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Observational Study of Neutrophil Traps in Breast Cancer Patients Taking Tamoxifen

This study is looking at how tamoxifen, a common breast cancer treatment, affects the body's production of neutrophil extracellular traps (NETs). NETs are usually made to fight infections, but they might also be linked to side effects and how breast cancer progresses. Researchers will collect blood samples from women with breast cancer who are taking tamoxifen, both before and after menopause, and review their medical records. The goal is to understand if increased NETs due to tamoxifen have a harmful effect. This is an observational study, meaning you won't receive new treatments, and it aims to enroll 290 participants. The study status is currently unclear.

Study design
This is an observational study with a planned enrollment of 290 women. It is not a treatment study, but rather looks at existing treatments and their effects.
What's involved
You would provide a blood sample and your medical charts would be reviewed. This will happen over an average of one year.
Compensation
Not stated in the trial record.
Follow-up
Your blood samples will be analyzed throughout study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05056857

Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen

Recruiting
Not specifiedAges 18+Observational
M.D. Anderson Cancer Center
~290 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Biospecimen CollectionElectronic Health Record Review

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantification of neutrophil extracellular traps (NETs) in blood samples of pre- and postmenopausal women being treated with tamoxifen for varying periods of time.
Measured over through study completion, an average of 1 year

Conditions

Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jyotika Sharma · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Jyotika Sharma
[email protected]
281-787-7774
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Female
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

Pregnant -The immune modulations geared toward maintenance of pregnancy are known to cause wide-spread alterations in innate and adaptive immune cell functions. In this scenario, divorcing the pregnancy-related changes in myeloid cell function from those relevant to sepsis and cancer will be complicated.
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

What this trial measures

  • Quantification of neutrophil extracellular traps (NETs) in blood samples of pre- and postmenopausal women being treated with tamoxifen for varying periods of time.through study completion, an average of 1 year

    Percent of NET-forming neutrophils is deduced in each sample by quantitative method standardized in the lab.