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 16 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 18years - 70years
Treatment Traditional Chinese Medicine Formulation, Placebo Formulation
Clinical Study IdentifierNCT04403529
SponsorFudan University
Last Modified on16 February 2024

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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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

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