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E-Poster Display

351TiP - SOLTI-1507: A phase Ib study of ipatasertib and anti-HER2 therapy in HER2-positive advanced breast cancer with PIK3CA mutation (IPATHER)


17 Sep 2020


E-Poster Display


Tumour Site

Breast Cancer


Mafalda Oliveira


Annals of Oncology (2020) 31 (suppl_4): S348-S395. 10.1016/annonc/annonc268


M. Oliveira1, P. Villagrasa2, E.M. Ciruelos3, J. Gavilá4, A. Cortegoso5, F. Henao6, E. Vega7, J. Salvador8, V. Quiroga9, L. G Estevez10, S. Morales11, P. Tolosa3, F. Salvador2, X. Gonzalez12, C. Saura1

Author affiliations

  • 1 Medical Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 2 Clinical Research, SOLTI Breast Cancer Research Group, 8008 - Barcelona/ES
  • 3 Medical Oncology Dept, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 4 Department Of Medical Oncology, Instituto Valenciano de Oncología, Valencia/ES
  • 5 Servicio Oncología Médica, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela/ES
  • 6 Medical Oncology, Hospital Virgen de Macarena, Sevilla/ES
  • 7 Medical Oncology, Centro Integral Oncológico Clara Campal, Madrid/ES
  • 8 Medical Oncology, Hospital Virgen del Rocío, Sevilla/ES
  • 9 Medical Oncology, Badalona-Applied Research Group in Oncology (B-ARGO Group), Catalan Institute 
of Oncology, Barcelona/ES
  • 10 Medical Oncology, Hospital MD Anderson Cancer Center Madrid, Madrid/ES
  • 11 Medical Oncology, Hospital Universitario Arnau de Vilanova, 25198 - Lleida/ES
  • 12 Medical Oncology, Institut Oncològic Dr. Rosell, Barcelona/ES


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Abstract 351TiP


The combination of trastuzumab, pertuzumab (HP) and a taxane increases progression-free survival (PFS) and overall survival (OS) in patients with HER2-positive (HER2+) advanced breast cancer (BC). PIK3CA mutations can occur in 30-35% of HER2+ tumors, independently of hormone receptor (HR) status. In an exploratory analysis from CLEOPATRA, patients with a tumor harboring a PIK3CA mutation (mut) had a shorter PFS. The AKT inhibitor ipatasertib (IPAT) blocks the PI3K/AKT pathway and has activity in PI3K/AKT-altered tumors. We hypothesize that ipatasertib + HP is safe and can be beneficial in patients with PIK3CAmut HER2+ BC.

Trial design

This is an open label, single arm, phase Ib study to evaluate the safety and preliminary efficacy of IPAT plus HP (+/- endocrine therapy [ET]) in up to 25 patients with unresectable locally advanced or metastatic HER2+ BC with a PIK3CA mut (tissue or plasma ctDNA) candidates to receive maintenance HP (+/- ET) after taxane discontinuation for a reason different to progressive disease. The primary endpoint is to define the maximum tolerated dose (MTD) and the recommended phase II dose of the combination. MTD is defined as the highest dose level at which ≤1 of 6 subjects experience a dose limiting toxicity (DLT) during the first 28 days of treatment. Grade ≥3 diarrhea for more than 72 hours or Grade ≥2 diarrhea for more than 5 days is considered a DLT. Secondary endpoints include objective response rate, duration of response, clinical benefit rate and PFS. Exploratory objectives include identification of molecular biomarkers of response to treatment both in ctDNA (Amplicon-seq) and tumor tissue (Breast Cancer 360 panel), as well as to characterize the pharmacokinetics of study drugs. Given the low risk for overlapping toxicities, full doses of IPAT (400mg orally once daily D1-21 q28d) and standard dose HP will be used in the first cohort. Dose reductions of IPAT (300mg and 200mg) are allowed if full dose exceeds MTD. Loperamide is given as prophylaxis for diarrhea. In HR-positive tumors, ET may be started after the DLT period.

Clinical trial identification

EudraCT: 2019-001526-94; NCT04253561.

Editorial acknowledgement

Legal entity responsible for the study

SOLTI Breast Cancer Research Group.


Hoffmann-La Roche.


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. P. Villagrasa: Honoraria (self), Speaker: Nanostring. 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: Pfizer. J. Gavilá: Honoraria (self), Research grant/Funding (self): Novartis; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Roche. A. Cortegoso: Travel/Accommodation/Expenses: Roche; Honoraria (self): SOLTI. V. Quiroga: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony: Eisai; Travel/Accommodation/Expenses: BMS; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Kern. X. Gonzalez: Honoraria (self): SOLTI; Honoraria (self), Non-remunerated activity/ies: Roche; Honoraria (self): Eisai. C. Saura: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Celgene; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Genomic Health; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Sharp and Dhome España S.A.; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Odonate Therapeutics; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Philips Healthwork; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy, Travel/Accommodation/Expenses: priME Oncology; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Puma; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Synthon ; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Honoraria (institution): Lilly; Honoraria (institution): Genentech; Honoraria (institution): Immunomedics; Honoraria (institution): Macrogenics; Honoraria (institution): Piqur Therapeutics; Honoraria (institution): Zenith Pharma. All other authors have declared no conflicts of interest.

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