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.

Publication History

Article published online:
04 June 2025