RecruitingRecruiting
Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen
NCT05056857 · M.D. Anderson Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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