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180TiP - Palbociclib, trastuzumab and endocrine therapy (ET) versus treatment of physician's choice (TPC) in metastatic HER2-positive and hormone receptor-positive (HER2+/HR+) breast cancer (BC) with PAM50 luminal intrinsic subtype (SOLTI-1303 PATRICIA II): A randomized phase II trial


24 May 2020




Eva Ciruelos


Annals of Oncology (2020) 31 (suppl_2): S62-S82. 10.1016/annonc/annonc122


E.M. Ciruelos1, P. Villagrasa2, A.M. Antunes De Melo e Oliveira3, S. Pernas Simon4, J. Cortés5, S. Vazquez6, N. Martínez7, A. Perelló8, B. Bermejo De Las Heras9, E. Martínez10, I. Garau Llinas11, M. Mele Olive12, A. Montaño13, E. Vega14, B. Cantos15, M.J. Echarri16, T. Pascual17, P. Celiz18, X. González-Farré19, A. Prat17

Author affiliations

  • 1 Dept. Medical Oncology, Hospital 12 de octubre, 28041 - Madrid/ES
  • 2 Breast Cancer Research Group, SOLTI, 08008 - Barcelona/ES
  • 3 Dept. Medical Oncology, Vall d' Hebron University Hospital;; Vall d’Hebron Institute of Oncology, 08035 - Barcelona/ES
  • 4 Medical Oncology Breast Unit, ICO - Institut Català d'Oncologia l'Hospitalet (Hospital Duran i Reynals), 08908 - Hospitalet de Llobregat/ES
  • 5 Dept. Medical Oncology, IOB Institute of Oncology, Quiron group, 08023 - Barcelona/ES
  • 6 Medical Oncology Breast Unit, ICO - Institut Català d'Oncologia l'Hospitalet (Hospital Duran i Reynals), 08908 - L'Hospitalet de Llobregat/ES
  • 7 Dept. Medical Oncology, Ramon y Cajal Hospital, 28034 - Madrid/ES
  • 8 Dept. Medical Oncology, Hospital Universitari Son Espases, 07120 - Palma de Mallorca/ES
  • 9 Dept. Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 10 Dept. Medical Oncology, Consorcio Hospitalario Provincial de Castellón, 12002 - Castelló de la Plana/ES
  • 11 Dept. Medical Oncology, Hospital Son Llatzer, 07198 - Palma de Mallorca/ES
  • 12 Dept. Medical Oncology, Hospital Universitari Sant Joan de Reus, 43204 - Reus/ES
  • 13 Dept. Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Seville/ES
  • 14 Dept. Medical Oncology, Centro Integral Oncológico Clara Campal, 28050 - Madrid/ES
  • 15 Dev. Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, 28222 - Majadahonda/ES
  • 16 Dept. Medical Oncology, Hospital Severo Ochoa, 28911 - Leganes/ES
  • 17 Medical Oncology Department, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 18 Dept. Scientific, SOLTI Breast Cancer Research Group, 08008 - Barcelona/ES
  • 19 Dept. Medical Oncology, Hospital General de Catalunya, 08195 - San Cugat del Valles/ES

Abstract 180TiP


Efficacy interim results from PATRICIA phase II trial in HER2+/HR+ advanced BC showed that PAM50 luminal disease was associated with larger and clinically meaningful progression-free survival (PFS) following palbociclib, trastuzumab and endocrine therapy compared to PAM50 non-luminal disease (Ciruelos E. et al, SABCS 2018). Based on these preliminary results, PATRICIA II was designed to select patients based on PAM50 and to include a randomization to a control arm.

Trial design

PATRICIA II is a randomized open-label, adaptive design, phase II study. Patients must have centrally confirmed HR+/HER2+ and PAM50 Luminal A or B intrinsic subtype tumors and have received at least 1 (and no more than 4) prior lines of anti-HER2 regimens for locally advanced or metastatic BC. Patients are randomized 1:1 to trastuzumab plus palbociclib 125 mg/day orally 3 weeks on/1 week off and endocrine therapy (cohort C1) or treatment of physician’s choice (TPC): T-DM1 or chemotherapy (gemcitabine, vinorelbine, capecitabine, eribulin, paclitaxel or docetaxel) plus trastuzumab (cohort C2). ET options are either an aromatase inhibitor, fulvestrant or tamoxifen +/- ovarian suppression. Stratification factors include the number of previous regimens for advanced BC (1-2 vs 3-4) and the presence of visceral disease (yes vs no). Primary objective is to compare the PFS between two arms. The study has an 80% power with two-sided alpha=0.05 to detect a HR of 0.62 in favor of the palbociclib arm. An interim analysis (IA) adjusted for multiplicity from O’Brien-Fleming method and an estimation of the conditional power (CP) will be performed at 70% of the events. Secondary objectives include response rate, overall survival, safety, and Quality of Life. Tumor tissue and blood samples will be collected for biomarker analyses. A total of 516 patients will be screened and 232 patients will be recruited. As of January 16th, 2020, 7 patients were randomized in the trial. The study is sponsored by SOLTI and financially supported by Pfizer.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

SOLTI Breast Cancer Research Group.




E.M. Ciruelos: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer. P. Villagrasa: Speaker Bureau/Expert testimony: NanoString. M. Oliveira: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Puma Biotechnology; Research grant/Funding (institution): Philips Healthcare; Travel/Accommodation/Expenses: Grünenthal Group; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Pierre Fabre; Travel/Accommodation/Expenses: GP Pharm. S. Pernas Simon: Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Polyphor. J. Cortés: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy: Celgene; Advisory/Consultancy: Cellestia; Honoraria (self): Novartis; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self): Samsung; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dome; Shareholder/Stockholder/Stock options, Stock, patents and intellectual property: MedSIR; Research grant/Funding (institution): Bayer, Ariad pharmaceuticals, Guardan Health, Puma, Piqur Therapeutics, Queen Mary University; Advisory/Consultancy: Biothera Pharmaceutical; Advisory/Consultancy: Merus, Seattle Genetics; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Erytech; Advisory/Consultancy: Polyphor; Advisory/Consultancy: Servier; Advisory/Consultancy: Athenex; Research grant/Funding (institution): Baxalta GMBH. N. Martínez: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eisai; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer. E. Martínez: Advisory/Consultancy: Roche. X. González-Farré: Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Eisai. A. Prat: Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy: Lilly; Advisory/Consultancy: NanoString; Advisory/Consultancy, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy: Oncolytics Biotech; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Puma; Advisory/Consultancy: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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