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Aromatase Inhibitor

Letrozole for Breast Cancer

Phase 4

Recruiting

Led By Meghan R. Flanagan

Research Sponsored by University of Washington

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 up to 9 months after surgery

Awards & highlights

Study Summary

This trial examines if a mutation in the HSD3B1 gene affects the efficacy of letrozole in treating stage I-III breast cancer.

Who is the study for?

This trial is for postmenopausal women aged 18 or older with stage I-III breast cancer that hasn't been treated yet. Participants must be able to take oral medication, have a tumor at least 1cm in size, ER+ and HER2-negative breast cancer. They should not have had hormonal therapy for breast cancer within the last year and must be candidates for surgical resection.Check my eligibility

What is being tested?

The study is examining how a gene mutation (HSD3B1) affects the effectiveness of letrozole, an aromatase inhibitor used in treating hormone-sensitive breast cancer. It involves collecting biospecimens and administering questionnaires to understand treatment outcomes.See study design

What are the potential side effects?

While specific side effects are not listed here, letrozole can commonly cause joint pain, hot flashes, weakness, fatigue, increased sweating and may lead to bone thinning over long-term use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before (baseline) and up to 9 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before (baseline) and up to 9 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and before (baseline) and up to 9 months after surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Changes in ER beta

Changes in Ki67

Changes in estrogen receptor (ER)alpha

+4 more

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 Treatment3 Interventions

Patients receive letrozole PO QD for 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of saliva samples. If tumor resection occurs before or after day 22, letrozole administration must occur for a minimum of 14 days and a maximum of 70 days of total treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1720

Letrozole

2002

Completed Phase 4

~2770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,749 Previous Clinical Trials

1,847,980 Total Patients Enrolled

20 Trials studying Breast Cancer

3,253 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,708 Previous Clinical Trials

40,932,638 Total Patients Enrolled

942 Trials studying Breast Cancer

1,543,966 Patients Enrolled for Breast Cancer

Meghan R. FlanaganPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Frequently Asked Questions

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

What is the total sample size for this clinical research?

"Affirmative. According to information posted on clinicaltrials.gov, this medical research is actively enrolling patients as of October 19th 2022. The study was initially announced on January 23rd and requires 60 participants from one location."

Answered by AI

What potential adverse reactions have been associated with Letrozole?

"As this treatment is approved, the safety of Letrozole was assessed as a 3 on our 1 to 3 scale."

Answered by AI

Are there any opportunities remaining to partake in this experiment?

"Clinicaltrials.gov attests that this medical experiment is presently seeking participants, having been posted on January 23rd 2022 and last updated on October 19th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer

2022. "Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05183828.

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