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

NCT01579734 | Unknown Phase 3 DMC

• 1 other identifier: IEO S51/200
• Study Type: interventional
• Target: 1,884
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer chemoprevention postmenopause

Outcome Measures

Primary Outcomes (1)

• breast cancer incidence

  The primary objective is to assess if tamoxifen at a low dose reduces the incidence of breast cancer in healthy postmenopausal women undergoing or willing to initiate hormone replacement therapy (HRT), including the women who will eventually withdraw HRT during the 5 year intervention period and additional 5 years of follow up.

  10 years

Secondary Outcomes (1)

• Incidence of adverse events

  10 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 tablet day for 5 years

Drug: Placebo

Tamoxifen

ACTIVE COMPARATOR

Tamoxifen 5 mg, (1 tablet) day for 5 years

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

1 tablet, 5 mg / day for 5 years

Also known as: Nolvadex, Istubal, Valodex

Tamoxifen

Placebo DRUG

1 tablet day for 5 years

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Umberto Veronesi, MD

  European Institute of Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: April 18, 2012
• Study Start: March 1, 2002
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

IT (1)