Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer

Sponsor
Henan Cancer Hospital
Study ID
NCT07416253
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab rezetecan — DRUG
    Participants will receive Trastuzumab-rezetecan for 8 cycles
  • Trastuzumab deruxtecan — DRUG
    Participants will receive Trastuzumab deruxtecan for 8 cycles

Study Details

This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles. After completing neoadjuvant treatment, patients will undergo definitive surgery, and tpCR will be assessed from resected specimens. Patients will then be followed up to monitor long-term efficacy (e.g., EFS) and late-onset adverse events. A total of 68 patients (34 per arm) will be enrolled to achieve the study's statistical objectives.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2030

Study Design

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

Arms

  • Experimental: trastuzumab-rezetecan group
  • Active Comparator: trastuzumab deruxtecan group

Primary Outcome Measure

Pathological Complete Response Rate [ Time Frame: 3 to 8 weeks after neoadjuvant treatment completion ]

Central Contacts

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