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A Prevention Trial in Subjects at High Risk for Breast Cancer

NCT01500577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-06-18

No results posted yet for this study

Summary

The primary objective of the proposed trial is to assess. The efficacy and the safety of a daily administration of nimesulide or simvastatin to change the expression of a large set of tissue and circulating surrogate endpoint biomarkers (SEBs) of breast carcinogenesis in women at higher risk of developing a hormone non-responsive (ER neg) breast cancer. The primary endpoint is the change in prevalence of atypical cells and cellular proliferation (Ki-67), after 12 months of treatment.

Conditions

Interventions

DRUG

nimesulide

Nimesulide 100 mg (capsules). 100mg/die every day for 1 year. Oral administration

DRUG

Simvastatin

Simvastatin 20 mg (capsules). 20mg/die every day for 1 year. Oral administration

OTHER

Placebo

Placebo (capsules). 1 cps/die every day for 1 year. Oral administration

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2012-11-30
Completion
2013-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT01500577 on ClinicalTrials.gov