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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2010

Intervention(s) in this Clinical Trial

• Drug: Medroxyprogesterone progesterone acetate (MPA)
  • 1000 mg po daily
• Drug: Medroxyprogesterone Acetate with Cyclophosphamide plus Methotrexate
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
• Experimental: 2
  • 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.

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• To evaluate the toxicity of MPA and MPA + ldoCM in this patient population
  • Time Frame: baseline through end of treatment
    Safety Issue?: Yes
• To explore the relationship between MPA trough level and clinical benefit
  • Time Frame: baseline through end of treatment
    Safety Issue?: No
• To explore genetic determinants of MPA bioavailability and trough concentration
  • Time Frame: baseline through end of treatment
    Safety Issue?: No
• 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Indiana University

Overall Clinical Trial Officials and Contacts

Kathy Miller, MD Principal Investigator IU Simon Cancer Center  

Overall Contact: LaTrice Vaughn, RN 317-278-3730 lgvaughn@iupui.edu

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577122

Study ID Number: 0607-18 IUCRO-0154

ClinicalTrials.gov Identifier: NCT00577122

Health Authority: United States: Institutional Review Board

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