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

STATUS

Recruiting
participants needed

200
sponsor

Fudan University

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Updated on 19 February 2024

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cancer

estrogen

blood transfusion

breast cancer

platelet count

epidermal growth factor receptor

metastasis

neutrophil count

growth factor

progesterone

immunohistochemistry

progesterone receptor

triple-negative breast cancer

triple negative breast cancer

adjuvant therapy

traditional chinese medicine

creatinine clearance rate

adjuvant

HER2

oestrogen receptor

Summary

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.

Details

Condition	Breast Cancer, Breast Cancer, Breast Cancer - HER2 Positive, Chronic Shoulder Pain
Age	18-70 years
Treatment	Traditional Chinese Medicine Formulation, Placebo Formulation
Clinical Study Identifier	NCT04403529
Sponsor	Fudan University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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) 3upper limit of normal (ULN), Aspartate Aminotransferase (AST) 3ULN, Total Bilirubin (TBIL) 1.5ULN, serum creatinine 1ULNand 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

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