DESTINY Breast Respond HER2-low Europe

Recruiting

• Conditions: Metastatic Breast Cancer; HER2-low Expressing Breast Cancer; Unresectable Breast Cancer
• Interventions: Drug: Trastuzumab deruxtecan

• Registration Number: NCT05945732
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Brief Summary

Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Detailed Description

This non-interventional study will investigate the effectiveness withT-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). No drug product will be administered as part of this study.

Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.

Study Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Study Start: 2023-10-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-24
• Primary Completion: 2027-06-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

• Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
• Documented HER2-low status (IHC1+, IHC2+/ISH-)
• Patients who have received prior chemotherapy in the metastatic setting or patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
• Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
• Written and signed Informed Consent to participate in the study

Exclusion Criteria

• Pregnancy or breastfeeding
• Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.

No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trastuzumab deruxtecan (T-DXd)	Trastuzumab deruxtecan	Participants with HER2-low expressing unresectable and/or metastatic breast cancer who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional chemotherapy. The participants on conventional chemotherapy will be analyzed exploratory only.

Primary Outcome Measures

Name	Time	Method
Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer	Baseline up to 31 months

Secondary Outcome Measures

Name	Time	Method
Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer	Baseline up to 31 months
Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer	Baseline up to 31 months
Number of Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only)	Baseline up to 31 months
Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only)	Baseline up to 31 months
Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer	Baseline up to 31 months	The PGI-TT is designed to assess the treatment tolerability of the medicine. Participants will rate the bother associated with any treatment-related symptoms based on a 5-point scale ranging from 1 (not at all) to 5 (very much). Higher scores indicate a worse outcome.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer	Baseline up to 31 months	The EORTC QLQ-C30 questionnaire is designed to measure cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary	Baseline up to 31 months

Trial Locations

Locations (197)

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria

Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt am Wörthersee, Austria

LKH Hochsteiermark-Leoben; 🇦🇹 Leoben, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern; 🇦🇹 Linz, Austria

Interne II, LKH Feldkirch; 🇦🇹 Rankweil, Austria

KH der Barmherzigen Brüder Salzburg; 🇦🇹 Salzburg, Austria

Uniklinikum Salzburg; 🇦🇹 Salzburg, Austria

Salzkammergut Klinikum Vöcklabruck; 🇦🇹 Vöcklabruck, Austria

Klinikum Wels-Grieskirchen GmbH; 🇦🇹 Wels, Austria

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