Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
The purpose of this research study is to :
- Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER negative, PR negative, HER2 negative breast cancer to progress. Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop 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 platinum, and that a subgroup of those patients may have a marker in their tumors that predicts response.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response|
- To determine the objective response rate in patients with ER/PgR/HER2 negative metastatic breast cancer receiving platinum as first or second-line therapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To evaluate the expression of p63/p73 in primary tumors from this patient cohort as a biomarker to predict response to platinum [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To determine the progression free survival, clinical benefit rate, and overall survival in patients with triple-negative metastatic breast cancer receiving first line platinum therapy [ Time Frame: TBD ] [ Designated as safety issue: No ]
- To evaluate the safety and toxicity of platinum therapy in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To conduct correlative studies to learn more about the biology of triple negative breast cancer. [ Time Frame: TBD ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Cisplatin or carboplatin (1 arm, 2 cohorts)
Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
Other Name: PlatinolDrug: carboplatin
Given intravenously on the first day of each 3-week treatment cycle at AUC6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
This study is a Phase 2 study designed to evaluate cisplatin/carboplatin as first or second 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 or carboplatin infusion intravenously on the first day of each treatment cycle. Each treatment cycle will last 3 weeks. Treating physician will select agent up to 41 patients in each cohort. Final primary endpoint analysis will use combined cis/carbo results.
- 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, or a sample from a metastatic diagnostic biopsy.
- Patients with accessible tumor will be asked to provide an optional metastatic tumor biopsy for correlative studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483223
|United States, Alabama|
|University of Alabama-Birmingham|
|Birmingham, Alabama, United States|
|United States, California|
|San Francisco, California, United States|
|United States, District of Columbia|
|Georgetown - Lombardi Cancer Center|
|Washington, District of Columbia, United States|
|United States, Maryland|
|Johns Hopkins University Medical Center|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|North Shore Medical Center|
|Peabody, Massachusetts, United States, 01960|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States|
|Principal Investigator:||Steven Isakoff, MD, PhD||Massachusetts General Hospital|