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Aromatase Inhibitor

Letrozole for Hormone Receptor-Positive Breast Cancer

Phase 3
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
within 1 year if the patient has a history of hypercholesterolemia controlled with cholesterol-lowering therapy and/or therapeutic lifestyle changes or if the patient has a history of one or more of the following risk factors for future cardiovascular events: diabetes, hypertension, obesity, tobacco use, hypertriglyceridemia, documented coronary artery disease, or family history of premature coronary heart disease.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights

Study Summary

This trial is studying letrozole to see if it is more effective than a placebo in treating postmenopausal women with hormone receptor-positive breast cancer.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you have high cholesterol, you must have it under control with medication or lifestyle changes for at least one year. If you have a history of diabetes, high blood pressure, obesity, smoking, high triglycerides, heart disease, or a family history of early-onset heart disease, you may not be eligible to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free Survival
Secondary outcome measures
Arterial Thrombotic Events
Breast Cancer-free Interval
Distant Recurrence
+2 more

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538
10%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2 LetrozoleExperimental Treatment1 Intervention
Patients receive oral letrozole once daily for up to 5 years.
Group II: Group 1 PlaceboPlacebo Group1 Intervention
Patients receive oral placebo once daily for up to 5 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved

Find a Location

Who is running the clinical trial?

NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
133,022 Total Patients Enrolled
44 Trials studying Breast Cancer
96,564 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,909,309 Total Patients Enrolled
938 Trials studying Breast Cancer
1,539,367 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,705,825 Total Patients Enrolled
56 Trials studying Breast Cancer
17,222 Patients Enrolled for Breast Cancer

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00382070 — Phase 3
Breast Cancer Research Study Groups: Group 2 Letrozole, Group 1 Placebo
Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT00382070 — Phase 3
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00382070 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient is 55 or younger, can they join this research project?

"The age range for patients that are eligible for this study are between 18 to 120 years old."

Answered by AI

What is the Letrozole FDA approval status?

"Letrozole has received a Phase 3 safety ranking from our team at Power. This means that, while there is some efficacy data available, there are multiple rounds of supportive safety data."

Answered by AI

Can people with the specified medical condition still enroll in this research project?

"Unfortunately, this study is no longer enrolling patients. The clinical trial was originally posted on 8/1/2006 with the latest update being on 10/4/2021. However, if you are still interested in participating in a clinical trial, there are 2695 trials for breast cancer and 164 for Letrozole that are currently looking for participants."

Answered by AI

What is the efficacy of Letrozole in other medical trials?

"Letrozole was first studied in 1995 at the NIH Clinical Center. So far, there have been 18,466 completed studies on this medication. Additionally, there are 164 active clinical trials involving letrozole; many of these are based out of Manitowoc, Wisconsin."

Answered by AI

What is the Letrozole medication approved to help with?

"While letrozole is most often prescribed as a treatment for breast cancer, it can also help patients who are experiencing anovulatory cycles, tamoxifen side effects, and postmenopausal symptoms."

Answered by AI

Is this trial widely available in city?

"Currently, this clinical trial is running at 100 sites. With locations in Manitowoc, Reading and Montreal (amongst others), it is important that you pick a location nearest to you - this will cut down on travel requirements if you choose to participate."

Answered by AI

How many research participants are being enrolled in this trial?

"Right now, this study is not enrolling patients. It was first posted on 8/1/2006 and the most recent update was 10/4/2021. There are currently 2695 breast cancer trials and 164 Letrozole trials that are looking for participants."

Answered by AI

Which patients fit the screening criteria for this research project?

"This clinical trial is recruiting breast cancer patients that are between 18 and 120 years old. They aim to enroll around 3966 individuals in total."

Answered by AI
Recent research and studies
~213 spots leftby Mar 2025