Clinical trial · Observational
TDXD in Metastatic HER2-Positive Breast Cancer
Study of Efficacy and Toxicity of Trastuzumab Deruxtecan in Metastatic HER2-Positive Breast Cancer Patients: Single Center Experience, Madinah, Saudi Arabia
NCT07778407CI-TRIAL-00123183completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A single-center observational study (retrospective + prospective) evaluating the real-world efficacy and toxicity profile of Trastuzumab Deruxtecan (T-DXd) in adult female patients with HER2-positive metastatic breast cancer treated at KSAMC, Madinah, Saudi Arabia
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 Advanced Malignancies | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab deruxtecan (T-DXd) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Disease Control Rate (DCR)
- timeFrame
- 2 years
- description
- proportion of patients achieving CR + PR + SD per RECIST 1.1
- measure
- PFS
- timeFrame
- 2 years
- description
- time from treatment initiation to progression or death
- measure
- OS
- timeFrame
- 2 years
- description
- time from treatment initiation to death from any cause
Secondary outcomes (1)
- measure
- Toxcicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥ 18 years * Histologically confirmed HER2-positive metastatic breast cancer * Progression during or within 6 months of finishing adjuvant anti-HER2 therapy (T-DXd as 2nd line), OR de novo metastatic disease previously treated with ≥ 2 lines of anti-HER2 therapy (T-DXd as 3rd line or beyond) * ECOG Performance Status 0-1 * LVEF ≥ 50% on echocardiography * Measurable lesions per RECIST v1.1 * Adequate hematologic, hepatic, and renal function Exclusion Criteria: * History of non-infectious interstitial lung disease (ILD) / pneumonitis requiring steroids * Active uncontrolled infection * Symptomatic/uncontrolled brain metastases * Severe cardiac dysfunction (LVEF \< 50%) * Pregnancy or lactation
References
Publications (1)
- RESULTAndre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20. PMID 37086745