A feasibility study of dose-dense FEC wiith G-CSF support followed by dose-dense Ixabepilone wiith G-CSF support as neoadjuvant chemotherapy in ER- negative breast cancer - GIM9 (NEO-ADIXERN)

Conditions: In ER-negative breast cancer
MedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female

Registration Number: EUCTR2008-000486-29-IT

Lead Sponsor: CONSORZIO ONCOTECH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1.Histological documented diagnosis of breast cancer by incisional biopsy 2.Clinical T.2 (T > 2cm) 3.ER negative breast cancer, independently from PgR and HER2 status 4.Females age .18 and .70 years 5.ECOG performance status 0-1 6.No prior treatment for breast cancer excluding therapy for DCIS 7.Subjects with hormone replacement therapy are eligible if this therapy is discontinued at least 2 weeks before starting therapy 8.Neutrophils > 2x109/L, Hgb > 9 g/dL, platelets > 100x109/L 9.Total bilirubin < 1.5 time the upper limit of normal (ULN) of the Institutional normal values and AST and/or ALT < 2.5 ULN, alkaline phosphatase < 2.5 ULN 10.Serum creatinine < 1.5 times the upper limit of normal 11.Normal cardiac function (normal ECG required in all patients, normal ECG and MUGA or Echocardiography with EF only in HER-2 positive patients) 12.Negative pregnancy test prior to inclusion in the study (if potentially childbearing) 13.Signed Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Prior or current history of ipsilateral or controlateral breast invasive cancer. A past or current history of ipsilateral ductal carcinoma in situ or ipsilateral/controlateral lobular neoplasia in situ are not an exclusion criteria as well as a controlateral ductal carcinoma in situ removed by mastectomy 2.Metastatic breast cancer (M1) 3.Histology other than adenocarcinoma of the breast 4.Male patients 5.Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception) 6.Patients unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational drug 7.History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ 8.Symptomatic peripheral neuropathy grade 2 according to the NCI CTC

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To evaluate the efficacy of this regimen in terms of pCR (pathologic Complete Responses) in the breast and in the axilla;Primary end point(s): Assess treatment tolerability defined as the absence of any grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomit and bone pain

Secondary Outcome Measures