Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Translational Breast Cancer Research Consortium
• Treatments: Cyclophosphamide; Hormones; Medroxyprogesterone; Medroxyprogesterone Acetate; Methotrexate; Progesterone

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.