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Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.
OBJECTIVES: * Determine the effectiveness of neoadjuvant dose intensive sequential chemotherapy, followed by surgical resection, adjuvant therapy, and tandem high dose chemotherapy and stem cell rescue in patients with inflammatory stage IIIB breast cancer. * Determine the clinical and pathological remission rate (complete, partial, and overall) following neoadjuvant dose dependent sequential chemotherapy in patients with inflammatory stage IIIB breast cancer. * Determine the relapse and survival rate of these patients with the above therapy. * Determine the potential correlations between inflammatory features and hereditary background. OUTLINE: Patients are stratified according to those who have had no more than 1 cycle of neoadjuvant chemotherapy (stratum 1) and those who have had more than 1 cycle of neoadjuvant chemotherapy and/or modified radical mastectomy (stratum 2). Patients in stratum 1 receive doxorubicin IV over 96 hours on days 1-4, 15-19, and 29-32. Paclitaxel is infused over 96 hours on days 43-47 and 57-60. Filgrastim (G-CSF) is administered on days 5-10, 20-25, 33-38, 48-55, and 61-68, and beyond if the granulocyte count is less than 1000/mm\^3. A modified radical mastectomy is performed between days 70 and 80. All stratum 1 and stratum 2 patients then receive paclitaxel IV for 96 hours on days 100-104, and cyclophosphamide IV on day 121. Filgrastim is administered at one dose on days 105-110 and days 122-127 and at a higher dose on days 110-116 and days 128-135. Stem cells are harvested from the patient on days 113-116 and days 132-135. High-dose chemotherapy is then administered to all patients in the study. Course 1 starts with doxorubicin IV on days -7 to -3. Paclitaxel IV is administered for 24 hours on day -2. Filgrastim is administered by IV on day -1 and continued until the granulocyte count is greater than 1000/mm\^3 for 3 days. Peripheral stem cells are reinfused on day 0. Course 2 starts 4-6 weeks after the start of course 1 with melphalan and cisplatin being infused on day -11. Filgrastim is administered IV on days -10 to -6. Melphalan and cisplatin are administered again on day -4. Stem cells are infused on day -3 and on day 0. Filgrastim is then administered until the granulocyte count is at least 1000/mm\^3 for 3 days. Radiation therapy is started 4-7 weeks after the beginning of course 2. Tamoxifen is started within 2 weeks of discharge following course 2 in patients with hormone receptor positive tumors. Patients are followed every 3 months for two years and then annually for the next three years. PROJECTED ACCRUAL: Approximately 60 patients will be accrued, at a rate of about 15 per year.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Start Date
May 30, 1997
Primary Completion Date
February 9, 2010
Completion Date
November 6, 2025
Last Updated
February 20, 2026
41
ACTUAL participants
filgrastim
BIOLOGICAL
cisplatin
DRUG
cyclophosphamide
DRUG
doxorubicin hydrochloride
DRUG
melphalan
DRUG
mesna
DRUG
paclitaxel
DRUG
tamoxifen citrate
DRUG
bone marrow ablation with stem cell support
PROCEDURE
conventional surgery
PROCEDURE
peripheral blood stem cell transplantation
PROCEDURE
Lead Sponsor
City of Hope Medical Center
Collaborators
NCT05245812
NCT05673200
Data Source & Attribution
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