Triple Negative Breast CancerPhase 3NCT04403529
Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
A Phase 3 study testing Traditional Chinese Medicine Formulation in people with Triple Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Traditional Chinese Medicine Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2020to 31 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhi-Ming Shao, MD, PhD, +86-021-64175590 ext. 8888, zhimingshao@yahoo.com
About this study
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.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Traditional Chinese Medicine Formulation, Placebo Formulation
- Keywords
- adjuvant therapy, traditional chinese medicine
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine FormulationDrug
Also called "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.
Placebo FormulationDrug
Also called Placebo granules 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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine | Experimental | 60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation) Receives: Drug: Traditional Chinese Medicine Formulation |
| Placebo | Placebo comparator | 60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler) Receives: Drug: Placebo Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 3 years
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.
Measured: 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
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.
Measured: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Secondary outcomes (7)
Local recurrence rate
Measured: 1,2,3 years
Distant metastasis rate
Measured: 1,2,3 years
Overall survival
Measured: 3 years
Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes
Measured: 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
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.
Measured: 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)
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.
Measured: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Adverse events
Incidence and Severity of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0（CTCAE V4.0）
Measured: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start25 May 2020
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- ZhiMin Shao, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403529
- Sponsor's protocol ID
- ZY(2018-2020)-CCCX-2005-04
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04403529
- Acronym / sponsor ID
- ZY(2018-2020)-CCCX-2005-04
- Conditions
- Triple Negative Breast Cancer
- Keywords
- adjuvant therapy, traditional chinese medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine | Experimental | Drug: Traditional Chinese Medicine Formulation60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation) |
| Placebo | Placebo comparator | Drug: Placebo Formulation60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine FormulationAlso: "prescription for breast cancer" Traditional Chinese Medicine formulationThe "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. | Drug | Traditional Chinese Medicine |
| Placebo FormulationAlso: Placebo granules contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% fillerPlacebo 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. | Drug | Placebo |
Primary outcome
Disease free survival
Time frame: 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.
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.
7 secondary outcomes
Local recurrence rate
Time frame: 1,2,3 years
Distant metastasis rate
Time frame: 1,2,3 years
Overall survival
Time frame: 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.
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 Karnofsky performance score (KPS)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
Related trials for Triple Negative Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZhiMin Shao, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traditional Chinese Medicine Formulation in people with Triple Negative Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZhiMin Shao, MD, PhD (+86-21-64175590 ext. 8808, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.