NCT05183828 Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
| NCT ID | NCT05183828 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Washington |
| Condition | Anatomic Stage I Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2022-01-23 |
| Primary Completion | 2026-06-30 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * Subject must be female age \>= 18 years. * Postmenopausal as defined by at least one of the following: * Age \>= 60 years; * Age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; or serum estradiol and follicle stimulating hormone levels within the local laboratory's normal reference range for postmenopausal females; * Documented bilateral oophorectomy. * Histologically confirmed diagnosis of carcinoma of the breast, clinical stage I-III. * Minimum tumor diameter of 1.0 cm as assessed by palpation or imaging (e.g., ultrasound) and with enough tumor left after the initial diagnostic biopsy to provide tumor tissue during the planned tumor resection. * Candidate for surgical resection. * ER+ breast cancer (\> 1% positive stained cells) based on the most recent tumor biopsy documented by a local laboratory or medical record. * Ki67 \>= 10%. * HER2-negative breast cancer based on the
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