In ER-negative breast cancer MedDRA version: 9.1 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: IXEMPRA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IXABEPILONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
CONSORZIO ONCOTECH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed