NCT01996267

Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Breast Cancer
• HER2 Positive

Interventions

Type	Name	Description
DRUG	PTC+Pertuzumab	Cycle repeated every 21 days
DRUG	FEC-T+Pertuzumab	Cycle is repeated every 21 days

Timeline

• Start date: 2013-12-01
• Primary completion: 2018-12-01
• Completion: 2030-12-01
• First posted: 2013-11-27
• Last updated: 2024-03-29

Locations

33 sites across 1 country: Netherlands