Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
|ClinicalTrials.gov Identifier: NCT00483223|
Recruitment Status : Completed
First Posted : June 6, 2007
Results First Posted : June 1, 2017
Last Update Posted : August 25, 2017
The purpose of this research study is to :
- Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER negative (estrogen-receptor-negative), PR negative (progesterone receptor-negative), HER2 negative (human epidermal growth factor receptor 2) 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Cisplatin Drug: carboplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2017|
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: Platinol
Given intravenously on the first day of each 3-week treatment cycle at AUC 6. 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: Paraplatin
- Objective Response Rate [ Time Frame: 3 years ]
Objective response rate (ORR) (complete response [CR]+ partial response [PR]) by RECIST (Response Evaluation Criteria In Solid Tumors).
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
- Response Rate Categorized by p63/p73 Ratio [ Time Frame: 3 years ]Response rate categorized by pre-specified ΔNp63/TAp73 expression ratio cutoff in the primary tumors from this patient cohort as a bio-marker to predict response to cisplatin or carboplatin. Response is defined as partial or completed response as determined by RECIST. Expression ratio was measured using quantitative RT-PCR (Reverse transcription polymerase chain reaction).
- Objective Response Rate Categorized by Subgroup [ Time Frame: 3 years ]The number of participants achieving an objective response (as determined by RECIST) categorized by treatment cohort and whether the treatment was first or second line treatment. First line treatment means that the drug used was the first drug used for the treatment of the primary cancer. Second line treatment means that a first line treatment failed to produce the desired response, so a new drug was used for treatment.
- Progression Free Survival and Overall Survival [ Time Frame: 5 years ]Median progression free survival and overall survival (progression determined using RECIST) during a median follow-up time of 50 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, D.C., 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|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|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|