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

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

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Hospital
        • Contact:

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:
  • "prescription for breast cancer" Traditional Chinese Medicine formulation
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:
  • Placebo granules contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler

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.

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

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

Clinical Trials on Traditional Chinese Medicine Formulation

3
Subscribe