Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 14, 2023

Primary Completion Date

February 16, 2028

Study Completion Date

November 1, 2028

Conditions
Early-stage Breast CancerHER2-positive Breast CancerAdjuvant Treatment After TrastuzumabRCB Classification 1-2Neratini
Interventions
DRUG

Trastuzumab and neratinib

Trastuzumab (8 mg/kg IV loading dose, followed by 6 mg/kg IV once every 3 weeks), and neratinib 240 mg orally once daily. The trastuzumab treatment will be continued for a total of 18 cycles, encompassing both the preoperative and adjuvant phases, while neratinib will be maintained throughout the adjuvant period.

DRUG

Trastuzumab and Pertuzumab

Trastuzumab (8 mg/kg IV loading dose, followed by 6 mg/kg IV once every 3 weeks), and pertuzumab (840 mg IV loading dose, followed by 420 mg IV once every 3 weeks). This regimen will be repeated for a total of 18 cycles,encompassing both the preoperative and adjuvant phases.

Trial Locations (1)

Unknown

RECRUITING

Sun Yat-sen University Sun Yat-sen Memorial Hospital, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER