A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
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
- 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
- Patients with accessible tumor will be asked to provide an optional metastatic tumor
biopsy for correlative studies.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective response rate in patients with ER/PgR/HER2 negative metastatic breast cancer receiving platinum as first or second-line therapy.
Steven Isakoff, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|UCSF||San Francisco, California 941430324|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|Johns Hopkins University Medical Center||Baltimore, Maryland 21205|
|University Of Alabama-Birmingham||Birmingham, Alabama 35294|
|North Shore Medical Center||Salem, Massachusetts 01970|
|Georgetown - Lombardi Cancer Center||Washington, District of Columbia|