Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer

Sponsor
Fudan University
Study ID
NCT07368543
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan — DRUG
    Recommended Dose: 10 mg/kg administered by intravenous infusion on Days 1 and 8 of each 21-day treatment cycle. Continue treatment until disease progression or unacceptable toxicity.
  • Trastuzumab Deruxtecan — DRUG
    Dosage and Administration: The recommended dose is 5.4 mg/kg administered by intravenous infusion once every 3 weeks (21-day cycles). Continue treatment until disease progression or unacceptable toxicity.

Study Details

Currently, no phase III RCT has directly compared SG and T-DXd sequencing strategies, and the predictive role of biomarkers remains unclear. Additionally, there is no standard scoring system for Trop-2 expression. The ASCENT trial utilized an H-score method (H-score = 3×%IHC3+ + 2×%IHC2+ + 1×%IHC1+), with scores \<100, 100-200, and \>200 defining low, medium, and high Trop-2 expression, respectively.This prospective study aims to: 1) Evaluate the efficacy of SG vs. T-DXd in HER2-low/Trop-2-high metastatic breast cancer, prioritizing SG for Trop-2-high patients and T-DXd for others. 2) Compare sequential treatment outcomes-T-DXd after SG failure versus SG after T-DXd failure-to inform ADC sequencing in HER2-low disease. Up to one intervening therapy is allowed before sequencing. 3) Identify biomarkers of ADC efficacy and resistance through quantitative protein analysis to optimize patient selection.

Key Dates

Start date
Jan 16, 2026
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (Triple-Negative Breast Cancer)
    Patients with HER2 IHC 1+ metastatic triple-negative breast cancer (TNBC);
  • Experimental: Cohort B (HR+/HER2 IHC 1+ and Ultralow Metastatic Breast Cancer)
    Patients with HR-positive/HER2 IHC 1+ and HER2 ultralow metastatic breast cancer (MBC) who have failed endocrine therapy.

Primary Outcome Measure

Progression-Free Survival 1 (PFS1) [ Time Frame: Until progression, assessed up to approximately 24 months ]

Central Contacts

Related Studies