Phase 2
N=30
Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer
Estrogen Receptor-negative Breast Cancer · Progesterone Receptor-negative Breast Cancer · Recurrent Breast Cancer · Stage IV Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00577122 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Sep 2014
Primary outcome: Primary: Clinical Benefit Rate (CR + PR + SD > 6 Months). — 7.1; 6.3 Percent of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Medroxyprogesterone progesterone acetate (MPA) (Drug); Medroxyprogesterone with Cyclophosphamide + Methotrexate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate (CR + PR + SD > 6 Months). |
7.1; 6.3 | — |
| SECONDARY Grade 3 or 4 Adverse Events Related to Treatment |
2; 2 | — |
| SECONDARY MPA Trough Level > 50 ng/mL When Have Clinical Benefit |
1; 1 | — |
| SECONDARY MPA Trough Concentration |
14.5; 42.1; 52.6; 66.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00577122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.