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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
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.
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.
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDisease free survival
Time frame: 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.
Time frame: 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.
Time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Local recurrence rate
Time frame: 1,2,3 years
Distant metastasis rate
Time frame: 1,2,3 years
Overall survival
Time frame: 3 years
Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes
Time frame: 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
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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.
Time frame: 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.
Time frame: 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)
Time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.