- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03719495
Evaluation of Endocrine Therapy Effects of Host Immunity in Early Stage Breast Cancer
Evaluation of the Effects of Endocrine Therapies on Immune Cell Repertoire and Function in Early Stage Estrogen Receptor Positive Breast Cancer Patients
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Felecia Henson
- Phone Number: 919-660-1278
- Email: breastcl@dm.duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Pre-menopausal and postmenopausal women with breast cancer who are initiating endocrine therapy or aromatase inhibitors.
Pre-menopausal and postmenopausal healthy women who are not on any hormonal birth control.
Description
Inclusion Criteria health cohorts:
- No known significant health problems.
- Available to participate for the planned duration of the investigational study (6 months).
- Able and willing to complete the informed consent process.
- Agree to have blood stored for future studies.
- Premenopausal women must have a history of regular menses defined as occuring monthly at regular intervals.
Postmenopausal women are defined as:
- prior bilateral oophorectomy
- 60 or older
age less than 60 years
- amenorrheic for 12 months or more in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression
- and follicle-stimulating hormone (FSH) and plasma estradiol in the postmenopausal range.
Inclusion Criteria (All endocrine therapy cohorts):
- Early stage breast cancer including T1-3, N0-3.
Histologically documented estrogen receptor positive adenocarcinoma of the breast that is (any progesterone status allowed):
- ER positive defined as ≥ 10% tumor cells positive for ER by immunohistochemistry (IHC), irrespective of staining intensity.
HER2 negative status is determined by:
- IHC 1+, as defined by incomplete membrane staining that is faint/barely perceptible and within >10% of invasive tumor cells, OR
- IHC 0, as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within ≤ 10% of the invasive tumor cells, OR
FISH negative based on:
- Single-probe average HEr2 copy number <4.0 signals/cell, OR
- Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number <4.0 signals/cell.
- Patients should have plans to initiate standard of care endocrine therapy in the adjuvant setting per primary provider.
- Patients can have had neoadjuvant or adjuvant chemotherapy with resolution of all hematologic toxicity to less than grade 1 by CTCAE v4.0 (e.g. Hg ≥10d/dL, Platelets 75,000mm3, Neutrophil >1500mm3).
- Patients should be willing to provide an archival tumor specimen from their definitive surgery.
- Able and willing to complete the informed consent process.
- Available to participate for the planned duration of the study (6 months).
- Agree to have bio-specimens stored for future research.
Exclusion Criteria (all cohorts):
- Relapsed or metastatic breast cancer.
- History of cancer or concurrent active malignancy (excluding basal cell skin cancer, resected squamous cell carcinoma of the skin).
- Receipt of neoadjuvant or previous endocrine therapy including ovarian function suppression in the neoadjuvant setting.
- Current use of hormonal birth control (copper IUD allowed) or estrogen replacement therapy.
- Known to have a condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
- Concurrent enrollment in a therapeutic clinical trial involving novel drug therapies
- Active autoimmune disease that has required systemic treatment in past year (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, or similar treatment) is not considered a form of systemic treatment.
- Immunodeficient subjects, E.G., receiving systemic steroid therapy or any other form of immunosuppressive therapy within 30 days prior to the first dose of endocrine therapy treatment
- Concurrent use of other oncologic therapies in the adjuvant setting other than bisphosphonates
- Active or ongoing infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, active bleeding diatheses including any subjects known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness / social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
- Pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cohort 1
Pre-menopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital.
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Cohort 2
Postmenopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital.
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Cohort 3
Pre-menopausal women initiating tamoxifen after standard of care local-regional therapy after surgery +/- radiation.
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Cohort 4
Pre-menopausal women initiating ovarian suppression plus aromatase inhibition after surgery +/- radiation.
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Cohort 5
Postmenopausal women initiating endocrine therapy with aromatase inhibition after standard of care surgery +/- radiation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in estrogen levels in response to adjuvant endocrine therapy.
Time Frame: 2 years
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Phenotypic and functional characterization of T cell and B cell populations will be performed on peripheral blood mononuclear cells.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in regulatory T cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time Frame: Through study completion, approximately 1 year.
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Blood will be assessed at each time point to understand the impact of endocrine therapy on regulatory T cells.
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Through study completion, approximately 1 year.
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Changes in T cell activation/ V cell activation in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time Frame: Through study completion, approximately 1 year.
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Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell activation/ V cell activation.
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Through study completion, approximately 1 year.
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Changes in T cell exhaustion in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time Frame: Through study completion, approximately 1 year.
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Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell exhaustion.
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Through study completion, approximately 1 year.
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Changes in myeloid-derived suppressor cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Time Frame: Through study completion, approximately 1 year.
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Blood will be assess at each time point to understand the impact of endocrine therapy on myeloid-derived suppressor cells.
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Through study completion, approximately 1 year.
|
Changes in physical manifestations with the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue survey to measure response to adjuvant endocrine therapy.
Time Frame: Through study completion, approximately 1 year.
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PROMIS Fatigue quality of life survey will be given at each time point.
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Through study completion, approximately 1 year.
|
Changes in inflammatory markers with Patient-Reported Arthralgia Inventory (PRAI) to measure response to adjuvant endocrine therapy.
Time Frame: Through study completion, approximately 1 year.
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16-item Patient-Reported Arthralgia Inventory (PRAI) quality of life survey will be given at each time point.
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Through study completion, approximately 1 year.
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Assess changes in RNA express in response to endocrine therapy.
Time Frame: Through study completion, approximately 1 year.
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RNA expression of PMBCs will be performed to assess changes in gene expression due to endocrine therapy.
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Through study completion, approximately 1 year.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan Dent, MD, Duke University
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
Other Study ID Numbers
- Pro00100408
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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