OncoMatch/Clinical Trials/NCT06429761
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
Is NCT06429761 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Trastuzumab deruxtecan for breast cancer.
Treatment: Trastuzumab deruxtecan — A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+ with ish positive)
Disease stage
Metastatic disease required
Prior therapy
Must have received: HER2-targeted therapy
was previously treated with an anti HER-2 based regimen
Cannot have received: antibody-drug conjugate (trastuzumab deruxtecan, T-DXd)
Prior treatment with T-DXd
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9/L (no G-CSF within 1 wk prior); Platelet count ≥ 100 × 10^9/L (no platelet transfusion within 1 wk prior); Hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 1 wk prior)
Kidney function
Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault equation)
Liver function
Total bilirubin ≤ 1.5 × ULN if no liver metastases or < 3 × ULN in the presence of documented Gilbert's syndrome or liver metastases; AST/ALT ≤ 3 × ULN
Cardiac function
No history of myocardial infarction within 6 months; no symptomatic congestive heart failure (NYHA II-IV); QTc ≤ 470 ms (females) or ≤ 450 ms (males); LVEF ≥ 50% within 28 days prior to treatment
Adequate bone marrow function... Adequate renal function... Adequate hepatic function... Adequate blood clotting function... Uncontrolled or significant cardiovascular disease, including any of the following: History of myocardial infarction within 6 months before enrolment, History of symptomatic congestive heart failure (NYHA II-IV); QTc prolongation to > 470 ms (females) or >450 ms (male); LVEF < 50% within 28 d prior to treatment initiation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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