This study will evaluate the safety and efficacy of neoadjuvant trastuzumab, pertuzumab and chemotherapy chosen by the investigators and identify the molecular characterization and subtypes in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Age 18 - 75 years;
Eastern Cooperative Oncology Group (ECOG) score status 0-1.
Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0);
HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization;
Patients with stage IV metastatic breast cancer.
Bilateral invasive breast cancer;
Patients with breast cancer who have previously received anti-tumor therapy.
Occurred or present with other malignant tumors within 5 years. Patients with the following two conditions can be enrolled: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)];
Single group
Trastuzumab
DrugTrastuzumab (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks)
Pertuzumab
DrugPertuzumab (loading dose 840 mg, followed by 420 mg every 3 weeks)
Chemotherapy
DrugChemotherapy chosen by the investigators.
Excision of tumor/mastectomy
Procedure/SurgeryDefinitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.
Total pathological complete response (tpCR) rate
The pathological complete response rate described as the absence of invasive tumor cells in the breast and ipsilateral axillary lymph nodes upon microscopic examination following
Objective Response Rate (ORR)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Breast pathological complete response (bPCR) rate
It is defined as no invasive tumor cells in the breast examined by microscopy after primary tumor resection (ypT0/is).
Number of participants with adverse events (AEs)
Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).
Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes.
Tumor tissue samples are analyzed by gene expression analysis and genome sequencing to classify novel subtypes and compare the molecular characteristics with patients' clinical data.
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