
This study is a Phase 2 study designed to evaluate cisplatin as first line therapy in metastatic triple negative (ER negative, PR negative, Her2 Negative) breast cancer and to evaluate the expression of p63/p73 as a biomarker to predict response.
- Participants will be given a cisplatin infusion intravenously on the first day of each treatment cycle. Each treatment cycle will last 3 weeks.
- During all treatment cycles participants will have a physical exam (including weight and vital signs) and they will be asked general questions about their health and any medications they may be taking, as well as specific questions about any side effects they may be experiencing while receiving study treatment.
- During every treatment cycle participants will have standard blood tests to check blood counts, liver and kidney function, and a blood marker for you particular type of cancer.
- CT scans will be taken of the participants tumor every 2 to 3 cycles to assess the response of the tumor to cisplatin.
- Participants will be in this study for as long as they tolerate the study treatment and their disease does not get any worse.
- Participants will be required to have a sample of their original tumor sent to Massachusetts General Hospital for correlative studies.