Randomized Controlled Clinical Study of Efficacy and Safety of Initumab Combined with Pyrrotinib and Chemotherapeutic Agents in Neoadjuvant Therapy for HER2-positive Breast Cancer with Different Treatment Cycles

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

February 19, 2026

Study Completion Date

February 19, 2027

Conditions
HER2 Positive Breast Cancer
Interventions
DRUG

Cohort A will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses

Cohort A will receive initumab at initial load dose of 8mg/kg and maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 4 doses. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 4 cycles of administration

DRUG

Cohort B will receive an initial load dose of 8mg/kg and a maintenance dose of 6mg/kg intravenously on the first day of every three weeks for a total of 6 doses

The initial loading dose of initumab was 8mg/kg, and the maintenance dose was 6mg/kg, which was administered intravenously on the first day of every three weeks. Pyrrotinib 400mg orally once daily; Combined chemotherapy drugs (not limited, according to the actual clinical selection), a total of 6 cycles of administration

All Listed Sponsors
lead

The First Hospital of Jilin University

OTHER