DESTINY Breast Respond HER2-low Europe

Daiichi Sankyo

Status: Enrolling

Conditions: Unresectable Breast Cancer; HER2-low Expressing Breast Cancer; Metastatic Breast Cancer

Treatments: Drug: Trastuzumab deruxtecan

Study type: Observational

Funder types: Industry

Identifiers

NCT05945732

DS8201-0005-NIS-MA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,350 participants in 1 patient group

Trastuzumab deruxtecan (T-DXd)

Description:

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.

Treatment:

Drug: Trastuzumab deruxtecan