Breast Carcinoma Clinical Trial
Official title:
Neutrophil Functions in Breast Cancer
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.
Status | Recruiting |
Enrollment | 280 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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: - Patient is terminal (expected survival < 6 months) - Informed consent unobtainable - 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, warts, hypogammaglobulinemia, infections, and myelokathexis (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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification of neutrophil extracellular traps (NETs) in blood samples of pre- and postmenopausal women being treated with tamoxifen for varying periods of time. | Percent of NET-forming neutrophils is deduced in each sample by quantitative method standardized in the lab. | through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04996316 -
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
|
||
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT05526872 -
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
|
N/A | |
Not yet recruiting |
NCT05178498 -
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
|
||
Recruiting |
NCT05544123 -
The Treatment Situation of Chinese County Population With Breast Cancer
|
||
Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
Completed |
NCT01422408 -
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
|
Phase 2 | |
Terminated |
NCT02810873 -
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
|
N/A | |
Terminated |
NCT00770354 -
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT03185871 -
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
|
Phase 2 | |
Completed |
NCT02983279 -
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
|
N/A | |
Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
Recruiting |
NCT05406232 -
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
|
||
Recruiting |
NCT03408353 -
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
|
||
Completed |
NCT01641068 -
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
|
N/A | |
Withdrawn |
NCT04190433 -
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
|
Phase 2 | |
Recruiting |
NCT04799535 -
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
|
||
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |