Overview

Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) Users

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
Female
Summary
The propose of this trial is to assess the effect of low dose tamoxifen for breast cancer prevention in HRT (Hormone Replacement Therapy)users.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Institute of Oncology
Treatments:
Hormones
Tamoxifen
Criteria
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.