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

NCT06429761 | Recruiting Phase 4

• 1 other identifier: D9673L00012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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

Conditions

BREAST CANCER

Outcome Measures

Primary Outcomes (1)

• To assess the safety of trastuzumab deruxtecan in adult Indian patients

  Rate of adverse events

  6 Months

Study Arms (1)

Single Arm

EXPERIMENTAL

Trastuzumab deruxtecan

Drug: Trastuzumab deruxtecan

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be \>18 years of age inclusive, at the time of signing the informed consent.
• 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.
• 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).
• 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
• × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline, and
• Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × ULN
• Adequate blood clotting function within 14 d before enrolment, defined as:
• International normalized ratio/prothrombin time ≤ 1.5 × ULN and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN 8 Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 mo after the last dose of trastuzumab deruxtecan. Male subjects must agree to inform all potential female partners that they are participating in a clinical trial of a drug that may cause birth defects. Male subjects must also agree to either avoid intercourse or that they and/or any female partners of reproductive/childbearing potential will use a highly effective form of contraception during and upon completion of the study and for at least 4.5 mo after the last dose of trastuzumab deruxtecan. Methods considered as highly effective methods of contraception include:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:

You may not qualify if:

• Prior treatment with T-DXd
• Uncontrolled or significant cardiovascular disease, including any of the following:
• History of myocardial infarction within 6 months before enrolment
• History of symptomatic congestive heart failure (New York Heart Association Class II to IV);
• Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male);
• LVEF \< 50% within 28 d prior to treatment initiation.
• 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.
• 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.
• Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product or to other mAbs.
• Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
• Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection.
• Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the investigator after consultation with the Sponsor Medical Monitor or designee (eg, Grade 2 chemotherapy-induced neuropathy).
• Therapeutic radiation therapy or major surgery within 4 wk before enrolment or palliative stereotactic radiation therapy within 2 wk before enrolment.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Bangalore, 560017, India

RECRUITING

Research Site

Delhi, 110029, India

RECRUITING

Research Site

Kochi, 682041, India

RECRUITING

Research Site

Mumbai, 400012, India

RECRUITING

Research Site

Pune, 411028, India

RECRUITING

Research Site

Varanasi, 221005, India

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

IN (6)