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NCT00577122 · ClinicalTrials.gov registry record · Phase 2
Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer
A Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Cancer, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 7
- Study locations
NCT00577122: Completed Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Cancer, sponsored by Indiana University.
NCT00577122 is a Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Cancer that has completed, run by Indiana University. The registered enrollment target is 30 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (55% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00577122, a Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Cancer, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.
Primary Outcome
To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease \> 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.
Conditions Studied
Interventions
- DRUG Medroxyprogesterone progesterone acetate (MPA)
- DRUG Medroxyprogesterone with Cyclophosphamide + Methotrexate
Study Locations (7)
North Carolina
- University of North Carolina, Lineberger Comprehensive Cancer Center - Chapel Hill
- Duke University Comprehensive Cancer Center - Durham
Alabama
- University of Alabama at Birmingham - Birmingham
California
- University of California, San Francisco Comprehensive Cancer Center - San Francisco
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Massachusetts
- Dana-Farber Cancer Institute - Boston
Texas
- The University of Texas M. D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-07 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00577122 record still lists
NCT00577122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (55% lower).
The record links to 4 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Medroxyprogesterone progesterone acetate (MPA) is the first listed.
NCT00577122 lists 7 locations in 6 states (North Carolina, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT00577122 about?
NCT00577122 is a clinical study titled "Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer". The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.
What is the current status of trial NCT00577122?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2007-07. Estimated completion is 2011-12.
What conditions does trial NCT00577122 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Cancer, Estrogen Receptor-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer.
What interventions are being tested in trial NCT00577122?
The interventions under investigation include: Medroxyprogesterone progesterone acetate (MPA) (DRUG), Medroxyprogesterone with Cyclophosphamide + Methotrexate (DRUG).
Who is sponsoring clinical trial NCT00577122?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00577122 being conducted?
This trial has 7 study locations across Alabama, California, Indiana, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00577122's enrollment target sits among peer trials
30 16th of 30 higher than 13 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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