Clinical trial · Observational
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The DESTINY-Breast RESPOND study was terminated early due to start-up delays and slow enrolment, despite extensive mitigation. Operational challenges alone prevent study continuation and were not related to any product or patient safety concerns.
Summary
Brief summary (as posted)
This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) \[globally\] or HER2-low \[North America only\] in routine clinical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| None (Observational Study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HER2+ Cohort
- description
- Patients with HER2+ unresectable and/or mBC who are prescribed T-DXd and have received a prior anti-HER2 based regimen.
- interventionNames
- Other: None (Observational Study)
- label
- HER2-low cohort
- description
- Patients with HER2-low unresectable and/or mBC who are prescribed T-DXd and have received a prior chemotherapy.
- interventionNames
- Other: None (Observational Study)
Primary outcomes (2)
- measure
- Real-World Time to Next Treatment (rwTTNT)
- timeFrame
- From first dose of T-DXd until study discontinuation (approximately 3 years)
- description
- Real-world time to next treatment will be evaluated. rwTTNT is defined as the length of time from date of first T-Dxd administration to the date the patient received an administration of their next systemic treatment regimen or to their date of death if there is a death prior to having another systemic treatment regimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥18 years of age at time of consent. * Histological or cytological confirmed diagnosis of unresectable and/or mBC. * Documented HER2 status via a validated method. * Adult patients with unresectable or metastatic HER2+ breast cancer who have received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing therapy. Or Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. * Decision to newly initiate monotherapy T-DXd per standard of care. * Capable of providing informed consent and completing questionnaires. Exclusion Criteria: * Pregnancy or breastfeeding. * History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis. * Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
References
Publications (0)
Data not yet available