Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen

April 29, 2026 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Jyotika Sharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pre-menopausal and post-menopausal women diagnosed with estrogen receptor positive (ER+) breast cancer being treated with tamoxifen for at least 6 months.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of neutrophil extracellular traps (NETs) in blood samples of pre- and postmenopausal women being treated with tamoxifen for varying periods of time.
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0491 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-09117 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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