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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Estrogen Receptor-negative Breast Cancer Progesterone Receptor-negative Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort I (MPA)

Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.

Group Type EXPERIMENTAL

Medroxyprogesterone progesterone acetate (MPA)

Intervention Type DRUG

1000 mg po daily

Cohort II (MPA, low-dose chemotherapy)

Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.

Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.

Group Type EXPERIMENTAL

Medroxyprogesterone with Cyclophosphamide + Methotrexate

Intervention Type DRUG

Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week

Interventions

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Medroxyprogesterone progesterone acetate (MPA)

1000 mg po daily

Intervention Type DRUG

Medroxyprogesterone with Cyclophosphamide + Methotrexate

Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week

Intervention Type DRUG

Other Intervention Names

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(6alpha)-17-hydroxy-6-methylpregn-4-ene-3,20-dione 17alpha-hydroxy-6alpha-methylprogesterone 27408 520-85-4 6alpha-methyl-17alpha-hydroxyprogesterone 6alpha-methyl-4-pregnen-17alpha-ol-3,20-dione Curretab Depo-Provera Provera Provera Dosepak medroxyprogesterone acetate MPA cyclophosphamid monohydrate CTX methylaminopterin MTX

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No