Breast CarcinomaNCT05056857
Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen
An observational study of Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Jyotika Sharma, 281-787-7774, jsharma1@mdanderson.org
Jyotika Sharma
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To examine the effect of long-term tamoxifen (TAM) treatment on excessive NET formation in breast cancer patients.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Breast Carcinoma
- Being tested
- Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo collection of blood sample
Electronic Health Record ReviewOther
Medical charts are reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection, medical chart review) | Patients undergo collection of blood samples and their medical charts are reviewed. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Jyotika Sharma, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056857
- Sponsor's protocol ID
- 2021-0491
- Other IDs
- NCI-2021-09117, 2021-0491
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No