Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Traditional Chinese Medicine Formulation
* Drug: Placebo Formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Chinese Medicine<br>60 days of oral Traditional Chinese Medicine (prescription for breast cancer Traditional Chinese Medicine formulation) | Drug: Traditional Chinese Medicine Formulation<br>* The prescription for breast cancer Traditional Chinese Medicine formulation is a combination of 12 herbal components and it is available in granules form to be dissolved in hot water for consumption.<br>* Other names: prescription for breast cancer Traditional Chinese Medicine formulation;|
| Placebo Comparator: Placebo<br>60 days of oral placebo (placebo contains 5% prescription for breast cancer Traditional Chinese Medicine formulation and 95% filler) | Drug: Placebo Formulation<br>* Placebo granules contains 5% prescription for breast cancer Traditional Chinese Medicine formulation and 95% filler, it is available in granules form to be dissolved in hot water for consumption.<br>* Other names: Placebo granules contains 5% prescription for breast cancer Traditional Chinese Medicine formulation and 95% filler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 3 years | 
| Difference in quality of life scores as assessed by EORTC QLQ-C30 | 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. | 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 EORTC QLQ-BR23 | 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. | 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence rate |  | 1,2,3 years | 
| Distant metastasis rate |  | 1,2,3 years | 
| 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. | 
| Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score | Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score, the score runs from 0 to 5, with 0 denoting perfect health and 5 death. | 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) | Difference in physical fitness evaluation by Karnofsky performance score (KPS), the score runs from 0 to 100, with 100 denoting perfect health and 0 death. | 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years. | 
| Adverse events | Incidence and Severity of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0（CTCAE V4.0） | 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant therapy, traditional chinese medicine