Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate in patients with locally advanced TN tumors who received radiation combined with cisplatin
Obtain preliminary information on the relationship between tumor response in patients with locally advanced triple negative breast cancer treated with cisplatin based chemoradiation correlates with deficiencies in DNA repair mechanisms.
5 years
No
Rebecca Aft, MD, PhD
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
07-0913
NCT00603408
December 2007
December 2009
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |