chemoprevention of breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Product Name: Tamoxifen
Pharmaceutical Form: Tablet
INN or Proposed INN: Tamoxifen
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of
Sponsors
AZIENDA OSPEDALIERA OSPEDALI GALLIERA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women of age =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Incidence of invasive breast cancer;Main Objective: The primary endpoint of the proposed trial is to assess if tamoxifen at a low dose, 5mg/day, reduces the incidence of invasive breast cancer and ductal carcinoma in situ (DIN 1c, 2, 3) of the breast, in women operated on for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN1b, DIN 2, DIN3, 1a excluded) of the breast.;Secondary Objective: - To evaluate the incidence of other non-invasive breast disorders (i.e., LIN, ductal atypical hyperplasia), endometrial cancer, clinical bone fractures, cardiovascular events, venous thromboembolic events, clinically manifest cataract and overall mortality. - To assess intermediate biomarkers of efficacy and safety yearly: mammographic percent density, circulating IGF-I levels, endometrial thickness and genetic polimorphisms related to breast cancer risk such as COMT genes (estrogens inactivation process), MTHFR (folate metabolism), GH, IGFBP-3 and Androgen Receptor (related to breast cancer risk through activity and circulating levels of hormones); - In order to assess whether the blood concentrations of drug and metabolites could explain the biomarker level changes and to verify treatment adherence, the blood concentrations of tamoxifen and its main metabolites will be measured in a study subgroup. | — |
Countries
Italy
Outcome results
None listed