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Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management

NCT07371585 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-27

No results posted yet for this study

Summary

This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD/pneumonitis.

Conditions

  • Breast Cancer Stage IV

Interventions

DEVICE

Digital Health Tools

Patients will be followed via digital health tools for proactive toxicity management, which consist of one mobile app and two devices: (1) CANKADO/Resilience app (depending on the country and site) accessed through the patient's phone; (2) A pulse oximeter that together with the digital health mobile app will allow self-tracking of vital parameters such as oxygen saturation and heart rate, potentially facilitating early ILD detection; and (3) A smartwatch to collect patient granular data. All three digital health tools/items are CE-marked medical devices, where relevant, used exclusively within their approved intended purpose, and not subject to any investigation of safety or performance within this study.

DRUG

T-DXd

T-DXd at 5.4 mg/kg will be administered as IV infusion q3w.

DRUG

Pertuzumab

Pertuzumab will be administered at a loading dose of 840 mg on Day 1 of Cycle 1, followed by 420 mg in subsequent cycles, administered as IV q3w.

Sponsors & Collaborators

  • Westdeutsche Studiengruppe GmbH (WSG)

    collaborator UNKNOWN

  • UNICANCER

    collaborator OTHER

  • SOLTI Breast Cancer Research Group

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-18
Primary Completion
2029-08-01
Completion
2030-07-01

Countries

  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT07371585 on ClinicalTrials.gov