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Initumab + Pyrrotinib Neoadjuvant Therapy in HER2+ Breast Cancer
NCT06868017Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Apr 2025
- Primary completion
- Feb 2026
- Sponsor
- The First Hospital of Jilin University
- Modality
- Fragment-Derived Small Molecules, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- inetetamabpyrotinib
- Conditions
- HER2-positive breast cancer
01
Overview
Phase 4, randomised, open-label trial of inetetamab and pyrotinib in HER2-positive breast cancer (2 cohorts), sponsored by The First Hospital of Jilin University. Primary endpoint: total Pathological Complete Response. Planned start Apr 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Cohort A (4 Cycles)
4 cycles of neoadjuvant therapy followed by surgery and adjuvant therapy.
Cohort B (6 Cycles)
6 cycles of neoadjuvant therapy followed by surgery and adjuvant therapy.
03
Who it enrols
Patients with HER2-positive invasive breast cancer (T1c-4, N0-3, M0) aged 18-70 with adequate organ function. Excludes prior systemic breast cancer treatment, bilateral or inflammatory breast cancer, and T1cN0M0 tumors.
04
Endpoints
Primary
total Pathological Complete Response
Secondary
Overall Response Rate
Event-Free Survival
Invasive Disease-Free Survival
Overall Survival
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