Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Healthy, no Evidence of Disease and Lobular Breast Carcinoma in Situ, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Three one-sided two-sample t-tests will be conducted on the ratios of the mean percentage of suppression simultaneously to test for non-inferiority. A multivariate t-distribution is used to derive the critical value and the power.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2010-03 |
| Phase | Phase 1 |
What the finished NCT01077453 record still lists
NCT01077453 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 167-participant average among 11 other Healthy, no Evidence of Disease trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy, no Evidence of Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01077453's enrollment target sits among peer trials
112 4th of 11 higher than 8 of 11 other Healthy, no Evidence of Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy, no Evidence of Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Studying Different Formulations of SR13668 in Healthy Volunteers
COMPLETED · Phase 1
-
Diindolylmethane in Healthy Volunteers
COMPLETED · Phase 1
-
Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers
COMPLETED · Phase 1
-
Se-Methyl-Seleno-L- Cysteine (MSC) in Treating Healthy Patients
COMPLETED · Phase 1
-
Lycopene in Healthy Male Participants
COMPLETED · Phase 1
-
A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04511013 · 112 participants · Phase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
- NCT04551560 · 112 participants · NA
Stress and Congestive Heart Failure
- NCT04872166 · 112 participants · Phase 1
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
- NCT05024773 · 112 participants · Phase 3
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia