Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Cisplatin; Cyclophosphamide; Doxorubicin
Intervention description: administered intravenously every 3 weeks for 4 doses; administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses; administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
Intervention MeSH terms: Cyclophosphamide; Cisplatin; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: germline mutation; BRCA1 mutation; BRCA2 mutation

Summary:

      This research study is a Phase II clinical trial. Phase II clinical trials test the
      effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well
      it works in treating a specific cancer. "Investigational" means that cisplatin is still being
      studied for use in this setting and that research doctors are trying to find out more about
      it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation
      carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer.
      Cisplatin has been approved by the FDA for treatment of other cancers.

      The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown
      to be active in the treatment of women with breast cancer and a BRCA mutation. In this study,
      we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide
      ("AC") that you might receive if you did not participate in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic confirmation of invasive breast cancer

          -  Stage: Clinical T1 >/= 1.0 cm, T2 or T3, N0-3, M0

          -  HER2 negative

          -  ER and PgR status by immunohistochemistry must be known. ER positive patients are
             allowed if physicain has determined neoadjuvant chemo is appropriate.

          -  Life expectancy greater than six months

          -  Use of an effective means of contraception is required

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Prior anthracycline or platinum based therapy

          -  Prior treatment for the current breast cancer, including chemotherapy, hormonal
             therapy, radiation or experimental therapy

          -  Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for
             DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer

          -  Peripheral neuropathy of any etiology that exceeds grade 1

          -  Significant hearing loss

          -  Renal dysfunction

          -  Use of other investigational or study agents

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to study drugs

          -  Uncontrolled intercurrent illness

          -  Any condition that would prohibit administration of corticosteroids

          -  Uncontrolled diabetes

          -  Pre-existing medical condition that would represent toxicity in excess of grade 1 as
             measured by CTCAE (unless not considered medically significant by the physician)

          -  Known HIV positive individuals on combination antiretroviral therapy