drugset / Trial / NCT02625441

Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer

NCT02625441

Phase 3 Active not recruiting 516 enrolled Helsinki University Central Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized clinical trial compares two systemic treatments for HER2-positive breast cancer. The treatments are given either prior to breast surgery (as neoadjuvant treatment) or after breast surgery (as adjuvant treatment). In the investigational group (Group A) the study participants will receive a combination of two drugs directed at HER2 (two anti-HER2 antibodies) plus a chemotherapy agent (docetaxel) for a brief duration, and the patients allocated to the comparator group (Group B) will be treated with chemotherapy plus one anti-HER2 treatment (trastuzumab) for one year.

Timeline

Start
2015-12
Primary completion
2025-06-01
Completion
2025-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications