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Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen

Neutrophil Functions in Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "OUTLINE: Patients undergo collection of blood samples and their medical charts are reviewed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the long-term effects of tamoxifen on infection-fighting webs made by immune cells, called NETs. Researchers want to learn if extra NETs may harm people with breast cancer or cause side effects. The study is for women with ER-positive breast cancer who take tamoxifen.

This study examines the long-term effects of tamoxifen (TAM) treatment on excessive production of neutrophil extracellular traps (NET) and their impact on breast cancer and side effects. NET are produced by the body to fight infections but have also been linked to side effects caused by the body's immune system. Treatment with tamoxifen increases the production of NETs. This study may help researchers determine if the increased number of NETs in the body has a damaging effect in breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are female.
  • For the group before menopause: you are ages 18–45, or ages 46–50 if your periods have not stopped for 12 months in a row.
  • For the menopause group: you are age 51 or older. Menopause means your periods have stopped for 12 months in a row.
  • You have ER-positive breast cancer, which means the cancer has proteins that attach to the hormone estrogen.
  • For the main study group: you have taken tamoxifen for at least 6 months.
  • For the comparison group: you are newly diagnosed with ER-positive breast cancer and have taken tamoxifen for 0–6 months. The same age rules apply.

Who can't join

  • You are pregnant.
  • You have a history of severe congenital neutropenia: very low levels of certain infection-fighting white blood cells caused by a genetic disorder. This rule does not include myelodysplastic syndrome or acute or chronic myeloid leukemia.
  • You have a history of an autoimmune disorder, where the immune system attacks the body, such as rheumatoid arthritis, lupus, Crohn’s disease, multiple sclerosis, or psoriasis.
  • You have a history of a long-lasting viral infection, such as HIV or hepatitis.
  • You recently tested positive for COVID.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

TX