PREOPERATIVE ENDOCRINE TREATMENT WITH LETROZOLE ± TRIPTORELIN IN PATIENTS WITH ER AND PgR POSITIVE LOCALLY ADVANCED BREAST CANCER

Conditions: OCALLY ADVANCED BREAST CANCER
MedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2007-006026-10-IT

Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

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

? 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

?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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>2.The disease free survival (DFS) and overall survival (OS)<br><br>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.

Secondary Outcome Measures