NCT01329640

Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)

Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.

Conditions

• Locally Advanced HER2-positive Breast Cancer

Interventions

Type	Name	Description
DEVICE	Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide	1. Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by; 2. Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-09-01
• Completion: 2012-09-01
• First posted: 2011-04-06
• Last updated: 2014-05-21

Locations

1 site across 1 country: Brazil