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Breast Cancer Research and Treatment

, Volume 165, Issue 3, pp 585–592 | Cite as

A pilot study of cabergoline for the treatment of metastatic breast cancer

  • Ricardo Costa
  • C. A. Santa-Maria
  • D. M. Scholtens
  • S. Jain
  • L. Flaum
  • W. J. Gradishar
  • C. V. Clevenger
  • V. G. Kaklamani
Clinical Trial

Abstract

Purpose

The prolactin (PRL) receptor is over-expressed in breast cancer, and pre-clinical data indicate that it contributes to breast oncogenesis. Cabergoline is a potent dopamine receptor agonist of D2 receptors and has a direct inhibitory effect on pituitary PRL secretion.

Methods

A phase II study of cabergoline in patients with metastatic breast cancer was conducted. The primary end point of the study was to determine the clinical benefit rate (CBR) at 2 months. Eligible patients had tumors of any receptor status with no limit of prior lines of therapy. Measurable and unmeasurable diseases were allowed. Cabergoline 1 mg orally, twice weekly (1 cycle = 4 weeks) was given until disease progression or unacceptable toxicity. PRL receptor immunohistochemical staining was performed on available baseline tumor tissue; serial serum PRL levels were assessed.

Results

Twenty women were enrolled; 18 were evaluable for CBR. Tumor receptor status was distributed as follows: HR−any/HER2+ 2(10%), HR+/HER2− 18 (90%). The CBR was 33% (6/18), median progression free survival was 1.8 months, and median overall survival was 10.4 months. Two patients experienced disease control for over 12 months. Most common treatment-related adverse events were nausea (30%), fatigue (25%), and elevation in alkaline phosphatase (15%). Nine patients had baseline tissue for analysis; there was no association between baseline tumor PRL receptor expression and clinical benefit (p = 0.24). Change in serum PRL level and response were not correlated after 2 months of treatment (p = 0.64).

Conclusion

Cabergoline was well tolerated, and while the ORR was low, a small subset of patients experienced extended disease control.

Keywords

Breast cancer Cabergoline Serum prolactin Prolactin receptor 

Notes

Funding

This study was supported by Lynn Sage Breast Cancer Research Foundation, Dolores Knes Fund.

Compliance with ethical standards

Conflict of interest

No relevant disclosures from any authors.

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Copyright information

© Springer Science+Business Media, LLC 2017

Authors and Affiliations

  1. 1.Department of Breast Oncology, Lee Moffitt Cancer CenterMoffitt McKinley Outpatient CenterTampaUSA
  2. 2.Division of Hematology/Oncology, Feinberg School of MedicineNorthwestern UniversityChicagoUSA
  3. 3.Department of Preventive MedicineNorthwestern UniversityChicagoUSA
  4. 4.Department of PathologyVirginia Commonwealth UniversityRichmondUSA
  5. 5.Cancer Therapy and Research CenterUniversity of Texas Health Science Center San AntonioSan AntonioUSA

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