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

Sponsor
AstraZeneca
Study ID
NCT06429761
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 2, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Trastuzumab deruxtecan

Primary Outcome Measure

To assess the safety of trastuzumab deruxtecan in adult Indian patients [ Time Frame: 6 Months ]

Central Contacts

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