Analysis of the Efficacy and Influencing Factors of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for Triple-Negative Breast Cancer
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
- 否
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
Jue Wang
Prof.
The First Affiliated Hospital with Nanjing Medical University
