Cabergoline in Metastatic Breast Cancer
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.
Recurrent Breast Cancer
Stage IV Breast Cancer
|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|
- 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.
- 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.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
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.
I. To evaluate overall response rate (ORR) of cabergoline in women with metastatic breast cancer.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730729
|Contact: Study Coordinator||(312)firstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Virginia G. Kaklamani, MD 312-695-0320 email@example.com|
|Principal Investigator: Virginia G. Kaklamani, MD|
|Principal Investigator:||Virginia Kaklamani||Northwestern University|