Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer
MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial
2 other identifiers
interventional
30
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2007
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 18, 2007
CompletedFirst Posted
Study publicly available on registry
December 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
September 23, 2014
CompletedOctober 16, 2023
October 1, 2023
4.4 years
December 18, 2007
September 16, 2014
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Benefit Rate (CR + PR + SD > 6 Months).
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.
baseline through end of study, up to 3 years
Secondary Outcomes (3)
Grade 3 or 4 Adverse Events Related to Treatment
baseline through end of treatment
MPA Trough Level > 50 ng/mL When Have Clinical Benefit
baseline through end of treatment
MPA Trough Concentration
Cycle 1 (Day 10-14) and Cycle 2 (Day 1)
Study Arms (2)
Cohort I (MPA)
EXPERIMENTALMedroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cohort II (MPA, low-dose chemotherapy)
EXPERIMENTALMedroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose. Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.
Interventions
1000 mg po daily
Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
- Primary tumor must be ER negative and PR negative
- Patients must be post-menopausal
- Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease
- Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol
- Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required
You may not qualify if:
- Patients must not have extensive pleural effusion or ascites
- Patients must not have history of DVT or pulmonary embolism w/in past 12 mo
- Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry
- Patients must not have had radiation therapy within 1 week of study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California, San Francisco Comprehensive Cancer Center
San Francisco, California, 94115, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of North Carolina, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathy Miller, MD
- Organization
- IndianaU
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Miller, MD
IU Simon Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ballvé-Lantero Professor of Medicine
Study Record Dates
First Submitted
December 18, 2007
First Posted
December 19, 2007
Study Start
July 1, 2007
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 16, 2023
Results First Posted
September 23, 2014
Record last verified: 2023-10