Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00577122

Recruitment Status:

Completed

Sponsor:

Indiana University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00577122

Recruitment Status:

Completed

Sponsor:


Indiana University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.