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

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status

Completed

Conditions

Breast Neoplasms

Treatments

Procedure: High-Dose Chemo with Autologous BMT

Study type

Interventional

Funder types

Other

Identifiers

NCT00584428
OU 9206

Details and patient eligibility

About

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.

Full 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

Enrollment

61 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

1
Experimental group
Treatment:
Procedure: High-Dose Chemo with Autologous BMT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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