Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
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ClinicalTrials.gov Identifier: NCT05183828 |
Recruitment Status :
Recruiting
First Posted : January 11, 2022
Last Update Posted : May 7, 2024
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Condition or disease | Intervention/treatment | Phase |
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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 | Procedure: Biospecimen Collection Drug: Letrozole Other: Questionnaire Administration | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 23, 2022 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Arm | Intervention/treatment |
---|---|
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.
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Procedure: Biospecimen Collection
Undergo collection of saliva samples
Other Names:
Drug: Letrozole Given PO
Other Names:
Other: Questionnaire Administration Ancillary studies |
- Changes in Ki67 [ Time Frame: Before (baseline) and up to 9 months after surgery ]Will be assessed according to germline status.
- Changes in Ki67 [ Time Frame: Before (baseline) and up to 9 months after surgery ]Will be assessed according to somatic HSD3B1 (1245C) variant status.
- Changes in estrogen receptor (ER)alpha [ Time Frame: Before (baseline) and up to 9 months after surgery ]Will be assessed according to germline status.
- Changes in estrogen receptor (ER)alpha [ Time Frame: Before (baseline) and up to 9 months after surgery ]Will be assessed according to somatic HSD3B1 (1245C) variant status.
- Changes in ER beta [ Time Frame: Before (baseline) and up to 9 months after surgery ]Will be assessed according to germline status.
- Changes in ER beta [ Time Frame: Before (baseline) and up to 9 months after surgery ]Will be assessed according to somatic HSD3B1 (1245C) variant status.
- Effect of HSD3B1 (1245C) variant on changes in Ki67 [ Time Frame: Before (baseline) and up to 9 months after surgery ]Will evaluate whether androgen receptor (AR)+ modifies the effect of HSD3B1 (1245C) variant on changes in Ki67 before and after preoperative letrozole treatment, and whether this effects ER- and AR- gene expression signatures.
- Expression of 3betaHSD1 [ Time Frame: Up to 9 months after surgery ]Will compare expression of 3betaHSD1 according to HSD3B1 allele status.
- Expression of intracellular androgen [ Time Frame: Up to 9 months after surgery ]Will compare expression of intracellular androgen according to HSD3B1 allele status.
- Expression of estrogen levels [ Time Frame: Up to 9 months after surgery ]Will compare expression of estrogen levels according to HSD3B1 allele status.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject must be female age >= 18 years.
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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.
- 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). Vaginal preparations are allowed.
- Ability to take oral medication and be willing to adhere to the study intervention.
Exclusion Criteria:
- 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 for the current breast cancer, or received any therapy within the last 1 year for a prior primary breast cancer.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05183828
Contact: Meghan R. Flanagan | 206-667-6736 | mrf22@uw.edu |
United States, Washington | |
Fred Hutch/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Meghan R. Flanagan 206-667-6736 mrf22@uw.edu | |
Principal Investigator: Meghan R. Flanagan |
Principal Investigator: | Meghan R. Flanagan | Fred Hutch/University of Washington Cancer Consortium |
Responsible Party: | University of Washington |
ClinicalTrials.gov Identifier: | NCT05183828 |
Other Study ID Numbers: |
RG1121659 NCI-2021-12428 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) STUDY00013424 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P30CA015704 ( U.S. NIH Grant/Contract ) |
First Posted: | January 11, 2022 Key Record Dates |
Last Update Posted: | May 7, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Breast Neoplasms Carcinoma, Ductal, Breast Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma Carcinoma, Ductal |
Neoplasms, Ductal, Lobular, and Medullary Letrozole Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |