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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)585-592
Number of pages8
JournalBreast Cancer Research and Treatment
Issue number3
StatePublished - Oct 1 2017


  • Breast cancer
  • Cabergoline
  • Prolactin receptor
  • Serum prolactin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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