Examining the effects of tamoxifen on immune response in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the long-term effects of tamoxifen treatment on the formation of neutrophil extracellular traps (NETs) in breast cancer patients. It aims to understand how tamoxifen influences NET production and its potential implications for cancer progression and treatment side effects. Blood samples will be collected from participants, and their medical records will be reviewed to correlate NET levels with clinical outcomes, including drug resistance and metastasis. The study also includes a control group of newly diagnosed patients receiving tamoxifen for a shorter duration.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Jyotika Sharma — M.D. Anderson Cancer Center
• Study coordinator: Jyotika Sharma
• Email: jsharma1@mdanderson.org
• Phone: 281-787-7774

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.