Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer following neoadjuvant therapy. Furthermore, there are no prospective randomized controlled trials comparing trastuzumab plus pertuzumab versus trastuzumab plus TKIs in HER2-positive breast cancer patients with residual cancer burden class (RCB) I or II after neoadjuvant trastuzumab and pertuzumab. Therefore, this study aimed to evaluate the efficacy and safety of adjuvant trastuzumab plus neratinib in patients with hormone receptor-positive/HER2-positive breast cancer and RCB 0/I following neoadjuvant trastuzumab and pertuzumab therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
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.
Sun Yat-sen University Sun Yat-sen Memorial Hospital
Guangzhou, China
RECRUITINGInvasive disease free survival, IDFS
The time from random assignment until the first occurrence of invasive disease recurrence, distant recurrence, or death from any cause.
Time frame: During the 3 years after random assignment
Disease free survival, DFS
The time from random assignment until recurrence, the development of a second cancer, or death from any cause.
Time frame: During the 3 years after random assignment
Overall survival, OS
The time from randomization to death from any cause.
Time frame: During the 3 years after random assignment
Distant disease free survival, DDFS
The time from random assignment until the first occurrence of distant recurrence or death from any cause.
Time frame: During the 3 years after random assignment
Incidence and severity of adverse events
The incidence and severity of adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Time frame: From signing the informed consent form until 28 days after completion of adjuvant treatment
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