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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial
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.
Who is the study for?
This trial is for postmenopausal women who have been disease-free since their initial breast cancer diagnosis and completed 57-63 months of hormone therapy. They must have had estrogen or progesterone receptor-positive tumors, undergone specific surgeries with axillary nodal staging, and be in good physical condition (ECOG status 0 or 1). Women on sex hormonal therapies or with certain health conditions are excluded.
What is being tested?
The study is testing the effectiveness of Letrozole, a drug that lowers estrogen levels to treat hormone receptor-positive breast cancer, against a placebo. It's designed to see if continuing treatment with Letrozole after standard hormone therapy provides additional benefits.
What are the potential side effects?
Letrozole may cause hot flashes, joint pain, fatigue, increased sweating, nausea and osteoporosis-related issues due to its effect on reducing estrogen levels in the body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease-free Survival
Secondary study objectives
Arterial Thrombotic Events
Breast Cancer-free Interval
Distant Recurrence
+2 moreSide effects data
From 2018 Phase 4 trial • 79 Patients • NCT0213753810%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
88 Previous Clinical Trials
136,336 Total Patients Enrolled
45 Trials studying Breast Cancer
98,364 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,019,222 Total Patients Enrolled
942 Trials studying Breast Cancer
1,439,292 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,638 Previous Clinical Trials
2,770,237 Total Patients Enrolled
57 Trials studying Breast Cancer
17,297 Patients Enrolled for Breast Cancer
Norman Wolmark, MDPrincipal InvestigatorNSABP Foundation Inc
59 Previous Clinical Trials
79,751 Total Patients Enrolled
29 Trials studying Breast Cancer
64,899 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate in this study if you have any of the following conditions:You have had a bone fracture in your wrist, hip, or spine that was not caused by an injury.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.You have had another type of cancer in the past, but you are considered to be cured for at least 5 years, and your doctor believes the cancer is unlikely to come back. However, if you had certain types of non-invasive cancers in the past 5 years, you may still be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 Letrozole
- Group 2: Group 1 Placebo
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.