|
研究疾病：
|
乳腺癌
|
研究疾病代码：
|
|
|
Target disease：
|
Breast cancer
|
Target disease code：
|
|
研究类型：
Study type：
|
干预性研究
Interventional study
|
研究设计：
Study design：
|
随机平行对照
randomized controlled trial(parallel group design)
|
|
研究所处阶段：
Study phase：
|
上市后药物
Post-marketing clinical trial
|
|
研究目的：
|
术后化疗是三阴性乳腺癌的重要干预治疗；然而，术后化疗不仅存在一定风险，而且三阴性乳腺癌术后患者疗效往往不佳，并且疾病的进展会影响选择手术的时间, 使其成为不可手术的乳腺癌。目前，主要应用TAC、AT及AC-T等方案进行术后化疗。而本研究前期小样本研究提示平消胶囊提高三阴性乳腺癌术后化疗的总体生存时间。基于此，本项目旨在明确平消胶囊能够作为中药治疗，增强三阴性乳腺癌患者术后化疗效果。
本项目拟初步设计真实世界研究，扩大样本量，在三阴性乳腺癌术后化疗患者中，分为应用平消胶囊组及未应用平消胶囊组，对比两组总体生存率、肿瘤相关死亡率及肿瘤复发率；并构建预测模型，评估术后化疗情况。
|
|
Objectives of Study：
|
Postoperative chemotherapy is an important intervention for triple negative breast cancer; however, postoperative chemotherapy not only has certain risks, but also has poor curative effect for triple negative breast cancer patients, and the progress of the disease will affect the choice of operation time, making it an inoperable breast cancer. At present, TAC, at and ac-t regimens are mainly used for postoperative chemotherapy. The small sample study in the early stage of this study suggests that Pingxiao capsule can improve the overall survival time of triple negative breast cancer after chemotherapy. Based on this, this project aims to make sure that Pingxiao capsule can be used as a traditional Chinese medicine treatment to enhance the effect of postoperative chemotherapy in triple negative breast cancer patients.
This project intends to design a preliminary real-world study, expand the sample size, in patients with triple negative breast cancer after chemotherapy, divided into the application of Pingxiao capsule group and the non application of Pingxiao capsule group, compared the overall survival rate, tumor related mortality and tumor recurrence rate of the two groups; and build a predictive model to evaluate the situation of postoperative chemotherapy.
|
|
药物成份或治疗方案详述：
|
|
|
Description for medicine or protocol of treatment in detail：
|
|
|
纳入标准：
|
1、组织学或细胞学证实的三阴性乳腺癌；
2、患者同意入组治疗；
3、年龄在 18-75 岁；
4、预期生存时间大于 12 周；
5、ECOG 状态评分为 0-2 分；
6、根据 RECIST 1.1 标准，至少有一个可测量病灶；
7、器官功能水平必须符合下列要求：
血液学指标：中性粒细胞绝对计数≥1.5×10^9/L，血小板计数≥80×10^9/L，血红蛋白≥ 9.0 g/dL（可以通过输血维持）；
肝功能：总胆红素≤1.5 倍正常值上限，谷丙转氨酶和谷草转氨酶≤2.5 倍正常值上限，如有肝内转移转氨酶≤5 倍正常值上限；
肾功能：肌酐≤1.25 倍正常值上限，且肌酐清除率≥60ml/min；
8、育龄期妇女必须在开始治疗前 7 天内行尿妊娠试验且结果为阴性，且不处于哺；
乳期，男性须同意在试验期间和末次给予试验药物后 8 周内采用适当的方法避孕或已手术绝育；
9、能够依从研究和随访程序；
10、患者具有理解并自愿签署知情同意书的能力。
|
|
Inclusion criteria
|
1. Triple negative breast cancer confirmed by histology or cytology;
2. The patients agreed to be treated;
3. They were 18-75 years old;
4. The expected survival time was more than 12 weeks;
5. ECoG status score was 0-2;
6. According to RECIST 1.1, there was at least one measurable lesion;
7. The organ function level must meet the following requirements:
Hematological indexes: absolute neutrophil count >= 1.5 x 10^9 / L, platelet count >= 80 x 10^9 / L, hemoglobin >= 9.0 g / dl (can be maintained by blood transfusion);
Liver function: total bilirubin <= 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase <= 2.5 times the upper limit of normal value, if there is intrahepatic transaminase <= 5 times the upper limit of normal value;
Renal function: creatinine <= 1.25 times the upper limit of normal value, and creatinine clearance rate >= 60ml / min;
8. Women of childbearing age must have urine pregnancy test within 7 days before treatment, and the result is negative, and they are not in lactation
During the lactation period, the male should agree to use appropriate contraceptive methods or have undergone surgical sterilization during the trial period and within 8 weeks after the last administration of the trial drug;
