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
University of Washington
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.
Description
OUTLINE: Patients receive letrozole orally (PO) once daily (QD) for 21 days in the absence of disease progression or unacceptable toxicity. 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. Patients also undergo collection of saliva samples.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 ass…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of saliva samples
- DrugLetrozole
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington