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

NCT01579734 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1884

Last updated 2023-06-28

No results posted yet for this study

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

Interventions

DRUG

Tamoxifen

1 tablet, 5 mg / day for 5 years

DRUG

Placebo

1 tablet day for 5 years

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Umberto Veronesi, MD · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2018-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01579734 on ClinicalTrials.gov