Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Thiotepa

• Registration Number: NCT00005798
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating women who have breast cancer.

Detailed Description

OBJECTIVES: I. Determine long term remission rates as measured by disease free survival in women with breast cancer treated with cyclophosphamide, thiotepa, and carboplatin followed by autologous hematopoietic stem cell transplantation. II. Determine the safety and efficacy of this combination chemotherapy regimen in this patient population.

OUTLINE: Peripheral blood stem cells (PBSC) are collected. Patients sequentially receive cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on days -6 to -4. PBSC are reinfused on day 0. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: At least 40 patients with 4-9 positive lymph nodes and at least 50 patients with 10 positive lymph nodes will be accrued for this study.

Study Timeline

• Study Start: 1995-07
• Study First Submitted: 2000-06-02
• Primary Completion: 2001-08
• Study First Submitted QC: 2004-04-01
• Study First Posted: 2004-04-02
• Study Completion: 2007-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CTC Conditioning Regimen	Carboplatin	Cyclophosphamide Thiotepa Carboplatin
CTC Conditioning Regimen	Cyclophosphamide	Cyclophosphamide Thiotepa Carboplatin
CTC Conditioning Regimen	Thiotepa	Cyclophosphamide Thiotepa Carboplatin

Primary Outcome Measures

Name	Time	Method
relapse-free survival	five years post transplant	relapse free survival determined by the Kaplan-Meier product-limit method

Secondary Outcome Measures

Name	Time	Method
Rate of Grade III/IV toxicities	five years post transplant	rate of grade III/IV toxicity

Trial Locations

Locations (3)

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Halifax Medical Center; 🇺🇸 Daytona Beach, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States