Randomized placebo-controlled phase III trial of low-dose tamoxifen women whit IntraEphitelial Neoplasia(IEN) - TAM-01

• Conditions: chemoprevention of breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2007-007740-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI GALLIERA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Women of age < 75 years - Women operated on for ER-positive lobular (LIN1, 2 and 3) or ductal (DIN 1-3, excluded DIN 1a) intraepithelial neoplasia. Both incident (diagnosis within 12 months) and prevalent cases (diagnosis between previous 12 and 60 months) will be included, upon stratification. - Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
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

- Any type of malignancy, with the exclusion of CIN and non-melanoma skin cancer; - Active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps; - Alterations of metabolic, liver, renal and cardiac grade 2 function (NCI criteria grade 2 or higher); - Any type of retinal disorders or severe cataract; - Presence of significant risk factors for venous events, including immobilization within the last 3 months for longer than 2 weeks following surgery or trauma, deep venous thrombophlebitis or other significant VTE (pulmonary embolism, stroke, etc.); - Use of tamoxifen, raloxifene or other SERMs within the last 4 weeks; - Anticoagulant therapy in progress (heparin or dicoumarol); - Active infections; - Severe psychiatric disorders or inability to comply to the protocol procedures;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified