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Clinical Trials/NCT00584428
NCT00584428CompletedNot Applicable

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

University of Oklahoma2 sites in 1 country61 target enrollmentStarted: June 1992Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
2
Primary Endpoint
Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • No secondary outcomes(Undetermined)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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