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Completed

NCT Number: NCT00584428

High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer

To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed diagnosis of breast cancer
  • Age 18-70
  • Breast cancer at first clinical evidence of metastatic disease
  • Must have objectively measurable or evaluable disease or be in complete remission

Exclusion criteria

  • Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)
  • CNS involvement

Treatment and study plan

High-Dose Chemo with Autologous BMT

Procedure

Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70

Primary outcomes

  1. Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur.

    Time frame: Undetermined

Secondary outcomes

  1. No secondary outcomes

    Time frame: Undetermined

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Stephenson Cancer Center

Registry information

Official study title

High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer

Important dates

Study start
1992
Primary completion
2002
Study completion
2002
First posted
Jan 2, 2008
Registry last updated
Nov 25, 2019

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.

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