| Description |
This is an Asia-Pacific regional, randomized, double-blind, Phase III, multicenter study to evaluate treatment with trastuzumab pertuzumab docetaxel compared with trastuzumab placebo docetaxel in patients who are chemotherapy-naive with early-stage HER2 positive breast cancer. A primary tumor with the longest diameter of within 2 cm is required. Following are the study objectives: To evaluate the efficacy of trastuzumab pertuzumab docetaxel compared with trastuzumab placebo docetaxel as neoadjuvant treatment prior to surgery in patients who are chemotherapy-naive with early stage or locally advanced HER2 positive breast cancer as measured by tpCR rate assessed by an Independent Review Committee (IRC). To evaluate the safety and tolerability of each treatment regimen. To explore relationships between findings from the sentinel lymph node (SLN) biopsy tissue samples (if biopsy is performed) and the axillary lymph node dissection (ALND) tissue sample from the surgery undertaken after neoadjuvant treatment.To characterize the pharmacokinetics of pertuzumab after intravenous (IV) infusion in a subset of Chinese patients with early-stage or locally advanced HER2-positive breast cancer.To analyze biomarkers in tumor tissue taken at baseline or at the time of resection (markers analyzed may include but are not limited to HER2/3 mRNA and/or protein, PIK3CA, phosphatase and tensin homolog, programmed death ligand and cluster of differentiation and serum and evaluate correlations with clinical outcomes and, if applicable, safety outcomes.To analyze the effect of HER2 ECD on pharmacokinetics of pertuzumab.To analyze the effect of nti-therapeutic antibodies (ATAs) on pharmacokinetics, safety, and efficacy.To assess tpCR about clinical response rate, EFS, DFS, and overall survival. |
