Hutchinson, Katherine E.
Chen, Jessica W.
Savage, Heidi M.
Stout, Thomas J.
Schimmoller, Frauke
Cortés, Javier
Dent, Susan
Harbeck, Nadia
Jacot, William
Krop, Ian
Trabucco, Sally E.
Sivakumar, Smruthy
Sokol, Ethan S.
Wilson, Timothy R. http://orcid.org/0000-0003-0530-4663
Funding for this research was provided by:
F. Hoffmann-La Roche
Article History
Received: 24 September 2022
Accepted: 14 April 2023
First Online: 26 April 2023
Declarations
:
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent to participate was obtained from all participants of the GO29058 (SANDPIPER) study. Approval for the analysis of samples from the Foundation Medicine database, including a waiver of informed consent and Health Insurance Portability and Accountability Act waiver of authorization, was obtained from the Western Institutional Review Board (protocol #20152817). The Institutional Review Board granted a waiver of informed consent under 45 CFR § 45.116 based on review and determination that this research meets the following requirements: (i) the research involves no more than minimal risk to the subjects; (ii) the research could not practicably be carried out without the requested waiver; and (iii) the waiver will not adversely affect the rights and welfare of the subjects.Details of the prospectively registered phase III SANDPIPER trial, as well as the presentation of the primary and secondary endpoints of the trial (clinicaltrials.gov: NCT02340221) were reported previously [CitationRef removed]. In brief, SANDPIPER studied the clinical efficacy of taselisib (GDC-0032) plus fulvestrant vs placebo plus fulvestrant in patients with ER+/HER2– <i>PIK3CA</i>mut locally advanced or metastatic BC. See InternalRef removed for additional details. SANDPIPER was approved by the relevant ethics bodies or institutional review boards (IRBs) at each participating site and conducted per the principles of the Declaration of Helsinki, International Council for Harmonisation Guidelines, and the laws and regulations of the countries in which it was conducted. All patients provided written informed consent for participation in the study, including tumor tissue and blood sampling and subsequent protocol-defined and exploratory biomarker analyses. SANDPIPER enrolled participants on the basis of a valid cobas® <i>PIK3CA</i> Mutation Test result from freshly collected or archival tumor tissue; both <i>PIK3CA</i>mut and <i>PIK3CA</i> mutation-not-detected (MND) were eligible.
: Not applicable.
: J.W. Chen, K.E. Hutchinson, H.M. Savage, T.J. Stout, F. Schimmoller, and T.R. Wilson are all employees of Roche/Genentech and own stock in Roche.J. Cortés: Consulting/Advisor: Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp&Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks, Reveal Genomics; Honoraria: Roche , Novartis , Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo; Research funding to the Institution: Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London; Stock: MedSIR, Nektar Pharmaceuticals, Leuko (relative); Travel, accommodation, expenses: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo, Astrazeneca, Gilead. Patents: “Pharmaceutical Combinations of A Pi3k Inhibitor And A Microtubule Destabilizing Agent. Javier Cortés Castán, Alejandro Piris Giménez, Violeta Serra Elizalde. WO 2014/199294 A” & “Her2 as a predictor of response to dual HER2 blockade in the absence of cytotoxic therapy. Aleix Prat, Antonio Llombart, Javier Cortés.US 2019/ 0338368 A1”.S. Dent: Honararia for consulting: Novartis, Astra Zeneca.N. Harbeck: Honoraria for lectures and/or consulting: Amgen, AstraZeneca, Daiichi-Sankyo, Exact Sciences, Gilead, Lilly, MSD, Novartis, Pierre-Fabre, Pfizer, Roche, Sandoz, Seagen.W. Jacot: Dr. Jacot reports grants, personal fees and non-financial support from Astra Zeneca; personal fees and non-financial support from Eisai, Novartis, Roche, Pfizer, Eli Lilly, and Chugai; personal fees from MSD, Bristol Myers Squibb, and Seagen; and grants and personal fees from Daiichi Sankyo, outside the submitted work.I. Krop: Honoraria from Genentech, AstraZeneca, and Celltrion; fees from a consulting or advisory role from Genentech/Roche, Seattle Genetics, Daiichi Sankyo, MacroGenics, Taiho Pharmaceutical, Context Therapeutics, Novartis, Merck, and Ionis; research funding from Genentech and Pfizer; employment/leadership/stock and other ownership interests (for an immediate family member) from AMAG Pharmaceuticals.S.E. Trabucco, S. Sivakumar, and E.S. Sokol are all employees of Foundation Medicine, a wholly owned subsidiary of Roche and are shareholders in Roche.