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Aromatase Inhibitor

Intermittent letrozole therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Paul Goss, MD, PhD
Research Sponsored by Massachusetts General Hospital
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 3 years
Awards & highlights

Summary

The purpose of this research study is to study the effects of using aromatase inhibitor (AI) therapy intermittently on participants with breast cancer. AIs are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have become resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy, and that increasing estrogen levels even slightly by stopping AI therapy may inhibit the breast cancer cells.

Eligible Conditions
  • Breast Cancer

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With Decline in Serum CA 15-3 (Carcinoma Antigen 15-3)
Secondary study objectives
Median Time to Disease Progression With Intermittent Letrozole.
Serum HER-2/Neu Levels and Serum/Plasma Angiogenic Mediators

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

1Treatment groups
Experimental Treatment
Group I: Intermittent letrozole therapyExperimental Treatment1 Intervention
Letrozole 2.5 mg administered by mouth daily during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle based on CA 15-3 or CA 27.29 levels. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment.
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?

Massachusetts General HospitalLead Sponsor
3,000 Previous Clinical Trials
13,309,496 Total Patients Enrolled
80 Trials studying Breast Cancer
132,888 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteOTHER
1,103 Previous Clinical Trials
359,429 Total Patients Enrolled
144 Trials studying Breast Cancer
21,816 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,629 Previous Clinical Trials
2,725,293 Total Patients Enrolled
57 Trials studying Breast Cancer
21,297 Patients Enrolled for Breast Cancer
~0 spots leftby Oct 2025