跳至主要内容
临床试验/NCT07523789
NCT07523789尚未招募不适用

Analysis of the Efficacy and Influencing Factors of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for Triple-Negative Breast Cancer

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
201
试验地点
1
主要终点
Pathological complete response rate

研究概览

简要总结

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.

详细描述

Breast cancer is one of the most common malignant tumors in women, with a rapidly increasing incidence rate and mortality rate globally. Triple-negative breast cancer (TNBC) refers to a type of breast cancer that lacks amplification of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2), accounting for approximately 15% to 20% of all breast cancer types. It is characterized by high aggressiveness, rapid recurrence and metastasis, difficult treatment, and high mortality rate. The main treatment methods for TNBC include chemotherapy, surgery, and neoadjuvant therapy. Neoadjuvant therapy is an important component of TNBC treatment, which can rapidly control tumor burden, reduce the risk of distant metastasis, increase surgical opportunities, and facilitate preoperative assessment of tumor response to drugs, thereby evaluating the effectiveness of treatment regimens and guiding the selection of postoperative treatment plans. Currently, the standard neoadjuvant therapy regimen for TNBC is based on chemotherapy combined with immunotherapy or targeted therapy.

In recent years, the application of immunotherapy in triple-negative breast cancer has gained increasing attention. Based on the phase III clinical study KEYNOTE-522, the PD-1 inhibitor pembrolizumab has been approved for neoadjuvant and adjuvant therapy of triple-negative breast cancer.

Preliminary data from the KEYNOTE-522 study indicate that, in neoadjuvant therapy, the combination of pembrolizumab significantly improves the pathologic complete response (pCR) rate and 3-year event-free survival (EFS) rate compared to chemotherapy alone. The study results suggest that immunotherapy has advantages in improving the prognosis of triple-negative breast cancer.

This study retrospectively collected data on triple-negative breast cancer patients who received neoadjuvant therapy based on inclusion and exclusion criteria, including complete data on diagnosis age, clinical tumor stage, clinical lymph node stage, Ki-67 level, HER-2 expression, surgical method after neoadjuvant therapy, and postoperative pathology. The study categorized neoadjuvant efficacy into breast pathological complete response, axillary pathological complete response, and overall pathological complete response. It compared and analyzed the bpCR rate, apCR rate, and tpCR rate of patients with different clinical characteristics to evaluate the efficacy of chemotherapy and immunotherapy in neoadjuvant therapy for triple-negative breast cancer. Binary logistic regression analysis was used to investigate the influencing factors of neoadjuvant efficacy. Additionally, this study established a set of subgroup analyses to explore the efficacy and influencing factors of albumin-bound paclitaxel weekly therapy and three-week therapy in immunotherapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • (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.

排除标准

  • (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.

研究组 & 干预措施

Chemotherapy group

Patients with triple-negative breast cancer who underwent neoadjuvant chemotherapy

Immunotherapy group

Patients with triple-negative breast cancer who underwent neoadjuvant Immunotherapy

结局指标

主要结局

Pathological complete response rate

时间窗: 1 year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jue Wang

Prof.

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

Loading locations...

相似试验