A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer

This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the
safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and
anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive
locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a
treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for
Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by
paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment
regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC),
followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel.
Participants in both cohorts will subsequently undergo surgical treatment and then resume
pertuzumab and trastuzumab treatment.

本项多中心、非随机、开放标签的II期临床研究，旨在评估帕妥珠单抗（pertuzumab，Perjeta）联合曲妥珠单抗（trastuzumab，Herceptin）及蒽环类药物为基础的化疗，作为HER2阳性局部晚期、炎性或早期乳腺癌受试者的新辅助治疗方案的安全性与有效性。每位研究者将为其所有入组受试者选定统一的治疗方案（方案A或方案B）进行治疗。方案A（对应队列A）为先予剂量密集型阿霉素联合环磷酰胺（ddAC），后续予以紫杉醇治疗，且自紫杉醇治疗起始日起联合给予帕妥珠单抗与曲妥珠单抗。方案B（对应队列B）为先予5-氟尿嘧啶、表阿霉素联合环磷酰胺（FEC），后续予以多西他赛治疗，且自多西他赛治疗起始日起联合给予帕妥珠单抗与曲妥珠单抗。两个队列的受试者后续均将接受外科手术治疗，随后恢复帕妥珠单抗与曲妥珠单抗的治疗。