T-Cell DysfunctionSTFREiYTNBCNCT06684054
Studying the Senescent T Cell Features and Its Relationship with the Chemotherapy Efficacy in Young TNBC
An observational study of T-Cell Dysfunction and Chemotherapy Effect, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The goal of this observational study is to learn about the features of senescent T lymphocytes induced by chemotherapy and its relationship with the efficacy of neoadjuvant chemotherapy in young triple-negative breast cancer (TNBC) patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- T-Cell Dysfunction, Chemotherapy Effect, Adverse Events
- What is being tested?
- docetaxel, anthracycline, cyclophosphamide
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: young triple negative breast cancer patients receiving neoadjuvant chemotherapy
Who may be able to join
- Female, age≤40 years old,
- Invasive breast cancer confirmed by pathology, immunohistochemistry showed TNBC (ER-, PR-, HER2-),
- Indications for neoadjuvant chemotherapy according to guidelines: tumor diameter > 2cm or with axillary lymph node metastasis or desiring breast-conserving surgery but should obtain negative surgical margins through neoadjuvant chemotherapy.
Who cannot join
- Stage IV patients or a history of other malignancies,
- Having microbial infection or autoimmune disease have not been cured or having HBV, HIV infection,
- Having surgery 3 months before enrollment,
- Patients with insufficient clinicopathological data,
- Does not meet the indications for neoadjuvant chemotherapy or is unwilling to cooperate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of the Features of Senescent T Lymphocytes Induced by Chemotherapy and Its Relationship with the Efficacy of Neoadjuvant Chemotherapy in Young Triple-negative Breast Cancer Patients, a Single-center, Observational Study.
The goal of this observational study is to learn about the features of senescent T lymphocytes induced by chemotherapy and its relationship with the efficacy of neoadjuvant chemotherapy in young triple-negative breast cancer (TNBC) patients.
The main questions it aims to answer are:
Read more
- What are the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy?
- What is the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes?
- Participants will receive 6 cycles of docetaxel + adriamycin/epirubicin + cyclophosphamide (TEC/TAC) neoadjuvant chemotherapy, and radical mastectomy after chemotherapy.
2.5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery.
3.Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study.
Read the detailed description
This is a single-center observational study that is expected to enroll 30 breast cancer patients and 10 controls from July 2023 to June 2026. We mainly want to investigated senescent T lymphocytes characteristics during neoadjuvant chemotherapy in young triple-negative breast cancer patients. Besides, the relationship between senescent T lymphocytes and neoadjuvant chemotherapy efficacy also of concern to us.
Inclusion criteria: (1) female, age ≤40 years old; (2) Invasive breast cancer was confirmed by puncture pathology and TNBC (ER-, PR-, HER2-) was confirmed by immunohistochemistry; (3) Patients who meet the indications of neoadjuvant chemotherapy prescribed in the guidelines.
Exclusion criteria: (1) IV patient or history of other malignant tumors; (2) Recently infection or autoimmune disease is not cured or HBV, HIV positive; (3) Had a history of surgery 3 months before enrollment; (4) Patients with insufficient clinicopathological data; (5) Those who do not meet the evidence of neoadjuvant chemotherapy or are unwilling to cooperate.
Withdrawal criteria: (1) the subjects did not receive radical surgery in our hospital or were unwilling to continue to participate in the follow-up study; (2) Termination of chemotherapy due to serious side effects or disease progression during chemotherapy; (3) Research data related to the experiment is missing and cannot be supplemented; (4) Poor specimen quality (hemolysis, contamination, etc.); (5) Follow-up lost.
Participants will receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy after chemotherapy. Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study. 5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery. The senescence phenotype of T lymphocytes will be determined by flow cytometry.
The main purpose are:
- Studying the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy.
- Studying the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes.
- Conditions
- T-Cell Dysfunction, Chemotherapy Effect, Adverse Events
- Being tested
- docetaxel, anthracycline, cyclophosphamide
- Keywords
- breast cancer, senescence, chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel, anthracycline, cyclophosphamideDrug
Also called G-CSF
- Participants were required to receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy was required after chemotherapy.
- 5ml peripheral venous blood was collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery.
- Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study.
| Study group | Role | What they receive |
|---|---|---|
| NAC group | Participants will receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy after chemotherapy. Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study. 5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery. Receives: Drug: docetaxel, anthracycline, cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pathological complete response
Measured: 2024/7-2027/6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell DysfunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684054
- Sponsor's protocol ID
- 2023-LCYJ-PY-12
- Acronym
- STFREiYTNBC
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Features of Senescent T Lymphocytes Induced by Chemotherapy and Its Relationship with the Efficacy of Neoadjuvant Chemotherapy in Young Triple-negative Breast Cancer Patients, a Single-center, Observational Study.
- ClinicalTrials.gov ID
- NCT06684054
- Acronym / sponsor ID
- STFREiYTNBC / 2023-LCYJ-PY-12
- Conditions
- T-Cell Dysfunction, Chemotherapy Effect, Adverse Events
- Keywords
- breast cancer, senescence, chemotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
The goal of this observational study is to learn about the features of senescent T lymphocytes induced by chemotherapy and its relationship with the efficacy of neoadjuvant chemotherapy in young triple-negative breast cancer (TNBC) patients.
The main questions it aims to answer are:
- What are the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy?
- What is the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes?
- Participants will receive 6 cycles of docetaxel + adriamycin/epirubicin + cyclophosphamide (TEC/TAC) neoadjuvant chemotherapy, and radical mastectomy after chemotherapy.
2.5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery.
3.Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study.
Detailed description
This is a single-center observational study that is expected to enroll 30 breast cancer patients and 10 controls from July 2023 to June 2026. We mainly want to investigated senescent T lymphocytes characteristics during neoadjuvant chemotherapy in young triple-negative breast cancer patients. Besides, the relationship between senescent T lymphocytes and neoadjuvant chemotherapy efficacy also of concern to us.
Inclusion criteria: (1) female, age ≤40 years old; (2) Invasive breast cancer was confirmed by puncture pathology and TNBC (ER-, PR-, HER2-) was confirmed by immunohistochemistry; (3) Patients who meet the indications of neoadjuvant chemotherapy prescribed in the guidelines.
Exclusion criteria: (1) IV patient or history of other malignant tumors; (2) Recently infection or autoimmune disease is not cured or HBV, HIV positive; (3) Had a history of surgery 3 months before enrollment; (4) Patients with insufficient clinicopathological data; (5) Those who do not meet the evidence of neoadjuvant chemotherapy or are unwilling to cooperate.
Withdrawal criteria: (1) the subjects did not receive radical surgery in our hospital or were unwilling to continue to participate in the follow-up study; (2) Termination of chemotherapy due to serious side effects or disease progression during chemotherapy; (3) Research data related to the experiment is missing and cannot be supplemented; (4) Poor specimen quality (hemolysis, contamination, etc.); (5) Follow-up lost.
Participants will receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy after chemotherapy. Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study. 5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery. The senescence phenotype of T lymphocytes will be determined by flow cytometry.
The main purpose are:
- Studying the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy.
- Studying the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAC group | – | Drug: docetaxel, anthracycline, cyclophosphamideParticipants will receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy after chemotherapy. Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study. 5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young triple negative breast cancer patients receiving neoadjuvant chemotherapy
Key inclusion criteria (3 listed)
- Female, age≤40 years old,
- Invasive breast cancer confirmed by pathology, immunohistochemistry showed TNBC (ER-, PR-, HER2-),
- Indications for neoadjuvant chemotherapy according to guidelines: tumor diameter > 2cm or with axillary lymph node metastasis or desiring breast-conserving surgery but should obtain negative surgical margins through neoadjuvant chemotherapy.
Key exclusion criteria (5 listed)
- Stage IV patients or a history of other malignancies,
- Having microbial infection or autoimmune disease have not been cured or having HBV, HIV infection,
- Having surgery 3 months before enrollment,
- Patients with insufficient clinicopathological data,
- Does not meet the indications for neoadjuvant chemotherapy or is unwilling to cooperate.
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 |
|---|---|---|
| docetaxel, anthracycline, cyclophosphamideAlso: G-CSF1. Participants were required to receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy was required after chemotherapy. 2. 5ml peripheral venous blood was collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery. 3. Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study. | Drug | NAC group |
Primary outcome
pCR
Time frame: 2024/7-2027/6
pathological complete response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of T-Cell Dysfunction and Chemotherapy Effect, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang (0086-15850582852, njmuwangwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: 2024/7-2027/6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.