Clinical trial NCT04403529: Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
Official title: Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Keywords: adjuvant therapy
traditional chinese medicine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival
timeFrame: 3 years
measure: Difference in quality of life scores as assessed by EORTC QLQ-C30
timeFrame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
measure: Difference in quality of life scores as assessed by EORTC QLQ-BR23
timeFrame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Secondary outcomes:
measure: Local recurrence rate
timeFrame: 1,2,3 years
measure: Distant metastasis rate
timeFrame: 1,2,3 years
measure: Overall survival
timeFrame: 3 years
measure: Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes
timeFrame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
measure: Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score
timeFrame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
measure: Difference in physical fitness evaluation by Karnofsky performance score (KPS)
timeFrame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
measure: Adverse events
timeFrame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: ZhiMin Shao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: