Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
NCT ID: NCT04403529
Last Updated: 2020-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2020-05-25
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Traditional Chinese Medicine
60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation)
Traditional Chinese Medicine Formulation
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
60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler)
Placebo Formulation
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.
Interventions
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Traditional Chinese Medicine Formulation
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 Formulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Head of Breast Surgery Department
Principal Investigators
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ZhiMin Shao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZY(2018-2020)-CCCX-2005-04
Identifier Type: -
Identifier Source: org_study_id
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