A prospective, non-interventional study (NIS) with trastuzumab deruxtecan for patients with HER2-low expressing unresectable and/or metastatic breast cancer accompanied by a disease registry of patients treated with conventional chemotherapy (DESTINY Breast Respond HER2-low Europe)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000277
• EU PAS number:
  EUPAS1000000277
• Study ID:
  1000000277
• Official title and acronym:
  A prospective, non-interventional study (NIS) with trastuzumab deruxtecan for patients with HER2-low expressing unresectable and/or metastatic breast cancer accompanied by a disease registry of patients treated with conventional chemotherapy (DESTINY Breast Respond HER2-low Europe)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  France

  Italy

  Netherlands

  Norway

  Portugal

  Spain

  Sweden

  Switzerland
• Study description:
  This non-interventional study will investigate the effectiveness of T-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of Adverse Drug Reactions (ADRs), and patient experience of T-DXd, in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC).; In addition, data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will be collected in a disease registry part of the study. The same inclusion criteria will be applied to patients on conventional chemotherapy. The disease registry part will allow us to understand treatment patterns and outcomes on conventional chemotherapy before the introduction of T-DXd in this patient setting.
• Study status:
  Ongoing

Research institution and networks

Institutions

Clinical, Regulatory and Safety, Cerner Enviza

Germany

Study timelines

Date when funding contract was signed

Planned: 06/06/2023

Actual: 06/06/2023

Study start date

Planned: 31/03/2024

Actual: 26/01/2024

Date of final study report

Planned: 31/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Daiichi Sankyo Europe GmbH

Study protocol

Initial protocol

DB-RespondHER2low_ShortSynopsis_V2_0_FINAL_20240429_clean.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

NCT05945732

Link to clinicaltrials.gov