Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This is a prospective, single site, randomized, double-blind Phase III clinical trial to evaluate the clinical value of Traditional Chinese Medicine in the adjuvant therapy of triple-negative breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-70 years old;
- •Pathologically confirmed stage I-III breast cancer after early breast cancer surgery, and is confirmed by histopathology to be triple negative breast cancer (estrogen receptor (ER)-negative/ progesterone receptor (PR)-negative/ human epidermal growth factor receptor 2 (HER2)-negative). HER2-negative is defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization test is required by local laboratory testing;
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; life expectancy is ≥ 6 months;
- •Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula).
- •Participant has completed the last of their post surgical radiotherapy and chemotherapy within the last 6 months before date of enrollment, and no tumor recurrence or metastasis at the time of enrollment.
- •Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
排除标准
- •Has bilateral breast cancer;
- •Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- •Has metastatic (Stage 4) breast cancer;
- •Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
- •Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
- •Patients participating in other drug related clinical trials at the same time;
- •Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
- •Has known allergy to study medication;
- •Has severe or uncontrolled infection;
- •Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
- •The researchers judged patients to be unsuitable for the study.
研究组 & 干预措施
Traditional Chinese Medicine
60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation)
干预措施: Traditional Chinese Medicine Formulation (Drug)
Placebo
60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler)
干预措施: Placebo Formulation (Drug)
结局指标
主要结局
Disease free survival
时间窗: 3 years
Difference in quality of life scores as assessed by EORTC QLQ-C30
时间窗: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Higher scores mean a better outcome. An higher scores after treatment compared to baseline mean a better outcome or improvement.
Difference in quality of life scores as assessed by EORTC QLQ-BR23
时间窗: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer quality of life questionnaire-breast cancer module 23 (QLQ-BR23). Higher scores mean a better outcome. An higher scores after treatment compared to baseline mean a better outcome or improvement.
次要结局
- Overall survival(3 years)
- Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes(2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.)
- Local recurrence rate(1,2,3 years)
- Distant metastasis rate(1,2,3 years)
- Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score(2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.)
- Difference in physical fitness evaluation by Karnofsky performance score (KPS)(2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.)
- Adverse events(2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.)
研究者
Zhimin Shao
Head of Breast Surgery Department
Fudan University