RecruitingPhase 4NCT06429761

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


Sponsor

AstraZeneca

Enrollment

100 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a post-marketing safety study for a drug called trastuzumab deruxtecan (T-DXd) — a targeted therapy for HER2-positive metastatic breast cancer — being conducted in India. It is monitoring how well the drug works and what side effects it causes in Indian patients in real-world clinical practice. **You may be eligible if...** - You are over 18 years old - You have metastatic or unresectable breast cancer that tests positive for HER2 (IHC 3+ or IHC 2+ with gene amplification confirmed) - You have received at least one prior HER2-targeted treatment - You are able to give informed consent **You may NOT be eligible if...** - You have previously been treated with trastuzumab deruxtecan (T-DXd) - You have significant heart disease, including recent heart attack, heart failure, or reduced heart pumping function (LVEF below 50%) - You have had or currently have serious lung inflammation (interstitial lung disease or pneumonitis) - You have active, uncontrolled infections or certain other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab deruxtecan

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


Locations(6)

Research Site

Bangalore, India

Research Site

Delhi, India

Research Site

Kochi, India

Research Site

Mumbai, India

Research Site

Pune, India

Research Site

Varanasi, India

View Full Details on ClinicalTrials.gov

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NCT06429761


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