Skip to main content
OpenTrials
Completed

NCT Number: NCT00584766

Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-dose chemotherapy

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

Primary outcomes

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

    Time frame: undetermined

Secondary outcomes

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

    Time frame: undetermined

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Intensive Combination Chemotherapy With Autologous Bone Marrow Rescue for Metastatic Breast Cancer After Intitial Cytoreduction With Standard Agents: A Phase II Study

Important dates

Study start
1987
Primary completion
2002
Study completion
2002
First posted
Jan 2, 2008
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.