NCT01597414

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

Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Elderly Metastatic Breast Cancer Population

Interventions

Type	Name	Description
DRUG	Pertuzumab + trastuzumab	Trastuzumab: loading dose of 8 mg/kg of body weight on cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks. Pertuzumab: loading dose of 840 mg on cycle 1, followed by 420 mg for subsequent cycles, every 3 weeks. if T-DM1: 3.6 mg/kg IV, every 3 weeks.
DRUG	Pertuzumab + trastuzumab + metronomic chemotherapy	Pertuzumab and trastuzumab will be administered as in arm A. Cyclophosphamide: daily dose of 50 mg/day. if T-DM1: as in arm A

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-03-01
• Completion: 2022-11-01
• First posted: 2012-05-14
• Last updated: 2022-11-17

Locations

30 sites across 8 countries: Belgium, France, Italy, Netherlands, Poland, Portugal, Sweden, United Kingdom