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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
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft vs Host Disease focused on measuring chronic Graft vs Host Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 14, 2005
Last Updated
July 10, 2007
Sponsor
Stanford University
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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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