locally advanced breast cancer MedDRA version: 6.1 Level: PT Classification code 10057654
Conditions
Interventions
Trade Name: DECAPEPTYL*1FL 3,75MG+2ML+1SIR
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Triptorelin
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 ad, N0-3c, M0) or Patients with histologically proven local recurrence after breast conserving surgery (rT1- T4, N0-3c, M0) or Patients with histologically proven local recurrence after mastectomy (M1 on the chest wall) or Patients with histological proven regional recurrence (axillary, suvraclavicular and internal mammary chain lymph nodes) ? Patients with HER2 overexpression (+++)or with Her2/neu gene amplification ? Patients must be suitable for local treatment (radiotherapy and/or surgery) in a multidisciplinary program ? Bilateral breast cancers are eligible ? Women aged 18?75 years ? ER PgR and c-erbB-2 expression defined according to EIO guidelines ? Performance status 0-2 (ECOG scale) ? Measurable and/or evaluable lesions ? No evidence of distant metastatic disease ? No clinically significant concomitant illness such as diabetes, cardiovascular, renal, or neurological impairments ? LVEF >= 55% at basal echocardiography ? Absence of psychiatric illness undermining a correct understanding of the treatment program ? WBC > 3,000/mm3; PLTS > 100,000/mm3 ? AST, ALT, gamma-GT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Absence of HER2/neu overexpression or amplification with FISH-test ? Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV ? Patients with distant metastatic disease ? Clinical grade greater than or equal to 2 peripheral neuropathy. ? Previous adjuvant and/or neoadjuvant treatment with anthracyclines, cisplatin and/or 5-FU ended less than 12 months before study entry ? Previous adjuvant and/or neoadjuvant treatment with trastuzumab ended less than 6 months before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to estimate the antitumor activity of chemotherapy (CCF) plus trastuzumab in terms of objective response in locally advanced breast cancer;Secondary Objective: 1. The rate of pathological complete remission 2. The disease free survival (DFS) and overall survival (OS) 3. The collection and storage of tumor tissue, plasma samples for future analysis of molecular pathways and gene candidates.;Primary end point(s): rate of clinical response (partial and complete remission) | — |
Countries
Italy
Outcome results
None listed