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NCT01077453 · ClinicalTrials.gov registry record · Phase 1

Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer

A Phase 1 study of Healthy, no Evidence of Disease and Lobular Breast Carcinoma in Situ, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
112
Enrollment target
3
Study locations

NCT01077453 is a Phase 1 study of Healthy, no Evidence of Disease and Lobular Breast Carcinoma in Situ that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 112 participants, below the 167-participant average among 11 other Healthy, no Evidence of Disease trials with a reported enrollment target (33% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT01077453, a Phase 1 study of Healthy, no Evidence of Disease and Lobular Breast Carcinoma in Situ, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
112 participants
Enrollment target
3
Study locations

Study Summary

This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk for breast cancer.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG letrozole
  • OTHER quality-of-life assessment

Study Locations (3)

Arizona

  • Arizona Cancer Center - Tucson - Tucson
  • University of Arizona Health Sciences Center - Tucson

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2010-03
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01077453

The ClinicalTrials.gov registry entry for NCT01077453 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 167-participant average among 11 other Healthy, no Evidence of Disease trials with a reported enrollment target (33% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy, no Evidence of Disease appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT01077453 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Minnesota.

Frequently Asked Questions

What is clinical trial NCT01077453 about?

NCT01077453 is a clinical study titled "Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer". This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cance...

What is the current status of trial NCT01077453?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2010-03.

What conditions does trial NCT01077453 study?

This clinical trial studies the following conditions: Healthy, no Evidence of Disease, Lobular Breast Carcinoma in Situ.

What interventions are being tested in trial NCT01077453?

The interventions under investigation include: laboratory biomarker analysis (OTHER), letrozole (DRUG), quality-of-life assessment (OTHER).

Who is sponsoring clinical trial NCT01077453?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01077453 being conducted?

This trial has 3 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.