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Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
North Shore Medical Center
Information provided by (Responsible Party):
Steven Isakoff, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00483223
First received: June 5, 2007
Last updated: November 10, 2014
Last verified: November 2014

June 5, 2007
November 10, 2014
June 2007
June 2014   (final data collection date for primary outcome measure)
  • 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 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
Complete list of historical versions of study NCT00483223 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
A Phase II Study of Cisplatin or Carboplatin 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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Cisplatin
    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
  • Drug: 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.
Experimental: Single Arm
Cisplatin or carboplatin (1 arm, 2 cohorts)
Interventions:
  • Drug: Cisplatin
  • Drug: carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
82
December 2016
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed invasive breast cancer with stage IV disease, according to AJCC 6th edition, either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study
  • All tumors must be ER-, PGR- and HER2-negative
  • 18 years of age or older
  • Paraffin tissue block is required from the primary tumor tissue or from diagnostic metastatic biopsy at time of relapse
  • Measurable disease by RECIST
  • Performance status of 0,1 or 2 by ECOG criteria
  • Life expectancy greater than 12 weeks
  • Normal organ and bone marrow function documented within 14 days prior to enrollment as defined by the protocol

Exclusion Criteria:

  • More than 1 prior chemotherapy for the treatment of recurrent or metastatic breast cancer
  • Prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents
  • Active brain metastases or unevaluated neurological symptoms suggestive of brain metastases
  • Intercurrent illness or other major medical condition or comorbid condition that might affect study participation
  • Significant history of uncontrolled cardiac disease such as uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased ejection fraction <45%
  • Renal dysfunction for which cisplatin dose would either require dose modification or would be considered unsafe
  • Pregnant or nursing women
  • History or other malignancy that was not treated with curative intent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00483223
06-412, TBCRC009
Yes
Steven Isakoff, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • North Shore Medical Center
Principal Investigator: Steven Isakoff, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP