NCT06429761

Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients

Aprospective, Multi Center Phase 4 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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

As per recommendation from DCGI, the current phase-IV study is planned with an aim to assess the safety of Trastuzumab deruxtecan in Indian subjects receiving the drug as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. The data obtained from the present study will help to understand the safety profile of Trastuzumab deruxtecan among Indian patients.

Conditions

• BREAST CANCER

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	IV infusion Trastuzumab deruxtecan will be administered at 5.4 mg/kg on day 1 of a 21 day cycle for 9 cycles.

Timeline

• Start date: 2025-01-02
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-05-28
• Last updated: 2025-11-24

Locations

6 sites across 1 country: India