NCT00584428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 1992

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1992

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

9.8 years

First QC Date

December 20, 2007

Last Update Submit

November 20, 2019

Conditions

Breast Neoplasms

Keywords

Breast CancerCancer TreatmentBreast Cancer Treatment

Outcome Measures

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.

    Undetermined

Secondary Outcomes (1)

  • No secondary outcomes

    Undetermined

Study Arms (1)

1

EXPERIMENTAL
Procedure: High-Dose Chemo with Autologous BMT

Interventions

High-Dose Chemo with Autologous BMTPROCEDURE

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

1

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • George Selby, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

June 1, 1992

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

US(1)