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

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Fudan University

Status and phase

Enrolling
Phase 3

Conditions

Triple Negative Breast Cancer

Treatments

Drug: Placebo Formulation
Drug: Traditional Chinese Medicine Formulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04403529
ZY(2018-2020)-CCCX-2005-04

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups, including a placebo group

Traditional Chinese Medicine
Experimental group
Description:
60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation)
Treatment:
Drug: Traditional Chinese Medicine Formulation
Placebo
Placebo Comparator group
Description:
60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler)
Treatment:
Drug: Placebo Formulation

Trial contacts and locations

1

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Central trial contact

ZhiMin Shao, MD, PhD

Data sourced from clinicaltrials.gov

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