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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Estrogen Receptor-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

baseline through end of study

Safety Issue:

No

Principal Investigator

Kathy Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

IU Simon Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

0607-18 IUCRO-0154

NCT ID:

NCT00577122

Start Date:

July 2007

Completion Date:

December 2013

Related Keywords:

  • Estrogen Receptor-negative Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Medroxyprogesterone progesterone acetate (MPA)
  • Cyclophosphamide plus Methotrexate
  • Breast Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
The University of Texas M. D. Anderson Cancer CenterHouston, Texas  77030
University of California, San Francisco Comprehensive Cancer CenterSan Francisco, California  94143-1770
University of North Carolina, Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599
Duke University Comprehensive Cancer CenterDurham, North Carolina  27710