RecruitingPhase 4NCT05183828

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

Association of HSD3B1 Genotype With Response to Preoperative Letrozole Therapy Among Postmenopausal Women With Estrogen-Receptor Positive (ER+) HER2/Neu-Negative (HER2-) Invasive Carcinomas of the Breast


Sponsor

University of Washington

Enrollment

68 participants

Start Date

Jan 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This stage IV trial examines how a mutation in HSD3B1 (1245C) gene affects treatment of stage I-III breast cancer. This trial may help researchers determine if mutations in HSD3B1 decreases the efficacy of aromatase inhibitor therapy such as letrozole. Letrozole may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a genetic variation in the HSD3B1 gene affects how well hormone-blocking therapy works in postmenopausal women with early-stage, hormone-sensitive breast cancer before surgery. **You may be eligible if:** - You are a postmenopausal woman 18 years or older - You have been diagnosed with stage I–III breast cancer that is estrogen receptor-positive (ER+) and HER2-negative, confirmed by biopsy - Your tumor is at least 1 cm in size - Your tumor has a Ki67 level of at least 10% (indicating moderate to high tumor activity) - You are a candidate for surgery **You may NOT be eligible if:** - You are premenopausal (unless on ovarian suppression therapy) - Your cancer is HER2-positive - Your cancer is ER-negative - You are pregnant or planning to become pregnant - Your tumor is too small to provide sufficient tissue after the diagnostic biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of saliva samples

DRUGLetrozole

Given PO

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT05183828


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