Overview

This trial is active, not recruiting.

Conditions estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer, recurrent breast cancer, stage iv breast cancer
Treatments medroxyprogesterone progesterone acetate (mpa), medroxyprogesterone with cyclophosphamide + methotrexate
Phase phase 2
Sponsor Indiana University
Collaborator Translational Breast Cancer Research Consortium
Start date July 2007
End date December 2011
Trial size 31 participants
Trial identifier NCT00577122, 0607-18 IUCRO-0154, TBCRC 007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
medroxyprogesterone progesterone acetate (mpa) (6alpha)-17-hydroxy-6-methylpregn-4-ene-3,20-dione
1000 mg po daily
(Experimental)
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.
medroxyprogesterone with cyclophosphamide + methotrexate medroxyprogesterone acetate
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

Primary Outcomes

Measure
To determine the clinical benefit rate (CR + PR + SD > 6 months) of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer.
time frame: baseline through end of study

Secondary Outcomes

Measure
To evaluate the toxicity of MPA and MPA + ldoCM in this patient population
time frame: baseline through end of treatment
To explore the relationship between MPA trough level and clinical benefit
time frame: baseline through end of treatment
To explore genetic determinants of MPA bioavailability and trough concentration
time frame: baseline through end of treatment
To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma TSP-1, change in plasma PAI-1 antigen and activity.
time frame: baseline through end of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Kathy Miller, MD
Description PRIMARY OBJECTIVES: I. To determine the clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD] >= 6 months) of medroxyprogesterone acetate (MPA) monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. SECONDARY OBJECTIVES: I. To evaluate the toxicity of MPA and MPA + ldoCM in this patient population. II. To explore the relationship between MPA trough level and clinical benefit. III. To explore genetic determinants of MPA bioavailability and trough concentration. IV. To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma thrombospondin (TSP)-1, change in plasma plasminogen activator inhibitor (PAI)-1 antigen and activity. OUTLINE: Patients are assigned to 1 of 2 treatment arms. COHORT I: Patients receive MPA orally (PO) once daily (QD). COHORT II: Patients receive MPA as in Cohort I, cyclophosphamide PO QD, and methotrexate PO twice daily (BID) on days 1 and 2 of every week. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Indiana University.