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

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.

Trial Details

NCT ID

NCT07371585

Phase

PHASE2

Sponsor

SOLTI Breast Cancer Research Group

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Digital Health Tools
T-DXd
Pertuzumab

Locations (sample)

Villejuif, France|48.7939,2.35992
München, Germany|51.60698,13.31243
Barcelona, Barcelona, Spain|41.38879,2.15899
A Coruña, Spain|43.37135,-8.396
Alicante, Spain|38.34517,-0.48149

Key Eligibility Criteria

Able to understand the nature of the study and to voluntarily provide written informed consent prior to any trial-specific screening procedures and…
Male/female patients who are at least 18 years of age on the day of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Histologically or cytologically locally confirmed HR+/HER2+ or HR-/HER2+ BC with evidence of locally advanced disease, not amenable to resection or…

For full eligibility, visit ClinicalTrials.gov.

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