LOCALLY ADVANCED BREAST CANCER MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: FEMARA*30CPR RIV 2,5MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Letrozole
Concentration unit: mg milligram(s)
Concentration number: 2.5-
Trade Name: DECAPEPTYL*1FL 3,75MG+2
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients with histologically proven, locally advanced, primary breast cancer (cT2-T4b, N0-2, M0) ? Endocrine responsive primary breast cancer (ER and PgR #8805; 50%) ? Absence of HER2/neu overexpression or amplification ? Absence of distant metastasis Are the trial subjects under 18? no Number of subjects for this age range: 0 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
Exclusion criteria: ? Presence of HER2/neu overexpression or amplification ? Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. ? Patients with distant metastatic disease ? Previous adjuvant and/or neoadjuvant treatment for breast cancer ? Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will investigate the antitumor efficacy of Letrozole in patients diagnosed with endocrine responsive (ER and PgR ≥ 10%) locally advanced breast tumors. The primary objective of the study is to estimate the effect of a prolonged preoperative treatment in terms of clinical response (complete and partial);Secondary Objective: The rate of pathological complete remission 2. The disease free survival (DFS) and overall survival (OS) 3. The extent of ovarian function suppression in premenopausal women upon letrozole by serial measurements of circulating gonadotropins, estradiol and estrone.;Primary end point(s): rate of objective response (CR and PR) after 6 and 9 months of letrozole. | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed