Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05056857
Collaborator
National Cancer Institute (NCI) (NIH), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
280
Enrollment
1
Location
25
Anticipated Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Biospecimen Collection
  • Other: Electronic Health Record Review

Detailed Description

PRIMARY OBJECTIVE:
  1. To examine the effect of long-term tamoxifen (TAM) treatment on excessive NET formation in breast cancer patients.
SECONDARY OBJECTIVES:
  1. 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.

  2. To correlate the extend of NET formation with clinical data on tamoxifen resistance, drug side-effects, cancer metastasis and comorbidities.

EXPLORATORY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
280 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Neutrophil Functions in Breast Cancer
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Observational (biospecimen collection, medical chart review)

Patients undergo collection of blood samples and their medical charts are reviewed.

Procedure: Biospecimen Collection
Undergo collection of blood sample
Other Names:
  • Biological Sample Collection
  • Other: Electronic Health Record Review
    Medical charts are reviewed

    Outcome Measures

    Primary Outcome Measures

    1. 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]

      Percent of NET-forming neutrophils is deduced in each sample by quantitative method standardized in the lab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1M D Anderson Cancer CenterHoustonTexasUnited States77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Jyotika Sharma, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05056857
    Other Study ID Numbers:
    • 2021-0491
    • NCI-2021-09117
    • 2021-0491
    First Posted:
    Sep 27, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021