Available IPD datapackage for study '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.