NCT06680596

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

A ctDNA Screening Program in Patients With HR+, HER2 Low Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor Followed by a Single Arm Phase II Trial of Trastuzumab-deruxtecan in Patients With Persistent ctDNA After 1 Month of Treatment With Endocrine Therapy Combined With CDK4/6 Inhibitor

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Eligible patients to the screening phase are patients with hormone receptor positive (estrogen receptor and/or progesterone receptor \>10%) and HER2 low or ultralow metastatic breast cancer who will receive standard first line therapy with CDK4-6i (any from the market), combined with aromatase inhibitor or fulvestrant. Patient persistence of tumor DNA in the blood at 4 weeks of this standard therapy will be included in the treatment phase with trastuzumab deruxtecan (T-DXd).

Conditions

• Breast Cancer Metastatic
• Breast Cancer Stage IV

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-07-30
• Primary completion: 2028-08-01
• Completion: 2029-08-01
• First posted: 2024-11-08
• Last updated: 2025-09-22

Locations

34 sites across 1 country: France