NCT05945732 DESTINY Breast Respond HER2-(Ultra)Low Europe
| NCT ID | NCT05945732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company |
| Condition | Unresectable Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,295 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,295 participants in total. It began in 2023-10-24 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
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.
Contact & Investigator
Global Team Leader
STUDY DIRECTOR
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Frequently Asked Questions
Who can join the NCT05945732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unresectable Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05945732 currently recruiting?
Yes, NCT05945732 is actively recruiting participants. Contact the research team at CTRinfo@dsi.com for enrollment information.
Where is the NCT05945732 trial being conducted?
This trial is being conducted at Graz, Austria, Graz, Austria, Innsbruck, Austria, Klagenfurt, Austria and 11 additional locations.
Who is sponsoring the NCT05945732 clinical trial?
NCT05945732 is sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company. The principal investigator is Global Team Leader at Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company. The trial plans to enroll 2,295 participants.
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