Recruiting NCT05945732

DESTINY Breast Respond HER2-(Ultra)Low Europe

— Observational Unresectable Breast Cancer Metastatic Breast Cancer HER2-low Expressing Breast Cancer HER2-(Ultra)Low Expressing Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Trastuzumab deruxtecan.
Who it may be relevant to: Registry conditions: Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Austria, Belgium, Denmark, France, Italy +5
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)Low Europe)

Overview

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. Based on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new patient population will be enrolled, comprising adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.

Detailed 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 and HER2-(ultra)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. For Study Group 2, only baseline data will be collected for patients treated with conventional chemotherapy.

Interventions

Drug Trastuzumab deruxtecan
This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice. Trastuzumab (T-DXd) to be administered according to the SmPC. Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC.

Primary outcome measures

Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer [Time frame: Baseline up to approximately 37 months]

Secondary outcome measures (7)

Type of Treatment Patterns in Participants With Unresectable and/or Metastatic Breast Cancer [Time frame: Baseline up to approximately 37 months]
Number of Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only) [Time frame: Baseline up to approximately 37 months]
Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only) [Time frame: Baseline up to approximately 37 months]
Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With Unresectable and/or Metastatic Breast Cancer [Time frame: Baseline up to approximately 37 months]
Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With Unresectable and/or Metastatic Breast Cancer [Time frame: Baseline up to approximately 37 months]
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With Unresectable and/or Metastatic Breast Cancer [Time frame: Baseline up to approximately 37 months]
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary [Time frame: Baseline up to approximately 37 months]

Eligibility criteria

Inclusion criteria

Study Group 1 and Study Group 2

Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
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

Study Group 1

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

Study Group 2:

Documented HR+ status
Documented HER2-low status (IHC1+ or IHC2+/ISH-) or HER2-ultralow (defined as IHC 0 with membrane staining \[IHC > 0 to <1+\]) status
Patients who have received at least one endocrine therapy in the metastatic setting
Patients who have NOT received prior chemotherapy in the metastatic setting

Exclusion criteria

Study Group 1 and Study Group 2

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 other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-control