Munzone, Elisabetta
Fabi, Alessandra
Buono, Giuseppe
Caputo, Roberta
Montagna, Emilia
Negri, Mara
Nuzzo, Francesco
Palazzo, Antonella
Paris, Ida
Conti, Luca
Baggi, Anna
Franzini, Jean Marie
De Laurentiis, Michelino
Article History
Accepted: 26 November 2023
First Online: 21 December 2023
Declarations
:
: No funding (grants) was received for conducting the study. The study was sponsored by Roche S.p.A and conducted by BIP S.p.A. The SC formulation pertuzumab + trastuzumab (PH FDC SC), which at the start of the study was approved but not yet reimbursed by the Italian NHS, was given out freely from Roche S.p.A. to the centers involved, for a total of 42 patients.
: Elisabetta Munzone: Consulting or advisory role: Exact Sciences, MSD Oncology, Daiichi Sankyo/Astra Zeneca, Pfizer, Seagen, Ipsen. Travel, accommodation, expenses: Roche, Pfizer, Lilly, Novartis, Gilead Sciences, AstraZeneca, Pierre Fabre. Alessandra Fabi: Consulting or advisory role, travel accommodation or funding for scientific meetings from Roche, Novartis, Lilly, Pfizer, MSD, Dompè, Pierre Fabre, Eisai, Sophos, Epionpharma, Gilead, Seagen, Astra Zeneca, Exact Science. Giuseppe Buono: Received honoraria or speakers’ fee from Novartis, GSK, Eli-Lilly, Pfizer, AstraZeneca, Roche, Daiichi Sankyo, Exact Science, Genetic.Spa. Roberta Caputo: Ely Lilly, Novartis, Pfizer, Roche, Gilead, Seagen, Daichii Sankyo, Veracyte, MSD, Astra Zeneca, Exact Science. Emilia Montagna: Consulting and Advisory role for Pfizer and Novartis. Mara Negri: There are no competing interests to declare. Francesco Nuzzo: There are no competing interests to declare. Antonella Palazzo: MSD, Novartis, Pfizer, AZ/Daiichi Sankyo, Gilead (speakers’ invitation or grant travel). Ida Paris: Consulting or participation in advisory boards: Seagen, Novartis, Lilly, AstraZeneca, Gilead, MSD, Pfizer, Roche, Gentili. Travel accommodation, registration for international congresses: Novartis, Lilly, Roche, Gilead. Funding for organization of scientific events: Novartis, Lilly, Roche, Gentili. Luca Conti: There are no competing interests to declare. Anna Baggi: There are no competing interests to declare. Jean Marie Franzini: There are no competing interests to declare. Michelino De Laurentiis: Speaker’s honoraria, consulting honoraria, and advisory board honoraria from Novartis, Eli Lilly, Pfizer, Roche, Sophos, Genetic, Menarini, Daiichi-Sankyo, Seagen, Pierre Fabre, GSK, Takeda.
: The data supporting the conclusions of this study are in the possession of the corresponding author but are subject to limitations in terms of public availability, as they are proprietary to Roche S.p.a. Therefore, these data are not openly accessible. However, they can be obtained from the corresponding author upon reasonable request and with the necessary permissions from Roche S.p.a.
: The PHASTER study was conducted in three Italian hospitals. Each hospital underwent the process of ethical committee approval: European Institute of Oncology (IEO), (Milan); ethical committee (EC) approval: February 23rd, 2022 (Protocol ID R1625/22-1733). Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome); EC approval: February 17th, 2022 (Protocol ID 4764). Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale” (Naples), which was the pilot center supporting the research protocol design (study number SL44004) (Naples); EC approval: January 25th, 2022, (Executive Notice n.90).
: Data used for the analysis came from questionnaires administered onsite during patients' visits for their respective treatments. All patients provided written informed consent prior to participating in the study.
: No identifying details of the participants were disclosed in the manuscript. All information is anonymous, and the manuscript does not include images that may identify the participants.
: EM: Writing—review & editing, methodology. AF: Writing – review & editing, methodology. GB: Data curation, validation. RC: Data curation, validation. EM: Data curation, validation. MN: Data curation, validation. FN: Data curation, validation. AP: Data curation, validation. IP: Data curation, validation. LC: Writing—original draft, formal analysis, conceptualization, methodology. AB: Writing—original draft, formal analysis, conceptualization, methodology. JMF: Supervision. ML: Writing – review & editing, conceptualization, methodology.