The purpose of this study is to determine whether Cisplatin when given with radiation
therapy prior to surgery is effective in improving response to treatment in breast cancer
patients. Tumor, blood and bone marrow samples will be collected in this study and will
also help researchers determine if cisplatin is able to change tumor DNA so it cannot
multiply itself and create more tumor cells, and cause the tumor cells to die.
After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative
Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow
aspiration Sentinel Lymph node biopsy, if axillary US negative
Week 1: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m2 (cycle 1) Days 2-5:
Week 2: Radiation Day 1-5: Radiation Therapy
Week 3: Radiation Days 1-5: Radiation Therapy
Week 4: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m2 (cycle 2) Days 2-5:
Week 5: Radiation Days 1-5: Radiation Therapy
Week 6: Radiation Days 1-5: Radiation Therapy
Week 7: Chemo Day 1: Cisplatin 75mg/m2 (cycle 3)
Week 10: Chemo Day 1:Cisplatin 75mg/m2 (cycle 4)
Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core
and FNA) Blood collection Bone marrow aspiration
Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin:
60mg/m2 & Cyclophosphamide: 600mg/m2, every 2 weeks for 4 cycles
Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m2 every 2
weeks for 4 cycles
Week 52 IVAD Removal, Bone marrow aspiration
Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years
- Patients must be >= 18 years of age
- Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
- Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).
- Tumor does not express the following biomarkers: estrogen receptor, progesterone
- Adequate organ function defined as:
- Serum Creatinine <= 1.5 x upper limit of institutional normal.
- ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.
- Bilirubin <= 1.5 x upper limit of institutional normal.
- Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.
- No evidence of distant metastasis present by CT, Bone scan, or physical exam. 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.
- No 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.
- Women of child bearing potential may not be currently pregnant or breastfeeding at
time of registration and must agree to use adequate contraception.
- Karnofsky Performance Status of <= 70.
- Patients with known history neural deficiencies (e.g. peripheral neuropathy).
- Patients with a known hearing impairment (hearing loss or severe tinnitus).
- Male patients