Journal article
Palbociclib combined with fulvestrant in premenopausalwomen with advanced breast cancer and prior progression on endocrine therapy: PALOMA-3 results
S Loibl, NC Turner, J Ro, M Cristofanilli, H Iwata, SA Im, N Masuda, S Loi, F André, N Harbeck, S Verma, E Folkerd, KP Theall, J Hoffman, K Zhang, CH Bartlett, M Dowsett
Oncologist | WILEY | Published : 2017
Abstract
Background. The efficacy and safety of palbociclib, a cyclindependent kinase 4/6 inhibitor, combined with fulvestrant and goserelin was assessed in premenopausal women with advanced breast cancer (ABC) who had progressed on prior endocrine therapy (ET). Patients and Methods. One hundred eight premenopausal endocrine-refractory women ≥18 years with hormone receptor-positive (HR1)/human epidermal growth factor receptor 2-negative (HER22) ABC were among 521 women randomized 2:1 (347:174) to fulvestrant (500 mg)± goserelin with either palbociclib (125 mg/day orally, 3 weeks on, 1 week off) or placebo. This analysis assessed whether the overall tolerable safety profile and significant progression..
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Funding Acknowledgements
We are grateful to the patients, the investigators, and the study personnel who participated in the PALOMA-3 trial. The authors would also like to acknowledge the efforts of Maria Koehler, who led the study design and collaborated with investigators performing the biochemical analyses. The FSH, LH, and E2 data in the manuscript were generated by the Centre Royal Marsden Hospital. Fulvestrant was provided by AstraZeneca. This study has been presented in part as a poster discussion at the ASCO Annual Meeting, June 3-7, 2016, Chicago, IL, USA. Editorial support was provided by Susan Reinwald, Ph.D., of Complete Healthcare Communications, LLC, and was funded by Pfizer. This study was sponsored by Pfizer. Final approval of the manuscript rested solely with the authors.