Inflammatory Breast Cancer Clinical Trial
Official title:
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)
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.
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.
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