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Cabergoline in Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Collaborator:
Lynn Sage Foundation
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT01730729
First received: November 15, 2012
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: cabergoline
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Determining overall response using imaging scans [ Time Frame: After 8 weeks (2 cycles) of treament ] [ Designated as safety issue: No ]
    The response to study treatment will be assessed after 8 weeks (2 cycles) of therapy using CT scan images.


Secondary Outcome Measures:
  • Survival Rates [ Time Frame: 1st dose to date of progression of disease ] [ Designated as safety issue: No ]
    Patients will be followed-up with from first dose of study drug to date of disease progression.

  • Treatment toxicity as measured by adverse events experienced while on treatment [ Time Frame: After every 4 weeks (1 cycle) ] [ Designated as safety issue: Yes ]
    Toxicity will be assessed after 4 weeks (1 cycle).

  • Change in imaging measurements at baseline and after 2 cycles [ Time Frame: At baseline to 8 weeks ] [ Designated as safety issue: No ]
    At baseline and after 2 cycles changes CT and bone scan measurements will be evaluated.

  • Change in prolactin receptor expression measurements at baseline and after 1 cycle [ Time Frame: At baseline and after 4 weeks (1 cycle) ] [ Designated as safety issue: No ]
    Evaluate prolactin expression from baseline and after 4 weeks (1 cycle) of treatment. By measuring prolactin measurement in biopsy tissue.

  • Evaluate biomarkers and correlate with response to therapy [ Time Frame: After 4 weeks (1 cycle) ] [ Designated as safety issue: No ]
    Measure biomarkers after 4 weeks (1 cycle) and correlate with patient response to treatment.


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (cabergoline)
Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: cabergoline
Given orally
Other Names:
  • Dostinex
  • FCE 21336

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730729

Contacts
Contact: Study Coordinator (312)695-1301 cancertrials@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Virginia G. Kaklamani, MD    312-695-0320    v-kaklamani@northwestern.edu   
Principal Investigator: Virginia G. Kaklamani, MD         
Sponsors and Collaborators
Northwestern University
Lynn Sage Foundation
Investigators
Principal Investigator: Virginia Kaklamani Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01730729     History of Changes
Other Study ID Numbers: NU 12B06, NCI-2012-02039, STU00071477
Study First Received: November 15, 2012
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cabergoline
Anti-Dyskinesia Agents
Antineoplastic Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014