RECRUITING

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

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Breast Adenocarcinoma Invasive Breast Carcinoma of No Special Type

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-23

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05183828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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.	* Pre-treatment tumor biopsy sample not likely to provide adequate tissue sections for biomarker assays. * Inoperable or metastatic disease. * Subjects who have received any prior therapy for breast cancer, including radiotherapy, surgery, and cytotoxic and endocrine treatments. * The subject must not have had hormonal therapy for breast cancer treatment or for breast cancer prevention within 1 year prior to study enrollment. (Note: Synchronous breast, cancer (including bilateral breast cancer) at separate sites is permissible, provided the patient does not receive medical treatments for breast cancer or radiation therapy to the ipsilateral breast during the study intervention period. * Subjects with plans to undergo neoadjuvant chemotherapy. * Use of hormonal contraceptives within 6 months of diagnosis. * Treatment with another investigational drug or other intervention within 28 days before the first administration of letrozole. * History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to letrozole or any ingredients. * Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Inclusion Criteria

Exclusion 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 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.

* Pre-treatment tumor biopsy sample not likely to provide adequate tissue sections for biomarker assays.
* Inoperable or metastatic disease.
* Subjects who have received any prior therapy for breast cancer, including radiotherapy, surgery, and cytotoxic and endocrine treatments.
* The subject must not have had hormonal therapy for breast cancer treatment or for breast cancer prevention within 1 year prior to study enrollment. (Note: Synchronous breast, cancer (including bilateral breast cancer) at separate sites is permissible, provided the patient does not receive medical treatments for breast cancer or radiation therapy to the ipsilateral breast during the study intervention period.
* Subjects with plans to undergo neoadjuvant chemotherapy.
* Use of hormonal contraceptives within 6 months of diagnosis.
* Treatment with another investigational drug or other intervention within 28 days before the first administration of letrozole.
* History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to letrozole or any ingredients.
* Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Contacts and Locations

Study Contact

Meghan R. Flanagan

CONTACT

206-667-6736

mrf22@uw.edu

Principal Investigator

Meghan R. Flanagan

PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: University of Washington

Meghan R. Flanagan, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-23

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-01-23

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Adenocarcinoma
Invasive Breast Carcinoma of No Special Type