A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer
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)