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

Who is this study for? Postmenopausal women with estrogen-receptor positive HER2/Neu-negative invasive carcinomas of the breast
What treatments are being studied? Letrozole
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 most recent tumor biopsy and documented by a local laboratory or medical record. HER2-negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Prior use of hormone contraceptives and replacement therapy is allowed (e.g., estrogen and/or progestin) if discontinued \> 6 months prior to diagnosis. Vaginal preparations are allowed.

• Ability to take oral medication and be willing to adhere to the study intervention.

Locations
United States
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
Meghan R. Flanagan
mrf22@uw.edu
206-667-6736
Time Frame
Start Date: 2022-01-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 68
Treatments
Experimental: Treatment (letrozole)
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.
Related Therapeutic Areas
Sponsors
Leads: University of Washington
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov