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Aromatase Inhibitor

Letrozole for Breast Cancer

Phase 2

Recruiting

Led By Saranya Chumsri

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed un-resected operable invasive adenocarcinoma of the breast ≥ 0.5 cm with estrogen receptor (ER) and/or progesterone receptor (PR) positive ≥ 10%, and no human epidermal growth factor receptor 2 (HER2) amplification or overexpression

Willing and able to provide research tissue samples

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

Study Summary

This trial looks at letrozole as a treatment for operable hormone receptor positive, HER2 negative breast cancer. Letrozole is an aromatase inhibitor, which works by decreasing the amount of estrogen produced by the body.

Who is the study for?

This trial is for postmenopausal women over 18 with newly diagnosed, operable breast cancer that's hormone receptor-positive and HER2-negative. Participants must not have had prior treatments for their current breast cancer but may have taken preventive agents like tamoxifen.Check my eligibility

What is being tested?

The study tests Letrozole, a medication reducing estrogen to slow or stop the growth of certain breast cancers. It involves collecting biospecimens from patients who can undergo surgery to remove their cancer.See study design

What are the potential side effects?

Letrozole may cause joint pain, hot flashes, weakness, fatigue, increased sweating and cholesterol levels. Rarely it might lead to bone thinning (osteoporosis) or trigger heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER or PR positive, HER2 negative, and can be operated on.

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I am willing to give tissue samples for research.

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I am a woman aged 18 or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive version (vs.) AI-resistant hormone receptor (HR)+ breast cancer

Secondary outcome measures

Effects of estrogen deprivation on the immune microenvironment

Effects of estrogen deprivation on tumor immune microenvironment

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538

10%

Fracture

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (letrozole)Experimental Treatment2 Interventions

Patients receive letrozole PO QD for 2-8 weeks prior to surgery in the absence of disease progression or unacceptable toxicity. Patients then undergo collection of blood and tissue samples.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Letrozole

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,032 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,961 Total Patients Enrolled

83 Trials studying Breast Cancer

13,810 Patients Enrolled for Breast Cancer

Saranya ChumsriPrincipal InvestigatorMayo Clinic

8 Previous Clinical Trials

1,364 Total Patients Enrolled

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05447910 — Phase 2

Breast Cancer Research Study Groups: Treatment (letrozole)

Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT05447910 — Phase 2

Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05447910 — Phase 2

Frequently Asked Questions

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

How many individuals are being recruited for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial has resumed recruitment efforts since its initial posting on July 21st 2022 and most recent update on August 3rd 2022. The research is seeking 50 participants at a single site for enrollment."

Answered by AI

Is enrollment for this trial still available to those seeking treatment?

"Affirmative. Clinicaltrials.gov attests to this medical study's current recruitment status, which was initially made available on July 21st 2022 and was most recently revised on August 3rd of the same year. The trial is looking for 50 participants from 1 site."

Answered by AI

Has Letrozole been sanctioned by the Federal Drug Administration?

"As this is a Phase 2 study, there are limited data points available on the safety of Letrozole. Consequently, our team at Power has assessed it with an intermediate score of two."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer

2022. "Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05447910.