Clinical Trial: NCT06429761
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 4| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-09-11 |
Study Overview
Brief 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
Official Title
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
Conditions
BREAST CANCER
Intervention / Treatment
- Drug: Trastuzumab deruxtecan
Other Study ID Numbers
- D9673L00012
Start Date (Actual)
2025-01-02
Primary Completion Date (Estimated)
2026-10-31
Study Completion Date (Estimated)
2026-10-31
Enrollment (Actual)
100
Study Type
Interventional
Phase
Phase 4
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-09-11 |
Study Overview
Brief 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
Official Title
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
Conditions
BREAST CANCER
Intervention / Treatment
- Drug: Trastuzumab deruxtecan
Other Study ID Numbers
- D9673L00012
Start Date (Actual)
2025-01-02
Primary Completion Date (Estimated)
2026-10-31
Study Completion Date (Estimated)
2026-10-31
Enrollment (Actual)
100
Study Type
Interventional
Phase
Phase 4