Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
Primary Purpose
Triple Negative Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Traditional Chinese Medicine Formulation
Placebo Formulation
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring adjuvant therapy, traditional chinese medicine
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.
Sites / Locations
- Fudan University Shanghai Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Traditional Chinese Medicine
Placebo
Arm Description
60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation)
60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler)
Outcomes
Primary Outcome Measures
Disease free survival
Difference in quality of life scores as assessed by EORTC QLQ-C30
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.
Difference in quality of life scores as assessed by EORTC QLQ-BR23
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.
Secondary Outcome Measures
Local recurrence rate
Distant metastasis rate
Overall survival
Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes
Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score
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.
Difference in physical fitness evaluation by Karnofsky performance score (KPS)
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.
Adverse events
Incidence and Severity of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0(CTCAE V4.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04403529
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
adjuvant therapy, traditional chinese medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional Chinese Medicine
Arm Type
Experimental
Arm Description
60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler)
Intervention Type
Drug
Intervention Name(s)
Traditional Chinese Medicine Formulation
Other Intervention Name(s)
"prescription for breast cancer" Traditional Chinese Medicine formulation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Formulation
Other Intervention Name(s)
Placebo granules contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
3 years
Title
Difference in quality of life scores as assessed by EORTC QLQ-C30
Description
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.
Time Frame
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Title
Difference in quality of life scores as assessed by EORTC QLQ-BR23
Description
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.
Time Frame
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Secondary Outcome Measure Information:
Title
Local recurrence rate
Time Frame
1,2,3 years
Title
Distant metastasis rate
Time Frame
1,2,3 years
Title
Overall survival
Time Frame
3 years
Title
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.
Title
Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score
Description
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.
Time Frame
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Title
Difference in physical fitness evaluation by Karnofsky performance score (KPS)
Description
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.
Time Frame
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Title
Adverse events
Description
Incidence and Severity of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0(CTCAE V4.0)
Time Frame
2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZhiMin Shao, MD, PhD
Phone
+86-21-64175590
Ext
8808
Email
zhimingshao@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZhiMin Shao, MD, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Ming Shao, MD, PhD
Phone
+86-021-64175590
Ext
8888
Email
zhimingshao@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
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