Actively Recruiting
Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
Led by University of Washington · Updated on 2026-01-26
68
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Postmenopausal status defined by age 60 or older, or cessation of regular menses for at least 12 months with no other cause, or bilateral oophorectomy
- Histologically confirmed stage I to III breast carcinoma
- Tumor size at least 1.0 cm with sufficient tissue remaining after biopsy
- Candidate for surgical tumor removal
- Estrogen receptor-positive breast cancer with more than 1% positive cells
- Ki67 tumor marker level at or above 10%
- HER2-negative breast cancer as defined by guidelines
- Willingness to comply with all study procedures and available for study duration
- Prior hormone contraceptives or replacement therapy allowed if stopped more than 6 months before diagnosis
- Ability to take oral medication and willingness to follow study intervention
You will not qualify if you...
- Tumor biopsy sample unlikely to provide adequate tissue for biomarker tests
- Inoperable or metastatic breast cancer
- Previous breast cancer treatments including surgery, radiation, chemotherapy, or endocrine therapy
- Hormonal therapy for breast cancer or prevention within 1 year prior to enrollment
- Planned neoadjuvant chemotherapy
- Use of hormonal contraceptives within 6 months before diagnosis
- Treatment with another investigational drug or intervention within 28 days before starting letrozole
- History of allergic reactions to letrozole or similar compounds
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Meghan R. Flanagan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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