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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,039
Trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks)
Pertuzumab (loading dose 840 mg, followed by 420 mg every 3 weeks)
Chemotherapy chosen by the investigators.
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
Time frame: At surgery
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.
Time frame: Before surgery
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).
Time frame: At surgery
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).
Time frame: Assessed every 2 cycles of neoadjuvant therapy prior to surgery, up to approximately 30 days after the last neoadjuvant treatment.
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.
Time frame: Up to approximately 2 years from study enrollment
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Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.