Breast Cancer Clinical Trial

Cabergoline in Metastatic Breast Cancer

Summary

Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that elevated levels of the hormone prolactin might be associated with an increased risk of breast cancer. Cabergoline has been shown to lower prolactin levels in the blood.

The purpose of this study is to evaluate the effectiveness of cabergoline in treating metastatic breast cancer disease in those who test positive for the prolactin receptor.

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Full Description

PRIMARY OBJECTIVES:

I. To evaluate overall response rate (ORR) of cabergoline in women with metastatic breast cancer.

SECONDARY OBJECTIVES:

I. Evaluate the progression-free survival (PFS) and overall survival (OS). II. Evaluate toxicity. III. Correlate serum prolactin levels during therapy with response. IV. Evaluate within-patient changes in computed tomography (CT) and bone scan measurements taken at baseline and after 2 cycles of treatment.

V. Evaluate within-patient changes in prolactin receptor (PRLr) expression from baseline to after 1 cycle of treatment in those patients who consent to optional repeat biopsy.

OUTLINE:

Patients receive cabergoline orally (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must have histologically confirmed metastatic breast cancer; tissue (a minimum of 3 slides) from the most recent biopsy is required for review and confirmation of eligibility; NOTE: material should ideally be from the metastatic disease, however material from the primary tumor is acceptable if that is all that is available
Patients must have stage IV breast cancer
Patients must have tumors (primary or metastatic) that stain positively for the prolactin receptor

Patients may have measurable or evaluable disease

Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan
Evaluable disease is disease that does not meet the criteria for measurable disease; examples would include patients with effusions or bone-only disease
Women of childbearing potential must commit to the use of effective barrier (non-hormonal) contraception while on study
Patients must have a life expectancy of greater than 12 weeks
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment
Leukocytes >= 3,000/uL (microliter)
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Child Pugh score =< 10
Patients must be able to swallow and retain oral medication
All patients must have given signed, informed consent prior to registration on study

Exclusion Criteria:

Women who are pregnant or lactating are not eligible for study treatment
Patients who are undergoing concomitant radiotherapy are NOT eligible for participation
Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment is allowed with a 2 week washout period prior to registration
Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration
Patients who are receiving concomitant D2-antagonists (such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide) are NOT eligible for participation; patients must be off any such medications by the time of registration
Patients with known brain metastases are NOT eligible for participation

Patients with any of the following conditions or complications are NOT eligible for participation:

Uncontrolled hypertension
Known hypersensitivity to ergot derivatives
History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve (to be determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis)
History of pulmonary, pericardial, cardiac valvular, or retroperitoneal fibrotic disorders
Gastrointestinal (GI) tract disease resulting in an inability to take oral medication
Malabsorption syndrome
Require intravenous (IV) alimentation
History of prior surgical procedures affecting absorption
Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT01730729

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There is 1 Location for this study

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Northwestern University
Chicago Illinois, 60611, United States

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Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT01730729

Recruitment Status:

Completed

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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