NCT01669239

Study of Neoadjuvant Myocet®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer

OptiHER-Heart: A Prospective, Multicenter, Single-arm, Phase II Study to Evaluate the Safety of Neoadjuvant Liposomal Doxorubicin (Myocet®) Plus Paclitaxel, Trastuzumab, and Pertuzumab in Patients With HER2-positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: SOLTI Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients with HER2-positive breast cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Doxorubicin	Six cycles of: * Trastuzumab 4 mg/kg loading dose on Day 1 of the first cycle, then 2 mg/kg on Days 8 and 15 of the first cycle and on Days 1, 8, and 15 of the subsequent cycles, every 3 weeks * Pertuzumab 840 mg loading dose on Day 1 of the first cycle, then 420 mg on Day 1, every 3 weeks * Liposomal doxorubicin 50 mg/m2 on Day 1, every 3 weeks * Paclitaxel 80 mg/m2 on Days 1, 8, and 15, every 3 weeks

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-08-20
• Last updated: 2017-11-06

Locations

19 sites across 1 country: Spain