This investigator-initiated, single-center, randomized, open-label, phase II trial will evaluate the efficacy and safety of intensified adjuvant SHR-A1811 compared with trastuzumab plus pertuzumab in women with initially stage IIB-IIIC HER2-positive early breast cancer who achieved pathologic complete response after neoadjuvant systemic therapy and have detectable postoperative circulating tumor DNA (ctDNA). Eligible participants will be randomized 1:1 and stratified by hormone receptor status, HER2 test category, and initial clinical anatomic stage. The primary endpoint is invasive disease-free survival.
Written informed consent before any study-specific procedure and willingness to comply with study visits and sample collection.
Female, aged 18 years or older.
Histologically confirmed invasive breast carcinoma at initial diagnosis, without distant metastasis.
HER2-positive tumor at initial diagnosis, defined as IHC 3+ or IHC 2+ with ISH amplification; hormone receptor status must be known.
Clinical, radiographic, or pathologic evidence of unresectable locally advanced, recurrent, or metastatic disease, or disease progression during neoadjuvant therapy.
Failure to achieve ypT0/is ypN0 or any residual invasive carcinoma in the breast or regional lymph nodes.
Prior ipsilateral or contralateral breast cancer, including ductal carcinoma in situ; lobular carcinoma in situ is permitted.
Any postoperative systemic anticancer therapy before randomization, including trastuzumab, pertuzumab, another anti-HER2 agent, chemotherapy, antibody-drug conjugate, or endocrine therapy; bridging therapy is not permitted.
Parallel
SHR-A1811
Drug4.8 mg/kg by intravenous infusion once every 3 weeks for 14 cycles.
Trastuzumab
DrugLoading dose: 8 mg/kg IV. Maintenance dose: 6 mg/kg IV Q3W.
Pertuzumab
DrugLoading dose: 840 mg IV. Maintenance dose: 420 mg IV Q3W.
Invasive Disease-Free Survival (IDFS)
IDFS is defined as the time from randomization to the first occurrence of ipsilateral invasive breast tumor recurrence, regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, secondary invasive primary cancer (nonbreast), or death from any cause.
Distant Disease-Free Survival (DDFS)
DDFS is defined as the time from randomization to the first occurrence of distant recurrence, secondary invasive primary cancer (nonbreast), or death from any cause.
Overall Survival (OS)
Time from randomization to death from any cause.
Brain Metastasis-Free Interval (BMFI)
Time from randomization to brain metastasis
Treatment-Emergent Adverse Events
Number and percentage of participants with treatment-emergent adverse events and serious adverse events, graded according to NCI CTCAE version 5.0.
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