- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04403529
Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
May 28, 2020 updated by: Zhimin Shao, Fudan University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ZhiMin Shao, MD, PhD
- Phone Number: 8808 +86-21-64175590
- Email: zhimingshao@yahoo.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Hospital
-
Contact:
- Zhi-Ming Shao, MD, PhD
- Phone Number: 8888 +86-021-64175590
- Email: zhimingshao@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Traditional Chinese Medicine
60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" 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.
Other Names:
|
Placebo Comparator: Placebo
60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler)
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival
Time Frame: 3 years
|
3 years
|
|
Difference in quality of life scores as assessed by EORTC QLQ-C30
Time Frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Higher scores mean a better outcome.
An higher scores after treatment compared to baseline mean a better outcome or improvement.
|
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Difference in quality of life scores as assessed by EORTC QLQ-BR23
Time Frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer quality of life questionnaire-breast cancer module 23 (QLQ-BR23).
Higher scores mean a better outcome.
An higher scores after treatment compared to baseline mean a better outcome or improvement.
|
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 3 years
|
3 years
|
|
Local recurrence rate
Time Frame: 1,2,3 years
|
1,2,3 years
|
|
Distant metastasis rate
Time Frame: 1,2,3 years
|
1,2,3 years
|
|
Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes
Time Frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
|
Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score
Time Frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score, the score runs from 0 to 5, with 0 denoting perfect health and 5 death.
|
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Difference in physical fitness evaluation by Karnofsky performance score (KPS)
Time Frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Difference in physical fitness evaluation by Karnofsky performance score (KPS), the score runs from 0 to 100, with 100 denoting perfect health and 0 death.
|
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Adverse events
Time Frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Incidence and Severity of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0(CTCAE V4.0)
|
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2020
Primary Completion (Anticipated)
May 31, 2024
Study Completion (Anticipated)
May 31, 2024
Study Registration Dates
First Submitted
May 20, 2020
First Submitted That Met QC Criteria
May 24, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Actual)
June 1, 2020
Last Update Submitted That Met QC Criteria
May 28, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZY(2018-2020)-CCCX-2005-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Triple Negative Breast Cancer
-
Peregrine PharmaceuticalsWithdrawnBreast Cancer | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | Triple-Negative Breast Cancer | Triple-Negative Breast Neoplasm | ER-Negative PR-Negative HER2-Negative Breast Neoplasms | ER-Negative PR-Negative HER2-Negative Breast Cancer
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); MedImmune...TerminatedTriple Negative Breast Cancer | Triple Negative Breast Neoplasms | TNBC - Triple-Negative Breast Cancer | Triple-negative Breast CarcinomaUnited States
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
AkesoRecruitingMetastatic Triple-negative Breast Cancer | Locally Advanced Triple-negative Breast CancerChina
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
Fudan UniversityRecruitingTriple-Negative Breast CancerChina
-
Fudan UniversityRecruiting
-
Fudan UniversityRecruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingBreast Cancer | Triple-Negative Breast CancerChina
-
Fudan UniversityRecruiting
Clinical Trials on Traditional Chinese Medicine Formulation
-
First Affiliated Hospital Xi'an Jiaotong UniversityNot yet recruiting
-
Henan University of Traditional Chinese MedicineUnknownCommunity-acquired PneumoniaChina
-
Qianfoshan HospitalNot yet recruitingHepatic Encephalopathy | Cirrhosis, Liver | Portosystemic ShuntChina
-
Xiyuan Hospital of China Academy of Chinese Medical...Beijing Municipal Science & Technology CommissionUnknownAdvanced Colorectal Cancer | Traditional Chinese MedicineChina
-
Shengjing HospitalRecruitingPlasma Cell MastitisChina
-
Taipei Veterans General Hospital, TaiwanWithdrawnRheumatoid Arthritis | Systemic Lupus Erythematosus | Systemic Sclerosis | Dry Eye Syndrome | Sjögren's Syndrome | Ankylosing SpondylitisTaiwan
-
Tianjin Medical University Cancer Institute and...RecruitingDiarrhea Caused by Antitumor DrugsChina
-
Sheng LiuUnknownRecurrence | Overall Survival | Progression-Free-SurvivalChina
-
National Center for Complementary and Integrative...CompletedTemporomandibular Joint DisordersUnited States
-
Chinese University of Hong KongUniversity of Maryland; National Center for Complementary and Integrative Health...CompletedIrritable Bowel SyndromeChina