Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

University of Oklahoma21 enrolled

Overview

To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

High-dose chemotherapyPROCEDURE

Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * breast carcinoma at first clinical evidence of metastatic disease * must have measurable disease by physical exam, x-ray, or scan * Age \< or equal to 55 * performance status 0-2 Exclusion Criteria: * can't have had more than one prior chemotherapy regimen * can't have had concurrent hormonal therapy * no brain metastases * no previous pelvic radiation * no history of another malignancy

Locations (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Quality of maximal response; time to initial disease progression; and overall survival

Time frame: undetermined

Secondary Outcomes

to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer

Time frame: undetermined

Data from ClinicalTrials.gov

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