NCT05460702

Brief Summary

Breast cancer is the most common type of cancer in women and the second most common cause of death after lung cancer. The luminal group A, which has the highest prevalence among breast cancers; It includes Her2-negative tumors with low proliferative activity, low mitotic rate and histological grade. The prognosis of patients with luminal A tumors is very good and metastases are mostly limited to bones. Luminal-B tumors have a more aggressive course. The most important difference of this group is that tumors have a high proliferation rate. The breakpoint between luminal A and B is generally accepted as less than 14% of tumor cells showing nuclear Ki67 expression immunohistochemically. In addition, approximately 30% of Her2-positive tumors are immunohistochemically in the luminal B phenotype. 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 few studies in the literature evaluating soluble immune checkpoints in breast cancer, and these studies did not evaluate soluble immune checkpoints according to the histopathological subtyping of breast cancer. The aim of this study is to determine the relationship between Luminal A, Luminal B and triple negative breast cancer and soluble immune control points, and to guide possible potential immunotherapy treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

May 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

July 9, 2022

Last Update Submit

February 14, 2023

Conditions

Breast Cancer

Keywords

Breast CancerImmune Checkpoints

Outcome Measures

Primary Outcomes (1)

  • Immune checkpoints

    sCD25 (pg/ml), 4-1BB (pg/ml), B7.2 (pg/ml), Free Active TGF-β1 (pg/ml), CTLA-4 (pg/ml), PD-L1 (pg/ml), PD-1 (pg/ml), Tim-3 (pg/ml), LAG-3 (pg/ml), Galectin-9 (pg/ml)

    2 weeks

Study Arms (4)

Luminal A

Breast cancer patients with immunohistochemically luminal A

Diagnostic Test: Soluble immune checkpoints

Luminal B

Breast cancer patients with immunohistochemically luminal B

Diagnostic Test: Soluble immune checkpoints

Triple negative

Breast cancer patients with immunohistochemically triple negative

Diagnostic Test: Soluble immune checkpoints

Control

The absence of any pathology in the breasts of healthy volunteers by mammography and/or ultrasound

Diagnostic Test: Soluble immune checkpoints

Interventions

Soluble immune checkpointsDIAGNOSTIC_TEST

Blood collection from breast cancer patients with stage I-II

ControlLuminal ALuminal BTriple negative

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patient with stage I-II

You may qualify if:

  • Over 18 years,
  • Patients with clinically and histopathologically proven Stage I-II breast cancer

You may not qualify if:

  • Known immunodeficiency
  • Having a primary malignancy other than breast cancer,
  • Pregnancy,
  • Patients younger than 18 years and older than 90 years,
  • Patients who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Memorial Hizmet Hospital

Istanbul, 34203, 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: 30482248RESULT

  • Fang J, Chen F, Liu D, Gu F, Chen Z, Wang Y. Prognostic value of immune checkpoint molecules in breast cancer. Biosci Rep. 2020 Jul 31;40(7):BSR20201054. doi: 10.1042/BSR20201054.

    PMID: 32602545RESULT

  • Asano Y, Kashiwagi S, Takada K, Ishihara S, Goto W, Morisaki T, Shibutani M, Tanaka H, Hirakawa K, Ohira M. Clinical Significance of Expression of Immunoadjuvant Molecules (LAG-3, TIM-3, OX-40) in Neoadjuvant Chemotherapy for Breast Cancer. Anticancer Res. 2022 Jan;42(1):125-136. doi: 10.21873/anticanres.15466.

    PMID: 34969718RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

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 CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. MD. PhD

Study Record Dates

First Submitted

July 9, 2022

First Posted

July 15, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 15, 2022

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

TU(2)