Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC

NCT07523789 | Not Yet Recruiting

• 1 other identifier: Neoadjuvant Therapy for TNBC
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational study that retrospectively collects data of triple-negative breast cancer patients who received neoadjuvant therapy. It compares the bpCR rate, apCR rate, and tpCR rate of patients treated with chemotherapy or immunotherapy, in order to analyze the efficacy and influencing factors of chemotherapy and immunotherapy in neoadjuvant therapy for triple-negative breast cancer.

Conditions

TNBC, Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  The proportion of patients who achieved pathological complete response after undergoing complete neoadjuvant therapy and subsequent surgery

  1 year

Study Arms (2)

Chemotherapy group

Patients with triple-negative breast cancer who underwent neoadjuvant chemotherapy

Immunotherapy group

Patients with triple-negative breast cancer who underwent neoadjuvant Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TNBC patients

You may qualify if:

• (1)The patient is aged ≥18 years;(2) Both the biopsy pathology and postoperative pathology confirm the diagnosis of triple-negative breast cancer; (3) The patient has undergone complete neoadjuvant therapy; (4) After neoadjuvant therapy, the patient underwent surgical treatment and has complete postoperative pathology results; (5) The patient's basic information is complete.

You may not qualify if:

• (1) Bilateral breast cancer or distant metastasis; (2) History of previous malignant tumor or chemotherapy/immunotherapy; (3) Required NST not completed or no surgical treatment after NST; (4) Lack of pathological evaluation results for biopsy specimens or postoperative specimens, or postoperative pathological results not being triple negative; (5) Unable to obtain characteristic patient information, such as age and tumor stage. (6) Change in regimen during neoadjuvant therapy; (7) Lost to follow-up patients.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jue Wang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Xiaoming Zha

CONTACT

008613952001278; njzhaxm@njmy.edu.cn

Jue Wang

CONTACT

008618061695508; wangjue200011@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)