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TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

NCT06533826 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2025-10-24

No results posted yet for this study

Summary

The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer.

The names of the study drugs involved in this study are:

* Datopotamab deruxtecan (a type of antibody drug conjugate)
* Trastuzumab deruxtecan (a type of antibody drug conjugate)

Conditions

Interventions

DRUG

Trastuzumab Deruxtecan

A HER2-directed ADC, 100mg/vial, via intravenous (into the vein) infusion per protocol.

DRUG

Datopotamab Deruxtecan

A TROP2-directed antibody drug conjugate, 100mg/vial, via intravenous (into the vein) infusion per protocol.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Ana C Garrido-Castro, MD

    lead OTHER

Principal Investigators

  • Ana Garrido-Castro, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2028-01-01
Completion
2038-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06533826 on ClinicalTrials.gov