drugset / Trial / NCT01597414

Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1

NCT01597414

RandomizedParallel-groupOpen-labelTreatment

Summary

Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients. The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.

Timeline

Start
2013-06
Primary completion
2017-03
Completion
2022-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg Oral
Comparator Pertuzumab Monoclonal antibody 420 mg Intravenous
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Comparator Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous

Indications