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

Phase 0
18 Years
Open (Enrolling)
Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

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


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


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.


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.

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

- 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 =<

- 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

- 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

- 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

- Gastrointestinal (GI) tract disease resulting in an inability to take oral

- Malabsorption syndrome

- Require intravenous (IV) alimentation

- History of prior surgical procedures affecting absorption

- Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determining overall response using imaging scans

Outcome Description:

The response to study treatment will be assessed after 8 weeks (2 cycles) of therapy using CT scan images.

Outcome Time Frame:

After 8 weeks (2 cycles) of treament

Safety Issue:


Principal Investigator

Virginia Kaklamani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:

NU 12B06



Start Date:

November 2012

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms



Northwestern UniversityChicago, Illinois  60611