AstraZeneca is conducting a prospective, multicenter, single-arm Phase 4 trial evaluating the safety profile of trastuzumab deruxtecan (T-DXd) specifically in Indian patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti-HER2–based regimen. The trial is currently active but no longer enrolling.
AstraZeneca has initiated a Phase 4 post-marketing safety assessment of trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate (ADC) targeting HER2, in a population not extensively represented in earlier pivotal trials: Indian patients with unresectable or metastatic HER2-positive breast cancer. The prospective, multicenter, single-arm study (NCT06429761) is currently active but has closed to new enrollment.
T-DXd couples a HER2-directed monoclonal antibody with a topoisomerase I inhibitor payload (deruxtecan), delivering cytotoxic activity preferentially to HER2-overexpressing tumor cells. The drug has demonstrated robust efficacy in global registrational trials such as DESTINY-Breast03, but real-world safety data in South Asian populations—who may differ in pharmacogenomic profiles, comorbidity burden, and prior treatment exposure—remain limited.
Eligibility requires prior receipt of at least one anti-HER2–based regimen, positioning this cohort in the second-line or later metastatic setting. The primary focus on safety endpoints—rather than efficacy—reflects a regulatory and pharmacovigilance imperative to characterize adverse event patterns, including interstitial lung disease (ILD) and hematologic toxicity, in this geographically distinct patient group. Findings may inform local prescribing guidance and risk-management strategies for oncologists practicing in India.
Key points
- Phase 4 single-arm trial assessing T-DXd safety specifically in Indian patients with unresectable or metastatic HER2-positive breast cancer
- Enrollment is closed; the trial remains in active follow-up phase
- Eligible participants must have received at least one prior anti-HER2–based regimen
- Primary objective is safety characterization, including adverse events such as ILD, in a South Asian population underrepresented in global pivotal trials
- Sponsored by AstraZeneca; registered on ClinicalTrials.gov as NCT06429761
Why it matters
Population-specific safety data for T-DXd are critical given that adverse event profiles—particularly ILD incidence and severity—may vary across ethnic groups, and Indian oncologists currently rely on extrapolated data from predominantly Western and East Asian trial cohorts. This trial may directly shape regional prescribing and monitoring protocols.