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)

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.

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

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.

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• Roche Pharma AG

  collaborator INDUSTRY

• Teva Pharmaceuticals USA

  collaborator INDUSTRY

• Vifor Pharma

  collaborator INDUSTRY

• GBG Forschungs GmbH

  lead OTHER

Principal Investigators

• Andreas Schneeweiss, MD, Prof. · NTC Heidelberg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2016-11-30

Completion

2017-01-30

Countries

• Germany

Study Locations