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

  • Clinical Trial
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Breast Cancer Research and Treatment Aims and scope Submit manuscript

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.

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Funding

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

Author information

Author notes

  1. Ricardo Costa and C. A. Santa-Maria had equal contribution to this manuscript.

Authors and Affiliations

  1. Department of Breast Oncology, Lee Moffitt Cancer Center, Moffitt McKinley Outpatient Center, 10920 North McKinley Drive, BR-Program, Tampa, FL, 33612, USA

    Ricardo Costa

  2. Division of Hematology/Oncology, Feinberg School of Medicine, Northwestern University, Chicago, USA

    C. A. Santa-Maria, S. Jain, L. Flaum & W. J. Gradishar

  3. Department of Preventive Medicine, Northwestern University, Chicago, USA

    D. M. Scholtens

  4. Department of Pathology, Virginia Commonwealth University, Richmond, USA

    C. V. Clevenger

  5. Cancer Therapy and Research Center, University of Texas Health Science Center San Antonio, San Antonio, USA

    V. G. Kaklamani

Authors
  1. Ricardo Costa
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  2. C. A. Santa-Maria
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  3. D. M. Scholtens
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  4. S. Jain
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Correspondence to Ricardo Costa.

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Costa, R., Santa-Maria, C.A., Scholtens, D.M. et al. A pilot study of cabergoline for the treatment of metastatic breast cancer. Breast Cancer Res Treat 165, 585–592 (2017). https://doi.org/10.1007/s10549-017-4370-x

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  • DOI: https://doi.org/10.1007/s10549-017-4370-x

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