Breast Cancer
Conditions
Keywords
breast cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGIxabepilone
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)
Sponsors
Consorzio Oncotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological documented diagnosis of breast cancer by incisional biopsy * Clinical T\>=2 * Females age \>= 18 and \<= 70 years * ECOG performance status 0-1 * No prior treatment for breast cancer excluding therapy for DCIS * Subjects with hormone replacement therapy are eligible if this therapy is discontinued at least 2 weeks before starting therapy * Neutrophils \> 2x109/L, Hgb \> 9 g/dL, platelets \> 100x109/L * Total bilirubin \< 1 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 * Serum creatinine \< 1.5 times the upper limit of normal (ULN) * Normal cardiac function (normal ECG required in all patients, normal ECG and MUGA or Echocardiography with EF only in HER-2 positive patients) * Negative pregnancy test prior to inclusion in the study (if potentially childbearing) * Signed Informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response (pCR) | one year |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility/Tolerability for an individual patient is defined as the absence of hematologic toxicities requiring dose reduction as per protocol | one year |
Countries
Italy
Outcome results
None listed