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Evaluation of Endocrine Therapy Effects of Host Immunity in Early Stage Breast Cancer | Clinical Trials | Clareo Health

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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

NCT03719495•Duke University

View on ClinicalTrials.gov

Summary

The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.

Detailed Description

The study will enroll mainly subjects with estrogen receptor positive breast cancer that have completed surgery and radiation therapy to remove the tumor(s) and have not yet started standard treatment endocrine therapy. There is one group of subjects who have not been diagnosed with cancer. The information learned from this study will help doctors understand more about how the immune system responds to endocrine therapy for early stage breast cancer in people who are estrogen receptor positive with the goal of developing improved therapies that harness the immune system.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. No known significant health problems.
•2. Available to participate for the planned duration of the investigational study (6 months).
•3. Able and willing to complete the informed consent process.
•4. Agree to have blood stored for future studies.
•5. Premenopausal women must have a history of regular menses defined as occuring monthly at regular intervals.
•6. 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
+16 more criteria

Exclusion Criteria

•1. Relapsed or metastatic breast cancer.
•2. History of cancer or concurrent active malignancy (excluding basal cell skin cancer, resected squamous cell carcinoma of the skin).
•3. Receipt of neoadjuvant or previous endocrine therapy including ovarian function suppression in the neoadjuvant setting.
•4. Current use of hormonal birth control (copper IUD allowed) or estrogen replacement therapy.
•5. 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.
•6. Concurrent enrollment in a therapeutic clinical trial involving novel drug therapies
•7. 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.
•8. 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
•9. Concurrent use of other oncologic therapies in the adjuvant setting other than bisphosphonates
•10. Active or ongoing infection
+2 more criteria

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Key Dates

Start Date

June 19, 2019

Primary Completion Date

July 31, 2023

Completion Date

July 31, 2023

Last Updated

May 16, 2024

Enrollment

ACTUAL participants

Conditions

Breast CancerEstrogen Receptor-positive Breast CancerHealthy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Endocrine Therapy Effects of Host Immunity in Early Stage Breast Cancer

Inclusion Criteria

Exclusion Criteria

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