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
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.
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
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
baseline through end of study
Kathy Miller, MD
IU Simon Cancer Center
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|The University of Texas M. D. Anderson Cancer Center||Houston, Texas 77030|
|University of California, San Francisco Comprehensive Cancer Center||San Francisco, California 94143-1770|
|University of North Carolina, Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599|
|Duke University Comprehensive Cancer Center||Durham, North Carolina 27710|