This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas patients with a suboptimal response transition to an intensified investigational regimen incorporating novel targeted agents. This adaptive approach aims to optimize pathologic response, minimize unnecessary toxicity, and explore more effective treatment options for individuals with insufficient benefit from conventional neoadjuvant therapy.
Age ≥18 and ≤75 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Primary tumor size >1 cm.
Stage I (T1cN0M0)
Prior anti-tumor therapy for breast cancer, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.
Concurrent administration of any other anti-tumor treatment.
Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
Breast cancer not confirmed histologically.
Sequential
Nab paclitaxel
DrugNab paclitaxel
Carboplatin
Drugcarboplatin
Trastuzumab
Drugtrastuzumab
Pertuzumab
Drugpertuzumab
SHR-A1811
Druga HER2-targeted antibody-drug conjugate (ADC)
Pyrotinib
DrugPyrotinib: an oral irreversible pan-HER tyrosine kinase inhibitor (TKI).
Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0
The tpCR rate is defined as the proportion of participants with no residual invasive cancer cells in both the breast primary tumor site (residual in situ cancer cells are permitted) and all sampled axillary lymph nodes.
Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis
The bpCR rate is defined as the proportion of participants with no residual invasive cancer cells in the breast primary tumor site (residual in situ cancer cells are permitted).
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a complete or partial response.
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: precludes surgery, local or distant recurrence, second primary malignancy, or death due to any cause.
Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product, temporally associated with study intervention, without presumption of causality.
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