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Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy

NCT06680596 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-22

No results posted yet for this study

Summary

After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the efficacy of trastuzumab deruxtecan in terms of progression-free survival (PFS).

Conditions

  • Breast Cancer Metastatic
  • Breast Cancer Stage IV

Interventions

DRUG

trastuzumab derxutecan

T-DXd will be administrated as an intra-venous injection of 5.4 mg/kg every three weeks (1 cycle = 21-day treatment).

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • UNICANCER

    lead OTHER

Principal Investigators

  • Fabrice ANDRE, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2028-08-01
Completion
2029-08-01

Countries

  • France

Study Locations

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Entities

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 NCT06680596 on ClinicalTrials.gov