Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

University of Oklahoma (OU)

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Procedure: High-dose chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00584766

OU 8701

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

1

Experimental group

Treatment:

Procedure: High-dose chemotherapy