The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of G-CSF. To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due to toxicity of the regimen.
Estrogen receptor negative breast cancer may be defined as distinct biologic subtype disease, more aggressive with a typical molecular portrait. \[30\] This subtype seems to have a poor prognosis and poor treatment options because these patients are not candidate to hormonal therapy. Novel treatment strategies focusing upon this subtype are necessary in the future. \[31\] There are reports of clinical benefit in estrogen receptor negative patients treated with dose-dense chemotherapy (see background CALGB 9741 and MIG-1 study). In the CALGB 9741 study, patients randomized to receive dose-dense regimens experienced severe toxicities during paclitaxel treatment leading to dose reduction in 7% and 5%respectively. Ixabepilone has shown consistent activity and an acceptable safety profile in patients with all stages breast cancer. This phase II study evaluate the feasibility of dose-dense Ixabepilone (4 cycles) given sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) all given every 14 days with the support of Filgrastim as neo-adjuvant treatment for ER-negative breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Ixabepilone is administered as 3-hour intravenous infusion (iv) at the dose of 40 mg/mq, every 14 days for 4 cycles (with G-CSF support), sequentially to Fluorouracil 600 mg/mq as intravenous (iv) infusion, Epirubicin 90 mg/mq as intravenous (iv) bolus and Cyclophosphamide 600 mg/mq as intravenous (iv) infusion every 14 days for 4 cycles (with G-CSF support)
Azienza Osped.Treviglio - Caravaggio
Treviglio, BG, Italy
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Ospedale Civile di Campobasso - A. Cardarelli
Pathologic Complete Response (pCR)
Time frame: one year
Feasibility/Tolerability for an individual patient is defined as the absence of hematologic toxicities requiring dose reduction as per protocol
Time frame: one year
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Campabasso, CB, Italy
Ospedale civile Renzetti di Lanciano
Lanciano, CH, Italy
Azienda Ospedaliera S. Anna
Como, CO, Italy
Azienda Ospedaliera Nesina Garibaldi
Catania, CT, Italy
I.S.T. - Istituto Nazionale per la Ricerca sul Cancro
Genova, GE, Italy
Presidio Ospedaliero di Macerata
Mecerata, MC, Italy
I.R.C.C.S. Multimedica - Casa di Cura Accreditata
Sesto San Giovanni, Milano, Italy
Azienda Ospedaliera R. Silvestrini
Perugia, PG, Italy
...and 5 more locations