Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Breast Neoplasms Clinical Trial

Official title: Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab (TCH) In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration

Status Completed

Clinical Trial Summary

Primary objective:

• Compare disease-free survival in women with HER2-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

Secondary objective:

• Compare overall survival of patients treated with these regimens.

• Compare the toxic effects (including cardiac) of these regimens in these patients.

• Compare quality of life of patients treated with these regimens.

• Compare pathologic and molecular markers for predicting efficacy of these regimens in these patients.

• For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in patients treated with these regimens.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT00021255
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: April 2001
• Completion date: December 2014