PALOMA Clinical Trial Programme​

The efficacy and safety of IBRANCE® in combination with endocrine therapy (ET) has been evaluated in the PALOMA Clinical Programme (Palbociclib: Ongoing trials in the Management of breast cancer) involving 1 open label and 2 double-blind randomised controlled trials in over 1,350 women with hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (mBC).2-4​

​PALOMA-1 (Phase II; N=165) and PALOMA-2 (Phase III; N=666) evaluated IBRANCE® with letrozole as 1st line treatment for hormone receptor positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer,2,3 and PALOMA-3  (Phase III; N=521) evaluated IBRANCE® with fulvestrant for pre-/peri- and post-menopausal women with HR+/HER2-mBC who had progressed on previous ET.4​

​In these trials, IBRANCE® demonstrated significant efficacy in extending median progression-free survival (mPFS) when used in combination with ET vs ET alone in a wide range of HR+/HER2-mBC patients, both endocrine sensitive and endocrine resistant.2-4 IBRANCE® also significantly improved tumour response rates  vs ET alone,2-4 maintained quality of life,5,6 and showed a consistent and manageable safety profile across all trials.2-4,7​


Letrozole plus Palbociclib versus Letrozole plus placebo for first line treatment of HR+/HER2- mBC: updated analysis of 37 months follow-up of this multicentre, double blind phase 3 randomised controlled trial.3,8


​Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of  HR+/HER2-mBC that progressed on previous endocrine therapy: final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.4


  1. IBRANCE® Summary of Product Characteristics.​
  2. Finn RS, et al. Lancet Oncol. 2015;16(1):25-35.​
  3. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.​
  4. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. ​
  5. Harbeck N, et al. Ann Oncol. 2016;27(6):1047-1054.​
  6. Rugo HS, et al. ESMO 2016: poster 2627.​
  7. Verma S, et al. Oncologist. 2016;21:1165-1175.​
  8. Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.

Date of preparation: March 2020

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.