At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating 5-Fluorouracil, Cyclophosphamide, and 6 other interventions for Breast Cancer. Completed, enrolled 401 participants across 80 sites in 12 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Participants will receive 5-fluorouracil 500 mg/m\^2 IV on Day 1 of each cycle q3w.
Participants will receive cyclophosphamide 600 milligrams per square meter (mg/m\^2) intravenous (IV) given on Day 1 of each cycle q2w.
Participants will receive docetaxel at a starting dose of 75 mg/m\^2 IV for the first cycle and the dose may be escalated to 100 mg/m\^2 for subsequent cycles q3w.
Participants will receive doxorubicin 60 mg/m\^2 IV on Day 1 of each cycle q2w.
Participants will receive epirubicin 100 mg/m\^2 IV on Day 1 of each cycle q3w.
Participants will receive paclitaxel 80 mg/m\^2 IV given weekly.
Participants will receive pertuzumab at a loading dose of 840 milligrams (mg) IV loading dose, then 420 mg IV q3w.
Participants will receive trastuzumab at a loading dose of 8 milligrams per kilogram (mg/kg) IV, then 6 mg/kg IV q3w.