Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2 — TRAIN-2  

Breast Cancer Clinical Trial

Official title: Optimizing Neoadjuvant Systemic Treatment for HER2 Positive Breast Cancer - the TRAIN-2 Study

Status Active, not recruiting

Clinical Trial Summary

This study compares two schedules of upfront chemotherapy in HER positive breast cancer.

Clinical Trial Description

Upfront trastuzumab treatment is beneficial to patients with HER2 positive breast cancer. The potential synergistic cardiotoxicity of trastuzumab and anthracyclines has led to the development of non-anthracycline containing regimens, which have shown high pathologic complete response rates. Anthracyclines remain very active in HER2 positive breast cancer, however, and increasing evidence now supports safe combination of trastuzumab and epirubicin. Therefore, the addition of epirubicin to a non-anthracycline containing regimen may further improve outcome for patients with HER2 positive breast cancer.

Several reports confirmed benefit of dual HER2 blockade by adding pertuzumab to a trastuzumab containing neoadjuvant regimen. The results of the combined treatment in the Neosphere study, however, are similar to what we found in a phase II trial using a weekly paclitaxel, trastuzumab, carboplatin combination with pCR rates of approximately 44%. Adding pertuzumab to this regimen is likely to also increase the high pCR rate and to add substantial benefit to patients. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2 Positive

• NCT number: NCT01996267
• Study type: Interventional
• Source: The Netherlands Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2013
• Completion date: December 2030