Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-29 @ 3:36 AM
Study NCT ID:
NCT05056857
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Neutrophil Functions in Breast Cancer
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: