NCT00012311

Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer

Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer: A Phase II Prospective Randomized Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if chemotherapy followed by peripheral stem cell transplantation is more effective than chemotherapy alone in treating metastatic breast cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation with that of chemotherapy alone in treating women who have stage IV breast cancer.

Detailed description

OBJECTIVES: I. Compare the efficacy of multi-course high-dose chemotherapy with autologous peripheral blood stem cell transplantation versus standard-dose chemotherapy in women with metastatic breast cancer. II. Compare the five year event-free survival, in terms of time to progression or time to death due to toxic effects, in patients treated with these regimens. III. Compare the response rate and overall survival of patients treated with these regimens. IV. Compare the toxicity of these regimens in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel and doxorubicin once followed by filgrastim (G-CSF) daily for approximately 1 week. Treatment repeats approximately every 3 weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate, and fluorouracil on days 7 and 8 every 4 weeks for 4 courses. Arm II: Patients receive docetaxel, doxorubicin, and G-CSF as in arm I for 3 courses. Patients undergo leukapheresis daily for 3 or 4 days. Patients then receive 1 course of ifosfamide, etoposide, and carboplatin daily for 4 days when blood counts recover, followed by 1 course of cyclophosphamide and thiotepa daily for 4 days. Patients undergo peripheral blood stem cell reinfusion following each course. PROJECTED ACCRUAL: A total of 264 patients (132 per arm) will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	CMF regimen
DRUG	carboplatin
DRUG	cyclophosphamide
DRUG	docetaxel
DRUG	doxorubicin hydrochloride
DRUG	etoposide
DRUG	fluorouracil
DRUG	ifosfamide
DRUG	methotrexate
DRUG	thiotepa
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 2000-01-01
• First posted: 2004-04-13
• Last updated: 2014-01-06

Locations

1 site across 1 country: United States