Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Cisplatin; carboplatin
Intervention description: 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.; 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.
Intervention MeSH terms: Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ER negative; PgR negative; HER2 negative; cisplatin; carboplatinum; platinum; p63; p73

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed invasive breast cancer with stage IV disease, according to
             AJCC 6th edition (American Joint Committee on Cancer), 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 (Eastern Cooperative Oncology Group)

          -  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