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

Completed

• Conditions: Breast Cancer; Estrogen Receptor-positive Breast Cancer; Healthy

• Registration Number: NCT03719495
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Study Start: 2019-06-19
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in estrogen levels in response to adjuvant endocrine therapy.	2 years	Phenotypic and functional characterization of T cell and B cell populations will be performed on peripheral blood mononuclear cells.

Secondary Outcome Measures

Name	Time	Method
Changes in T cell activation/ V cell activation in premenopausal vs postmenopausal women treated with aromatase inhibitors.	Through study completion, approximately 1 year.	Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell activation/ V cell activation.
Changes in T cell exhaustion in premenopausal vs postmenopausal women treated with aromatase inhibitors.	Through study completion, approximately 1 year.	Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell exhaustion.
Changes in physical manifestations with the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue survey to measure response to adjuvant endocrine therapy.	Through study completion, approximately 1 year.	PROMIS Fatigue quality of life survey will be given at each time point.
Changes in inflammatory markers with Patient-Reported Arthralgia Inventory (PRAI) to measure response to adjuvant endocrine therapy.	Through study completion, approximately 1 year.	16-item Patient-Reported Arthralgia Inventory (PRAI) quality of life survey will be given at each time point.
Changes in regulatory T cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.	Through study completion, approximately 1 year.	Blood will be assessed at each time point to understand the impact of endocrine therapy on regulatory T cells.
Changes in myeloid-derived suppressor cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.	Through study completion, approximately 1 year.	Blood will be assess at each time point to understand the impact of endocrine therapy on myeloid-derived suppressor cells.
Assess changes in RNA express in response to endocrine therapy.	Through study completion, approximately 1 year.	RNA expression of PMBCs will be performed to assess changes in gene expression due to endocrine therapy.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States