Medroxyprogesterone acetate (MPA) was used for many years in women whose cancer was fueled by estrogen production. This type of breast cancer is referred to as hormone receptor positive (HR +). Recent laboratory studies suggested MPA may be effective in treating patients who are hormone receptor negative (HR-) meaning estrogen does not make their breast cancer grow. This phase II trial was conducted to evaluate the activity of MPA alone or in combination with low-dose chemotherapy in patients with metastatic, hormone receptor negative (HR-) breast cancer.
Translational Breast Cancer Research Consortium (TBCRC)
- Dana-Farber/ Harvard Cancer Center
- Duke University Medical Cancer Center
- Indiana University Simon Cancer Center
- University of Alabama, Birmingham
- University of California, San Francisco
- University of North Carolina, Chapel Hill
Date First Site Activated: September, 2006
Date Trial Closed to Enrollment: July, 2010
- Hormone Receptor negative (HR-)
- Post-menopausal
- No more than three prior chemotherapy regimens for metastatic disease
- ECOG Performance status < 2
- Adequate organ function
- No blood clot within the last 12 months
- No extensive fluid in the chest or abdomen
- Eligible women were assigned as follows:
- Group 1 - MPA alone group
- Group 2 - MPA with low-dose chemotherapy group
- Each group would initially enroll 15 patients.
- If less than two of the 15 patients had clinical benefit, that group would close.
- If 2 or more patients had clinical benefit, an additional 10 patients would be enrolled to that group.
- Blood samples and skin biopsies were collected to measure MPA concentration and the effect of MPA on markers of metastasis and blood vessel growth
- 30 patients were enrolled.
- 14 were treated with MPA alone
- 16 were treated with MPA in combination with low-dose chemotherapy.
- There were no measurable responses in either group.
- Five patients had stable disease but disease control was maintained for > 6 months in only 2 patients.
- The MPA concentration achieved in our study was much less than anticipated and in most patients was less than the levels needed for activity based on the laboratory studies.
- The markers of metastasis and new blood vessel formation didn’t change consistently.
Vaughn,L.G., Li, L., Nabell, L., Rugo, H.S., Carey, L.A., Kimmick, G.G., Steeg, P.S., Miller, K. A phase II study of medroxyprogesterone acetate (MPA) in patients (pts) with hormone receptor-negative (HR-) metastatic breast cancer (MBC): Translational Breast Cancer Research Consortium trial 007. 2010 ASCO, Poster, Abstract #1074.
Miller,K.D., Althouse,S.K., Nabell, L., Rugo, H., Carey, L., Kimmick,G., Jones, D.R., Merino, M.J., Steeg, P.S. A Phase II Study of Medroxyprogesterone Acetate in Patients with Hormone Receptor Negative Metastatic Breast Cancer: Translational Breast Cancer Research Consortium Trial 007. Breast Cancer Res Treat 148 (1): 2014.
*This summary was reviewed by: Kathy Miller, M.D. This summary was also reviewed and approved by the members of the TBCRC Patient Advocate Working Group.