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

Completed · Phase 2

Conditions studied: Estrogen Receptor-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

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.

Key facts

Study ID

NCT00577122

Run by

Indiana University

People needed

30

Starts

2007-07-01

Expected to finish

2011-12-01

Last updated by the study team

2023-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, San Francisco Comprehensive Cancer Center — San Francisco, California, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of North Carolina, Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Duke University Comprehensive Cancer Center — Durham, North Carolina, United States
• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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