9. Ability to comply with research and follow-up procedures;
10. Patients have the ability to understand and sign informed consent voluntarily.
|
|
排除标准：
|
受试者符合下列任何一项排除标准，则没有资格参与本项研究：
1、既往进行过任何全身性抗癌治疗，包括细胞毒性药物治疗、靶向药物治疗、试验性治疗、辅助性化疗或新辅助化疗的患者（但停药 6 个月以上术后复发患者可入选）；
2、靶病灶局部既往接受过放射治疗或射频等局部治疗；
3、合并使用苯妥英钠、卡马西平、利福平、巴比妥或圣约翰草；
4、过去 5 年内患其他恶性肿瘤，除外已治愈的基底细胞癌、宫颈原位癌、手术治疗的局限性前列腺癌或手术切除的乳腺导管原位癌；
5、患者有如下一种及以上情况的：
有症状的中枢神经系统转移或有脊髓压迫的患者；
大量胸腔积液或心包积液；
任何不稳定系统性疾病（包括活动性感染、控制不佳高血压、不稳定性心绞痛、充血性心力衰竭、肝、肾或代谢性疾病）；
不能接受口服给药、需要静脉内高能营养、之前进行过影响吸收的手术、活动性消化道溃疡、慢性腹泻的患者；
已知对平消胶囊相关成分过敏；
6、研究人员认为，受试者未必能完成本研究或未必能遵守本研究的要求（由于管理方面的原因或其他原因）。
|
|
Exclusion criteria：
|
Subjects who meet any of the following exclusion criteria are not eligible to participate in the study:
1. Patients who have had any systemic anti-cancer treatment, including cytotoxic drug therapy, targeted drug therapy, experimental treatment, adjuvant chemotherapy or neoadjuvant chemotherapy (but patients with recurrence after stopping for more than 6 months can be selected);
2. The target focus was treated by radiotherapy or radio frequency;
3. Combination of phenytoin, carbamazepine, rifampin, barbital or St. John's grass;
4. Other malignant tumors have been developed in the past 5 years, except for the cured basal cell carcinoma, cervical in situ cancer, surgical treatment of localized prostate cancer or surgical resection of breast duct carcinoma in situ;
5. The patient has one or more of the following conditions:
Patients with symptomatic central nervous system metastasis or spinal cord compression;
A large number of pleural effusion or pericardial effusion;
Any unstable systemic disease (including active infection, poor control of hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic diseases);
It is impossible to accept oral administration, need high energy nutrition in vein, and have performed operations and activities that have previously affected absorption;
Patients with peptic ulcer and chronic diarrhea;
It is known that it is allergic to relevant components of Pingxiao capsule;
6. The researchers believe that subjects may not be able to complete the study or may not comply with the requirements of the study (for management reasons or other reasons).
|
|
研究实施时间：
Study execute time：
|
从From
2021-06-30
至To
2027-12-31
|
征募观察对象时间：
Recruiting time：
|
从From
2021-08-01
至To
2022-08-01
|
