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

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Estrogen Receptor-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Intervention: Medroxyprogesterone progesterone acetate (MPA) (Drug); Medroxyprogesterone with Cyclophosphamide + Methotrexate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
Kathy Miller, MD, Principal Investigator, Affiliation: IU Simon Cancer Center

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical Benefit Rate (CR + PR + SD > 6 Months).

Secondary outcome:

Grade 3 or 4 Adverse Events Related to Treatment

MPA Trough Level > 50 ng/mL When Have Clinical Benefit

MPA Trough Concentration

Detailed description: PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 toxicity.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

University of California, San Francisco Comprehensive Cancer Center, San Francisco, California 94115, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina 27599, United States

Duke University Comprehensive Cancer Center, Durham, North Carolina 27710, United States

The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, United States

Additional Information

Starting date: July 2007
Last updated: September 24, 2014

Page last updated: August 23, 2015

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