Clinical trial · Interventional
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
NCT00577122CI-TRIAL-00070495completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Progesterone Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medroxyprogesterone progesterone acetate (MPA) | Drug | — | UNRESOLVED |
| Medroxyprogesterone with Cyclophosphamide + Methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I (MPA)
- description
- Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
- interventionNames
- Drug: Medroxyprogesterone progesterone acetate (MPA)
- type
- EXPERIMENTAL
- label
- Cohort II (MPA, low-dose chemotherapy)
- description
- Medroxyprogesterone 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.
- interventionNames
- Drug: Medroxyprogesterone with Cyclophosphamide + Methotrexate
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.