NCT02125344

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)

A Randomized 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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 961 (actual)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Several recent strategies have improved efficacy of systemic treatment for patients with high-risk early stage breast cancer: the addition of a dual HER2-blockade for HER2-positive; the implementation of carboplatin for TNBC and the use of dose-dense or dose-dense, dose escalated chemotherapy in all high-risk subtypes of breast cancer. Two regimen are currently considered to have highest efficacy: sequential treatment of high dose epirubicin, taxane, and cyclophosphamide (ETC) concomitantly with a dual HER2-blockade mainly based on the AGO ETC adjuvant study, and weekly treatment with paclitaxel/non-pegylated liposomal doxorubicin with dual HER2-blockade or carboplatin (PM(Cb)) based on the GeparSixto study. 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. Anemia is often associated with impaired physical and cognitive function and consequently the patients suffer from a reduced quality of life. Surgical complications are higher in anemic patients. 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.

Conditions

• Tubular Breast Cancer Stage II
• Tubular Breast Cancer Stage III
• Mucinous Breast Cancer Stage II
• Breast Cancer Female NOS
• Invasive Ductal Breast Cancer
• HER2 Positive Breast Cancer
• Inflammatory Breast Cancer

Interventions

Type	Name	Description
DRUG	non-pegylated liposomal doxorubicin	20 mg/m2, i.V. 18 times weekly
DRUG	Carboplatin	Carboplatin AUC 1.5 18 times weekly (only in patients with triple-negative breast cancer).
DRUG	Paclitaxel	paclitaxel 80mg/m² 18 times weekly
DRUG	Epirubicin	150mg/m² every 2 weeks for 3 cycles.
DRUG	Cyclophosphamide	2000 mg/m² every 2 weeks for 3 cycles.
DRUG	Pertuzumab	420 (840) mg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm.
DRUG	Trastuzumab	Trastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm.
DRUG	Ferric carboxymaltose	after first anemia grade ≥2 and in case of randomisation: Ferric carboxymaltose i.V. 1000 mg followed 1 week later by an injection of ferric carboxymaltose i.V. 500 mg (if body weight is \<70 kg) or 1000 mg (if body weight is ≥70 kg). In case body weight is \<50 kg, both dosages will be reduced to 500 mg each.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-11-01
• Completion: 2017-01-30
• First posted: 2014-04-29
• Last updated: 2017-07-13

Locations

1 site across 1 country: Germany