A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto)

• Status: Completed
• Trial end date: 2017-01-30

Summary

Two regimen are currently considered to have highest efficacy for patients with high-risk early stage breast cancer: sequential treatment of high dose epirubicin, taxane, and cyclophosphamide concomitantly with a dual HER2-blockade, and weekly treatment with paclitaxel/non-pegylated liposomal doxorubicin with dual HER2-blockade or carboplatin. The aim of the GeparOcto study is to compare those two regimen/strategies.

Both regimens are myelosuppressive with a significant incidence of chemotherapy induced anaemia.

The second aim of the GeparOcto study is therefore to compare the use of parental ferric carboxymaltose versus physician's choice for the treatment of chemotherapy-induced anemia in patients with iron deficiency.

• Phase: Phase 3

Details

• Lead Sponsor: German Breast Group
• Collaborators: Amgen; Roche Pharma AG; TEVA; Teva Pharmaceuticals USA; Vifor Pharma
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Doxorubicin; Epirubicin; Ferric Compounds; Liposomal doxorubicin; Paclitaxel; Pertuzumab; Trastuzumab