Real-world clinical and patient-reported outcome data in patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (mBC) treated with trastuzumab deruxtecan (T-DXd): Updated design of the PROVIDENCE study

Aim: Real-world effectiveness, health-related quality of life (HRQoL), treatment patterns, and safety of patients with mBC who are treated with the antibody-drug conjugate (ADC) T-DXd are evaluated in this study.

Methods: PROVIDENCE (NCT05573893) is a German, multicenter (approx. 100 sites), prospective, non-interventional study of patients with HER2+and HER2-low mBC treated with T-DXd according to the EMA label. Following a protocol amendment from AUG2024, patients are eligible independent of the line of treatment and up to 30 days after T-DXd start. Previously, retrospective study enrollment was not allowed and patients with a HER2+tumor had to receive T-DXd in second line.

Primary endpoint is time to next treatment 1 (TTNT1). Secondary endpoints are changes in HRQoL at 6 months based on the FACT-Breast and -General questionnaires. Exploratory endpoints include the change in HRQoL over time based on FACT-B and EQ-5D, overall response rate, progression-free and overall survival, time to treatment discontinuation, and safety. Endpoints will be analyzed separately for each HER2 cohort (~400 patients each). Moreover, the use of digital health applications (DiGAs) will be described, of which the patients must be informed.

Patients are followed up for up to 5 years. First-patient-in was on 12SEPT2023. Primary completion date is estimated for Q2 2032.

Summary: PROVIDENCE will analyze real-world treatment outcomes of T-DXd in patients with HER2+and HER2-low mBC in Germany.

 

MissingLinkText

Interessenskonflikt

Ich erkläre als korrespondierende/r AutorIn, dass ich oder einer bzw. mehrere meiner Ko-AutorenInnen während der letzten 3 Jahre wirtschaftliche oder persönliche Verbindungen im oben genannten Sinne hatten: Interessenskonflikt Details: Hans Tesch: Anstellungsverhältnis oder Führungsposition: Niedergelassener Onkologe im Centrum für Hämatologie und Onkologie Bethanien Frankfurt. Direktor Onkologisches Centrum Frankfurt, Geschäftsführer der CHOP GmbH; Beratungs- bzw. Gutachtertätigkeit: Beratungstätigkeit u.a. Novartis, Roche, GSK, Seagan, Pfizer, Lilly, Astra Zeneca, Daiichi, Exact Science; Besitz von Geschäftsanteilen, Aktien oder Fonds: CHOP GmbH, VISION MED GmbH, Care and Coach GmbH, Onco Medical Consult GmbH; Honorare: Novartis, Roche, GSK, Seagan, Pfizer, Lilly, Astra Zeneca, Daiichi, Exact Science; Finanzierung wissenschaftlicher Untersuchungen: Lilly; Immaterielle Interessenkonflikte: Vorsitzender OncoNet Rhein-Main e.V. Rachel Wuerstlein: Agendia, Amgen, APOGHEVA, Aristo, Astra Zeneca, Clinsol, Daiichi-Sankyo, Eisai, Esteve, Exact Sciences, Gilead, Glaxo Smith Kline, Hexal, H+O Communication, Lilly, MSD, Mundipharma, Mylan, Nanostring, Novartis, Odonate, Onkowissen, Paxman, Pfizer, Pierre Fabre, PINK, , Riemser, Roche, Seagen, Sidekick, Stemline, streamedup, Tesaro Bio, Teva, Veracyte, Viatris, Wiley, Thieme; Institution: SPCC , WSG, AGO. Manfred Welslau: Beratungs- bzw. Gutachtertätigkeit: AMGEN, Bristol-Myers Squibb, Celgene, GILEAD, HEXAL, Janssen, Lilly, medac, NOVARTIS, Roche, SANOFI; Honorare: AMGEN, Astellas, AstraZeneca, Celgene, GILEAD, HEXAL, Janssen, Lilly, NOVARTIS, Rache, SANOFI. Susanne Briest: Honorar für Vorträge: AstraZeneca, Pierre Fabre, Novartis, Organon Healthcare, Daiichi Sankyo, Exact Sciences, Roche; Teilnahme an adboards: Pfizer, Seagan, MSD, Novartis, Organon Healthcare; Reiseunterstützung: Pierre Fabre, Daiichi Sankyo. Dörthe Holdhof: Employment AstraZeneca. Paul Kaschutnig: Employment Daiihi Sankyo. Marcus Schmidt: M. Schmidt reports personal fees from AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, GILEAD, Lilly, Molecular Health, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, and SeaGen; His institution has received research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre, and SeaGen. In addition, he has a patent for EP 2390370 B1 and a patent for EP 2951317 B1 issued. This study was funded by AstraZeneca. In March 2019, AstraZeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (T-DXd; DS-8201).

Publication History

Article published online:
04 June 2025