Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen
NCT ID: NCT05056857
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
290 participants
OBSERVATIONAL
2021-10-01
2026-10-31
Brief Summary
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Detailed Description
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I. To examine the effect of long-term tamoxifen (TAM) treatment on excessive NET formation in breast cancer patients.
SECONDARY OBJECTIVES:
I. To understand the molecular mechanisms of tamoxifen-induced NET formation in breast cancer patients by examining the effect of long-term TAM treatment on the NET-induced factors.
II. To correlate the extend of NET formation with clinical data on tamoxifen resistance, drug side-effects, cancer metastasis and comorbidities.
EXPLORATORY OBJECTIVE:
I. To explore the association between the extent of NET formation and clinical data for breast cancer patients treated with TAM in combination with other drugs.
OUTLINE:
Patients undergo collection of blood samples and their medical charts are reviewed.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Observational (biospecimen collection, medical chart review)
Patients undergo collection of blood samples and their medical charts are reviewed.
Biospecimen Collection
Undergo collection of blood sample
Electronic Health Record Review
Medical charts are reviewed
Interventions
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Biospecimen Collection
Undergo collection of blood sample
Electronic Health Record Review
Medical charts are reviewed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age criteria for pre-menopausal group: Equal to or greater than 18 years of age and less than or equal to 45 years of age. Patients of age 46-50 will be included if they have not had menstrual cessation for 12 consecutive months.
* Age criteria for menopausal group: At least 51 years of age (median age of menopause). Menopause is defined as cessation of menstrual cycle for 12 consecutive months.
* Diagnosed with ER+ breast cancer
* Being treated with tamoxifen (TAM) for at least 6 months
* CONTROL SUBJECTS: Newly diagnosed ER+ breast cancer patients of the same age group as above on TAM for 0-6 months. This criterion is based on our preliminary results showing that patients taking TAM for 6-7 months exhibit near baseline level of NETs
Exclusion Criteria
* History of severe congenital neutropenia due to genetic disorders, such as Kostmann Disorder (HAX1 gene mutation), ELA2 gene mutation, Wiskott-Aldrich syndrome (WAS), Growth Factor Independent 1 Protein (GFI1) gene mutation, Colony Stimulating Factor 3 Receptor (CSF3R) gene mutation, Schwachman-Diamond Syndrome, Barth Syndrome, WHIM Syndrome, and Chadiak-Higashi Syndrome (this list notably does not include Myelodysplastic Syndrome, or Acute/Chronic Myeloid Leukemia)
* History of autoimmune disorders, which can affect the body's inflammatory response, such as rheumatoid arthritis, lupus, Crohn's disease, multiple sclerosis, and psoriasis.
* History of chronic viral infections (human immunodeficiency virus \[HIV\], hepatitis), which can lead to reduced or variable immune cell function.
* A recent positive coronavirus disease (COVID) test
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jyotika Sharma
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Jyotika Sharma
Role: primary
Related Links
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M D Anderson Cancer Center
Other Identifiers
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2021-0491
Identifier Type: -
Identifier Source: org_study_id
NCI-2021-09117
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-0491
Identifier Type: OTHER
Identifier Source: secondary_id