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

NCT03719495 | Completed

• 1 other identifier: Pro00100408
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Estrogen Receptor-positive Breast Cancer; Healthy

Outcome Measures

Primary Outcomes (1)

• Changes in estrogen levels in response to adjuvant endocrine therapy.

  Phenotypic and functional characterization of T cell and B cell populations will be performed on peripheral blood mononuclear cells.

  2 years

Secondary Outcomes (7)

• Changes in regulatory T cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.

  Through study completion, approximately 1 year.

• Changes in T cell activation/ V cell activation in premenopausal vs postmenopausal women treated with aromatase inhibitors.

  Through study completion, approximately 1 year.

• Changes in T cell exhaustion in premenopausal vs postmenopausal women treated with aromatase inhibitors.

  Through study completion, approximately 1 year.

• Changes in myeloid-derived suppressor cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.

  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.

  Through study completion, approximately 1 year.

Study Arms (5)

Cohort 1

Pre-menopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital.

Cohort 2

Postmenopausal women as healthy controls will be recruited on Duke University Campus and Duke University Hospital.

Cohort 3

Pre-menopausal women initiating tamoxifen after standard of care local-regional therapy after surgery +/- radiation.

Cohort 4

Pre-menopausal women initiating ovarian suppression plus aromatase inhibition after surgery +/- radiation.

Cohort 5

Postmenopausal women initiating endocrine therapy with aromatase inhibition after standard of care surgery +/- radiation.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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.
• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and archival tumor tissue.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susan Dent, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 25, 2018
• Study Start: June 19, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)