Breast CancerNCT05519397
Evaluation of the Role of Immune Checkpoints in Response to Breast Cancer Neoadjuvant Therapy
An observational study of Breast Cancer, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 88 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Immune checkpoint measurement
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 88 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced Breast Cancer patients who will receive neoadjuvant therapy
Who may be able to join
- Locally advanced Breast Cancer patients who will receive neoadjuvant therapy
Who cannot join
- Known immunodeficiency
- Having a primary malignancy other than breast cancer,
- Pregnancy,
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34098
About this study
Official title: Evaluation of the Role of Immune Checkpoints in Response to Breast Cancer Neoadjuvant
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.
Read more
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.
Read the detailed description
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%. While the classification of malignant breast tumors has traditionally been made according to their histological appearance, some subtypes have been defined according to their molecular features. The different behavior of tumors in the luminal group led to the need to divide this group into subtypes as luminal A and B. 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.
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.
Immune checkpoints are important molecules that are on the agenda especially after receiving the Nobel Prize in 2018 and in revealing the relationship between cancer and the immune system. Programmed Cell Death Protein-1 (PD-1) and its ligand, PD-L1, are immune checkpoints that act by inhibiting T cell receptor signal transmission and auxiliary stimuli. T cell immunoglobulin and mucin domain 3 (TIM-3) are mostly expressed on interferon-γ producing T cells, Tregs, dendritic cells, B cells, macrophages, natural killer cells (NK) and mast cells.
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. Although many studies have been conducted on immune checkpoints in recent years, a limited number of immune checkpoints which are expressed on the cell surface have been evaluated in each study. 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.
- Conditions
- Breast Cancer
- Being tested
- Immune checkpoint measurement
- Keywords
- immune checkpoints, Locally Advanced, Neoadjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| No response | The breast cancer patients with no response to neoadjuvant therapy Receives: Diagnostic Test: Immune checkpoint measurement | |
| Moderate response | The breast cancer patients with moderate response to neoadjuvant therapy Receives: Diagnostic Test: Immune checkpoint measurement | |
| Good response | The breast cancer patients with good response to neoadjuvant therapy Receives: Diagnostic Test: Immune checkpoint measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Istanbul Training and Research Hospital
- Investigators
- Ufuk Oguz Idiz, Assoc. Prof, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519397
- Sponsor's protocol ID
- Breast cancer neoadjuvant
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30482248Li 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.
PubMed 31176611Gershtein 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.
PubMed 35192751
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Immune Checkpoints in Response to Breast Cancer Neoadjuvant
- ClinicalTrials.gov ID
- NCT05519397
- Acronym / sponsor ID
- Breast cancer neoadjuvant
- Conditions
- Breast Cancer
- Keywords
- immune checkpoints, Locally Advanced, Neoadjuvant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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%. While the classification of malignant breast tumors has traditionally been made according to their histological appearance, some subtypes have been defined according to their molecular features. The different behavior of tumors in the luminal group led to the need to divide this group into subtypes as luminal A and B. 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.
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.
Immune checkpoints are important molecules that are on the agenda especially after receiving the Nobel Prize in 2018 and in revealing the relationship between cancer and the immune system. Programmed Cell Death Protein-1 (PD-1) and its ligand, PD-L1, are immune checkpoints that act by inhibiting T cell receptor signal transmission and auxiliary stimuli. T cell immunoglobulin and mucin domain 3 (TIM-3) are mostly expressed on interferon-γ producing T cells, Tregs, dendritic cells, B cells, macrophages, natural killer cells (NK) and mast cells.
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. Although many studies have been conducted on immune checkpoints in recent years, a limited number of immune checkpoints which are expressed on the cell surface have been evaluated in each study. 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No response | – | Diagnostic Test: Immune checkpoint measurementThe breast cancer patients with no response to neoadjuvant therapy |
| Moderate response | – | Diagnostic Test: Immune checkpoint measurementThe breast cancer patients with moderate response to neoadjuvant therapy |
| Good response | – | Diagnostic Test: Immune checkpoint measurementThe breast cancer patients with good response to neoadjuvant therapy |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced Breast Cancer patients who will receive neoadjuvant therapy
Key inclusion criteria (1 listed)
- Locally advanced Breast Cancer patients who will receive neoadjuvant therapy
Key exclusion criteria (4 listed)
- Known immunodeficiency
- Having a primary malignancy other than breast cancer,
- Pregnancy,
- Patients who refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune checkpoint measurementMeasurement 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 | Diagnostic test | Good response, Moderate response, No response |
Primary outcome
Immune checkpoints
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 30482248Gu 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.
- Background: PubMed 31176611Li 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.
- Background: PubMed 35192751Gershtein 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ufuk Oguz Idiz, Assoc. Prof principal investigator
Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune checkpoints (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519397, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.