Abstract 262TiP
Background
The treatment of HER2-positive (HER2+) tumors is continuously improving through the development of new anti-HER2-directed agents. The HER2-directed antibody-drug conjugate (ADC) trastuzumab deruxtecan (T-DXd) was authorized in the EU in 01/2021 for HER2+ mBC in the third-line (3L) setting. Approval was extended to 2L treatment in 07/2022 with T-DXd now being the new standard in 2L mBC based on the DESTINY-Breast03 study. In 01/2023, T-DXd was also approved for the treatment of mBC with HER2-low expression in patients who have received prior chemotherapy based on the DESTINY-Breast04 study.
Trial design
PROVIDENCE (NCT05573893) is a German, multicenter (approx. 150 sites planned), prospective, non-interventional study to evaluate real-world effectiveness, health-related quality of life (HRQoL), treatment patterns, and safety in pts with HER2+ and HER2-low mBC treated with T-DXd. Pts with HER2+ mBC must have received one prior anti-HER2-based regimen, i.e., they are eligible if they receive T-DXd in 2L. Pts with HER2-low mBC must have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy according to label. Informing the pts about digital health applications (DiGAs) is a prerequisite. The primary endpoint is time to next treatment 1 (TTNT1). Secondary endpoints are changes in HRQoL at 6 months based on the Functional Assessment of Cancer Therapy–Breast (FACT-B) and FACT-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 treatment patterns. Endpoints will be analyzed separately for the HER2+ and the HER2-low cohort. Moreover, the use of DiGAs will be described. Per cohort, 400 pts are planned. Pts are followed up for up to 5 years. First-patient-in was on 12 Sept 2023. Primary completion date is estimated for Q4 2030.
Clinical trial identification
NCT05573893.
Editorial acknowledgement
Medical writing assistance was provided by Yvonne Holighaus, Alcedis GmbH, Gießen, and was funded by AstraZeneca. The authors retained full control of the content and made the final decisions for all aspects of this abstract.
Legal entity responsible for the study
AstraZeneca In March 2019, AstraZeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (T-DXd; DS-8201).
Funding
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).
Disclosure
M.K. Welslau: Financial Interests, Personal, Advisory Board: Amgen, Bristol Myers Squibb, Celgene, Gilead, HEXAL, Janssen, Lilly, Medac, Novartis, Roche, Sanofi; Financial Interests, Personal, Other, Honoraria: Amgen, Astellas, AstraZeneca, Celgen, Gilead, HEXAL, Janssen, Lilly, Novartis, Roche, Sanofi. M. Schmidt: Financial Interests, Personal, Advisory Board: AstraZeneca, BioNTech, Daiichi Sankyo, Gilead, Eisai, Lilly, Molecular Health, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, Seagen; Financial Interests, Institutional, Funding, research funding: AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre, Seagen. R. Würstlein: Financial Interests, Personal, Advisory Board: Agendia, Amgen, Apogheva, AstraZeneca, Daiichi Sankyo, Exact Sciences, Gilead, Lilly, MSD, Nanostring, Novartis, Pfizer, Pierre Fabre, Riemser, Roche, Sanofi Genzyme, Seagen, Stemline, Clinsol; Financial Interests, Personal, Invited Speaker: Aristo, Clovis Oncology, Eisai, Hexal, Palleos, PINK, FOMF, Aurikamed, Pomme Med, Medconcept, MCI; Financial Interests, Institutional, Funding: Lilly; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Invited Speaker: WSG, PINK, BKFZ; Non-Financial Interests, Advisory Role: PINK, Brustkrebs Deutschland e.V., Junge Erwachsene Mit Krebs, AGO Kommission Mamma, AGSMO, DKG, TZM, CCC München, Mammamia. S. Briest: Financial Interests, Personal, Invited Speaker: AstraZeneca, Pierre Fabre, Novartis, Organon Healthcare, Daiichi Sankyo, Exact Science, Roche; Financial Interests, Personal, Advisory Board: Pfizer, Seagen, MSD, Novartis, Organon Healthcare; Financial Interests, Personal, Other, Travel: Pierre Fabre, Daiichi Sankyo. D. Holdhof: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. B. Edlich: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo. H. Tesch: Financial Interests, Personal, Advisory Board: Novartis, Roche, GSK, Seagen, Pfizer, Lilly, AstraZeneca, Daiichi Sankyo, Exact Science; Financial Interests, Personal, Stocks/Shares: CHOP GmbH, VIOSION MED GmbH, Care and Coach GmbH, Onco Medical Consult GmbH; Financial Interests, Institutional, Sponsor/Funding: Lilly; Non-Financial Interests, Personal, Member: OncoNet Rhein-Main e.V.