- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05183828
Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Meghan R. Flanagan
- Phone Number: 206-667-6736
- Email: mrf22@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Ancillary studies
Given PO
Other Names:
Undergo collection of saliva samples
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Ki67
Time Frame: Before (baseline) and up to 9 months after surgery
|
Will be assessed according to germline status.
|
Before (baseline) and up to 9 months after surgery
|
Changes in Ki67
Time Frame: Before (baseline) and up to 9 months after surgery
|
Will be assessed according to somatic HSD3B1 (1245C) variant status.
|
Before (baseline) and up to 9 months after surgery
|
Changes in estrogen receptor (ER)alpha
Time Frame: Before (baseline) and up to 9 months after surgery
|
Will be assessed according to germline status.
|
Before (baseline) and up to 9 months after surgery
|
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.
|
Before (baseline) and up to 9 months after surgery
|
Changes in ER beta
Time Frame: Before (baseline) and up to 9 months after surgery
|
Will be assessed according to germline status.
|
Before (baseline) and up to 9 months after surgery
|
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.
|
Before (baseline) and up to 9 months after surgery
|
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.
|
Before (baseline) and up to 9 months after surgery
|
Expression of 3betaHSD1
Time Frame: Up to 9 months after surgery
|
Will compare expression of 3betaHSD1 according to HSD3B1 allele status.
|
Up to 9 months after surgery
|
Expression of intracellular androgen
Time Frame: Up to 9 months after surgery
|
Will compare expression of intracellular androgen according to HSD3B1 allele status.
|
Up to 9 months after surgery
|
Expression of estrogen levels
Time Frame: Up to 9 months after surgery
|
Will compare expression of estrogen levels according to HSD3B1 allele status.
|
Up to 9 months after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Meghan R. Flanagan, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma, Ductal
- Breast Neoplasms
- Carcinoma
- Carcinoma, Ductal, Breast
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
Other Study ID Numbers
- RG1121659
- P30CA015704 (U.S. NIH Grant/Contract)
- NCI-2021-12428 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- STUDY00013424 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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