NCT05519397

Brief Summary

Breast cancer is the most common type of cancer in women and the second most common cause of death after lung cancer. In epidemiological studies, its prevalence is 22-26%, and the mortality risk due to breast cancer is around 18%. It is known that the immune system has an important role in tumor development or tumor destruction. Recent studies have shown that tumor cells acquire escape mechanisms to escape host immunity in the tumor microenvironment. Studies have reported that immune checkpoints are elevated in many types of cancer and have a poor prognosis. Up or down regulation of immune checkpoints is observed to protect breast cancer cells from the anti-tumor responses of the immune system. There are also immune checkpoints found in plasma in soluble form, and the number of studies evaluating soluble immune checkpoints in cancers is very limited in the literature. Measurement of soluble immune control points is easier than those expressed on the surface, and many markers can be evaluated at the same time. There are very few studies in the literature evaluating soluble immune checkpoints in breast cancer. The aim of this study is to investigate the role of soluble immune checkpoints in predicting the response to neoadjuvant therapy in locally advanced breast cancers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

August 25, 2022

Last Update Submit

September 7, 2023

Conditions

Breast Cancer

Keywords

immune checkpointsLocally AdvancedNeoadjuvant

Outcome Measures

Primary Outcomes (1)

  • Immune checkpoints

    Values in pg/ml of sCD25 (IL-2Ra), 4-1BB, CD27, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-L2, PD-1, Tim-3, LAG-3, Galectin-9

    1 day

Study Arms (3)

No response

The breast cancer patients with no response to neoadjuvant therapy

Diagnostic Test: Immune checkpoint measurement

Moderate response

The breast cancer patients with moderate response to neoadjuvant therapy

Diagnostic Test: Immune checkpoint measurement

Good response

The breast cancer patients with good response to neoadjuvant therapy

Diagnostic Test: Immune checkpoint measurement

Interventions

Immune checkpoint measurementDIAGNOSTIC_TEST

Measurement of sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9

Good responseModerate responseNo response

Eligibility Criteria

Age18 Years - 88 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast Cancer limited to females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Locally advanced Breast Cancer patients who will receive neoadjuvant therapy

You may qualify if:

  • Locally advanced Breast Cancer patients who will receive neoadjuvant therapy

You may not qualify if:

  • Known immunodeficiency
  • Having a primary malignancy other than breast cancer,
  • Pregnancy,
  • Patients who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

  • Gu D, Ao X, Yang Y, Chen Z, Xu X. Soluble immune checkpoints in cancer: production, function and biological significance. J Immunother Cancer. 2018 Nov 27;6(1):132. doi: 10.1186/s40425-018-0449-0.

    PMID: 30482248BACKGROUND

  • Li Y, Cui X, Yang YJ, Chen QQ, Zhong L, Zhang T, Cai RL, Miao JY, Yu SC, Zhang F. Serum sPD-1 and sPD-L1 as Biomarkers for Evaluating the Efficacy of Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Patients. Clin Breast Cancer. 2019 Oct;19(5):326-332.e1. doi: 10.1016/j.clbc.2019.03.008. Epub 2019 Apr 11.

    PMID: 31176611BACKGROUND

  • Gershtein ES, Korotkova EA, Vorotnikov IK, Sokolov NY, Ermilova VD, Mochalova AS, Kushlinskii NE. Soluble forms of PD-1/PD-L immune checkpoint receptor and ligand in blood serum of breast cancer patients: association with clinical pathologic factors and molecular type of the tumor. Klin Lab Diagn. 2022 Feb 23;67(2):76-80. doi: 10.51620/0869-2084-2022-67-2-76-80.

    PMID: 35192751BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ufuk Oguz Idiz, Assoc. Prof

    Istanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. MD. PhD

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

January 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

TU(1)