Expired Study
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St. Louis, Missouri 63110


Purpose:

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.


Study summary:

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: Radiation Therapy 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: Radiation Therapy 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 4-5


Criteria:

Inclusion Criteria: - 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 receptor, Her2/neu - 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. Exclusion Criteria: - 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


NCT ID:

NCT00603408


Primary Contact:

Principal Investigator
Rebecca Aft, MD, PhD
Washington University School of Medicine


Backup Contact:

N/A


Location Contact:

St. Louis, Missouri 63110
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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