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A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer

NCT00637481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-12-29

No results posted yet for this study

Summary

Chemoprevention is the use of certain drugs to keep cancer from forming. The use of atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying the best dose of atorvastatin in preventing breast cancer in women at increased risk for breast cancer.

Conditions

  • Atypical Ductal Breast Hyperplasia
  • Breast Cancer
  • Ductal Breast Carcinoma in Situ
  • Lobular Breast Carcinoma in Situ

Interventions

DRUG

atorvastatin calcium

Given orally

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Banu Arun · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

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 NCT00637481 on ClinicalTrials.gov