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Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen

NCT05056857 · M.D. Anderson Cancer Center
In plain English

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Official title
Neutrophil Functions in Breast Cancer
About this study
PRIMARY OBJECTIVE: 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.
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 design
Enrollment target: 290 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-10-01
Estimated completion: 2026-10-31
Last updated: 2026-05-01
Interventions
Procedure: Biospecimen CollectionOther: Electronic Health Record Review
Primary outcomes
  • 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)
Sponsor
M.D. Anderson Cancer Center · other
With: National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)
Contacts & investigators
ContactJyotika Sharma · contact · jsharma1@mdanderson.org · 281-787-7774
InvestigatorJyotika Sharma · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States
Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen · TrialPath