The HOT Study: Hormone Replacement Therapy Opposed by Low Dose Tamoxifen. A Phase III Trial of Breast Cancer Prevention With Low Dose Tamoxifen in HRT Users.

IEO S51/200

The propose of this trial is to assess the effect of low dose tamoxifen for breast cancer prevention in HRT (Hormone Replacement Therapy)users.

2002-03-01

2018-12-01

2023-12-01

Active (not recruiting)

Early phase I

1884

Inclusion Criteria: * Postmenopausal women candidates to HRT for control of menopausal symptoms or prevention of postmenopausal disorders. women currently undergoing HRT for any duration; (women off HRT for 1 year or longer are considered de novo users); * negative bilateral mammography (within the last 6 months); * written informed consent. 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, symptomatic myomata; * alterations of metabolic, liver, renal and cardiac grade 2 function (NCI criteria grade 2 or higher); * any type of retinal disorders, severe cataract and glaucoma; * presence of significant risk factors for venous events, including immobilization within the last 3 months for longer than 2 weeks following surgery or trauma, history of estrogen-associated and "sine causa" superficial phlebitis, 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; any other factor that at the investigator's discretion contraindicates the use of either tamoxifen or HRT.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1884, 'type': 'ACTUAL'}}

2023-06-28