Studying the Senescent T Cell Features and Its Relationship with the Chemotherapy Efficacy in Young TNBC

NCT06684054 | Not Yet Recruiting DMC

• 1 other identifier: 2023-LCYJ-PY-12
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

T-Cell Dysfunction; Chemotherapy Effect; Adverse Events

Keywords

breast cancer; senescence; chemotherapy

Outcome Measures

Primary Outcomes (1)

• pCR

  pathological complete response

  2024/7-2027/6

Study Arms (1)

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.

Drug: docetaxel, anthracycline, cyclophosphamide

Interventions

docetaxel, anthracycline, cyclophosphamide DRUG

1. 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.

Also known as: G-CSF

NAC group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

young triple negative breast cancer patients receiving neoadjuvant chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Biospecimen

Retention: SAMPLES WITH DNA

The collected blood and tissue samples are frozen in the -80℃ refrigerator or liquid nitrogen tank in our hospital.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Anthracyclines; Cyclophosphamide; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Wang

CONTACT

0086-15850582852; njmuwangwei@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share