Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

1987-10-31

Study Completion Date

2002-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

High-dose chemotherapy

Intervention Type PROCEDURE

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

Interventions

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High-dose chemotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No