Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen

Launched by M.D. ANDERSON CANCER CENTER · Sep 24, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how tamoxifen, a medication commonly used to treat certain types of breast cancer, affects the body’s immune response, specifically the formation of neutrophil extracellular traps (NETs). NETs are structures that help the body fight infections, but they can also cause side effects. Researchers want to find out if taking tamoxifen for a longer time leads to higher levels of NETs and whether this has any negative effects on breast cancer treatment or side effects experienced by the patients.

To participate in this study, you need to be a female diagnosed with estrogen receptor-positive (ER+) breast cancer and have been on tamoxifen for at least six months. If you are newly diagnosed and have just started tamoxifen, you may also be eligible. The study is open to women aged 18 and older, with specific age criteria depending on whether you are pre-menopausal or menopausal. Participants will be closely monitored to understand how tamoxifen affects the levels of NETs in the body. If you're considering joining, it’s important to know that certain health conditions, like pregnancy or autoimmune disorders, may exclude you from participating.

Gender

FEMALE

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