NCT00186680

Brief Summary

Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+ hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Sep 1996

Longer than P75 for phase_1 breast-cancer

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

September 1, 1996

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

March 2, 2010

Status Verified

February 1, 2010

Enrollment Period

8.8 years

First QC Date

September 14, 2005

Last Update Submit

February 26, 2010

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility and safety

Secondary Outcomes (2)

  • efficiency of mobilization

  • tumor contamination

Interventions

high dose chemo then auto hematopoietic cell transplantPROCEDURE

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary breast cancer does not express CD34+
  • adequate organ function

You may not qualify if:

  • CNS disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ginna Laport

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

September 1, 1996

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

March 2, 2010

Record last verified: 2010-02

Locations

US(1)