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RECRUITINGPHASE4

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

NCT06429761•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1 Participant must be \>18 years of age inclusive, at the time of signing the informed consent.
•2 Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•3 Participants with pathologically documented breast cancer that:
•is unresectable or metastatic
•HER2-positive expression (IHC 3+ or IHC 2+ with ISH positive) as confirmed by laboratory assessment within last 1 year of study enrolment.
•was previously treated with an anti HER-2 based regimen 4 Adequate bone marrow function, within 14 d before enrolment, defined as:
•a. Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony-stimulating factor administration is not allowed within 1 wk prior to Screening assessment); b. Platelet count ≥ 100 × 109/L (Platelet transfusion is not allowed within 1 wk prior to Screening assessment); c. Hemoglobin level ≥ 9.0 g/dL (Red blood cell transfusion is not allowed within 1 wk prior to Screening assessment).
•5 Adequate renal function within 14 d before enrolment, defined as:
•Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation (CLcr (mL/min) = \[140 - age (years)\] × weight (kg) {× 0.85 for females}; 72 × serum creatinine (mg/dL) 6 Adequate hepatic function within 14 d before enrolment, defined as:
•Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or \< 3
+20 more criteria

Exclusion Criteria

•1. Prior treatment with T-DXd
•2. Uncontrolled or significant cardiovascular disease, including any of the following:
•1. History of myocardial infarction within 6 months before enrolment
•2. History of symptomatic congestive heart failure (New York Heart Association Class II to IV);
•3. Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male);
•4. LVEF \< 50% within 28 d prior to treatment initiation.
•3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
•4. Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
•* Subjects with clinically inactive brain metastases may be included in the study.
•* Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 wk must have elapsed between the end of whole brain radiotherapy and study enrollment.
+9 more criteria

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

Key Dates

Start Date

January 2, 2025

Primary Completion Date

October 31, 2026

Completion Date

October 31, 2026

Last Updated

November 24, 2025

Enrollment

100

ESTIMATED participants

Conditions

BREAST CANCER

Interventions

Trastuzumab deruxtecan

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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