Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Triple Negative Breast Neoplasms; Breast Neoplasms
Intervention: Cisplatin; Carboplatin; Radiation therapy; Mastectomy (recommended but not mandatory)
Intervention MeSH terms: Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether platinum-based chemotherapy (either
      cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective
      in improving response to treatment in triple negative breast cancer patients. This treatment
      is being studied in this type of breast cancer because it does not respond well to commonly
      used treatments such as tamoxifen or herceptin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be > or = 18 years of age

          -  Patient must be female

          -  Patient must have primary invasive ductal breast adenocarcinoma that either:

               1. is newly diagnosed, without previous systemic treatment OR

               2. has failed to respond to < or = 4 cycles of neoadjuvant anthracycline based
                  therapy as assessed by clinical exam or imaging studies (mammogram, ultrasound or
                  breast MRI).

          -  Patient's tumor must be classified as clinically stage T2, T3, or T4 with any N (NX,
             N0, N1, N2, or N3) prior to any neoadjuvant treatment.

          -  Patient must have an ECOG Performance Status of < or = 1.

          -  Patient must have adequate organ function defined as:

               1. Renal Function:

                    1. CrCl ≥ 60 ml/min for patients receiving cisplatin

                    2. CrCl ≥ 30 ml/min for patients receiving carboplatin.

               2. Liver Function:

                    1. ALT, AST, ALK Phos < or = 1.5 x upper limit of institutional normal.

                    2. Bilirubin < or = 1.5 x upper limit of institutional normal.

               3. Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.

               4. Hematologic:

                    1. Absolute Neutrophil Count > or = 1500/mcl

                    2. Platelets > or = 100,000/mcl

                    3. Hemoglobin > or = 8.0 g/dl

          -  Patient must be able and willing to sign informed consent document.

        Exclusion Criteria:

          -  Patient must not have evidence of distant metastasis present by CT, bone scan, or
             PET-CT. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of
             these lesions should be further clarified by additional testing such as PET or MRI at
             the discretion of the treating physician.

          -  Patients having received neoadjuvant anthracycline based therapy must undergo
             restaging to exclude distant metastases prior to enrollment.

          -  Patient must not have had any prior malignancies with the exception of curatively
             treated basal or squamous carcinoma of the skin or history of previous malignancies,
             treated with at least greater than 5 years disease free survival.

          -  Patient's tumor must not express the following biomarkers or must have Allred score <
             4 for: estrogen receptor, progesterone receptor, and is not Her2/neu amplified.

          -  Women of child bearing potential may not be currently pregnant or breastfeeding at
             time of registration and must agree to use adequate contraception.

          -  Patient must have > or = grade 2 peripheral neuropathy.

          -  Patient must have a known hearing impairment (hearing loss or severe tinnitus).
             Hearing test will be performed at the discretion of the treating physician.

          -  Patient must not have been previously treated with cisplatin or carboplatin for any
             condition.