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

Ricardo Costa, Cesar Santa-Maria, D. M. Scholtens, S. Jain, L. Flaum, W. J. Gradishar, C. V. Clevenger, V. G. Kaklamani

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)585-592
Number of pages8
JournalBreast Cancer Research and Treatment
Volume165
Issue number3
DOIs
StatePublished - Oct 1 2017
Externally publishedYes

Fingerprint

Prolactin Receptors
Breast Neoplasms
Prolactin
Neoplasms
Therapeutics
Dopamine Agonists
Serum
Nausea
Disease-Free Survival
Fatigue
Alkaline Phosphatase
Disease Progression
Carcinogenesis
Breast
cabergoline
Staining and Labeling
Survival

Keywords

  • Breast cancer
  • Cabergoline
  • Prolactin receptor
  • Serum prolactin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Costa, R., Santa-Maria, C., Scholtens, D. M., Jain, S., Flaum, L., Gradishar, W. J., ... Kaklamani, V. G. (2017). A pilot study of cabergoline for the treatment of metastatic breast cancer. Breast Cancer Research and Treatment, 165(3), 585-592. https://doi.org/10.1007/s10549-017-4370-x

A pilot study of cabergoline for the treatment of metastatic breast cancer. / Costa, Ricardo; Santa-Maria, Cesar; Scholtens, D. M.; Jain, S.; Flaum, L.; Gradishar, W. J.; Clevenger, C. V.; Kaklamani, V. G.

In: Breast Cancer Research and Treatment, Vol. 165, No. 3, 01.10.2017, p. 585-592.

Research output: Contribution to journalArticle

Costa, R, Santa-Maria, C, Scholtens, DM, Jain, S, Flaum, L, Gradishar, WJ, Clevenger, CV & Kaklamani, VG 2017, 'A pilot study of cabergoline for the treatment of metastatic breast cancer', Breast Cancer Research and Treatment, vol. 165, no. 3, pp. 585-592. https://doi.org/10.1007/s10549-017-4370-x
Costa, Ricardo ; Santa-Maria, Cesar ; Scholtens, D. M. ; Jain, S. ; Flaum, L. ; Gradishar, W. J. ; Clevenger, C. V. ; Kaklamani, V. G. / A pilot study of cabergoline for the treatment of metastatic breast cancer. In: Breast Cancer Research and Treatment. 2017 ; Vol. 165, No. 3. pp. 585-592.
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AU - Santa-Maria, Cesar

AU - Scholtens, D. M.

AU - Jain, S.

AU - Flaum, L.

AU - Gradishar, W. J.

AU - Clevenger, C. V.

AU - Kaklamani, V. G.

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N2 - 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.

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