High Dose Chemotherapy and Autologous Transplant for Breast Cancer
Primary Purpose
Graft vs Host Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
high dose chemo and auto hematopoietic cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Graft vs Host Disease focused on measuring chronic Graft vs Host Disease
Eligibility Criteria
Inclusion Criteria: Stage II, III or IV breast cancer chemosensitive adequate organ function Exclusion Criteria: prior transplant, life threatening disease brain metastases
Sites / Locations
- Stanford University Cancer Center
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00186641
Brief Title
High Dose Chemotherapy and Autologous Transplant for Breast Cancer
Official Title
High Dose Chemotherapy and Peripheral Blood Progenitor Cell Rescue for Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To determine survival outcomes for patients with chemosensitive brest cancer after treatment with high dose chemotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease
Keywords
chronic Graft vs Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high dose chemo and auto hematopoietic cell transplant
Primary Outcome Measure Information:
Title
Survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage II, III or IV breast cancer
chemosensitive
adequate organ function
Exclusion Criteria:
prior transplant,
life threatening disease
brain metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ginna Laport, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Dose Chemotherapy and Autologous Transplant for Breast Cancer
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