Graft vs Host DiseasePhase 2NCT00186641
High Dose Chemotherapy and Autologous Transplant for Breast Cancer
A Phase 2 study testing high dose chemo and auto hematopoietic cell transplant in people with Graft vs Host Disease, run by Stanford University at 1 site in United States.
Trial summary
To determine survival outcomes for patients with chemosensitive brest cancer after treatment with high dose chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- high dose chemo and auto hematopoietic cell transplant
- Type of treatment
- Surgery or procedure
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 8 Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II, III or IV breast cancer
- chemosensitive
- adequate organ function
Who cannot join
- prior transplant,
- life threatening disease
- brain metastases
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Cancer Center
Stanford, California, 94305
About this study
Official title: High Dose Chemotherapy and Peripheral Blood Progenitor Cell Rescue for Patients With Breast Cancer
To determine survival outcomes for patients with chemosensitive brest cancer after treatment with high dose chemotherapy
- Conditions
- Graft vs Host Disease
- Being tested
- high dose chemo and auto hematopoietic cell transplant
- Keywords
- chronic Graft vs Host Disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose chemo and auto hematopoietic cell transplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Primary completion8 Feb 2008
- Study completion8 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ginna Laport, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186641
- Sponsor's protocol ID
- BMT42
- Status last verified
- Jun 2026
- First submitted
- 14 Sep 2005
- Last updated
- 5 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Chemotherapy and Peripheral Blood Progenitor Cell Rescue for Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00186641
- Acronym / sponsor ID
- BMT42
- Conditions
- Graft vs Host Disease
- Keywords
- chronic Graft vs Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Primary completion
- 8 Feb 2008 (actual)
- Study completion
- 8 Feb 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine survival outcomes for patients with chemosensitive brest cancer after treatment with high dose chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage II, III or IV breast cancer
- chemosensitive
- adequate organ function
Key exclusion criteria (3 listed)
- prior transplant,
- life threatening disease
- brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dose chemo and auto hematopoietic cell transplant | Procedure or surgery | – |
Primary outcome
Survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
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RecruitingPhase 1/2
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GVHD - Graft-Versus-Host Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ginna Laport, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high dose chemo and auto hematopoietic cell transplant in people with Graft vs Host Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.