Clinical trial · Observational
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
NCT06231693CI-TRIAL-00089434terminatedClinicalTrials.gov clinicaltrialsProvenance
- 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 study was stopped due to a realignment of strategic priorities
Summary
Brief summary (as posted)
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE\<10%) metastatic HER2-Low breast cancer.
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 |
|---|---|---|---|
| Trastuzumab deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Trastuzumab-deruxtecan
- interventionNames
- Drug: Trastuzumab deruxtecan
Primary outcomes (1)
- measure
- Time to Next Treatment
- timeFrame
- Through study completion, an average of 1 year
Secondary outcomes (4)
- measure
- Response Rate
- timeFrame
- Through study completion, an average of 18 months
- measure
- Real World Progression Free Survival
- timeFrame
- Through study completion, an average of 18 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged above 18 years old; * Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer; * Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line; * Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months. Exclusion Criteria: * Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms); * Have other active neoplasms (except from non-melanoma skin tumors); * Have serious or active non-oncology lung diseases; * Have other primary and concurrent breast tumor with differing receptor profiles.
References
Publications (0)
Data not yet available
No reference posted for this study.