Progression-Free-SurvivalNCT03332368
Clinical Study on Triple Negative Breast Cancer With Chinese Medicine
An observational study of Progression-Free-Survival and Recurrence, run by Sheng Liu at 5 sites in China.
Trial summary
Breast cancer is one of the most serious threat to women's health of malignant tumors, also the most common causes of cancer death in women.Triple-negative breast cancer (TNBC) refers to the immunohistochemical detection of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Progression-Free-Survival, Recurrence, Overall Survival
- What is being tested?
- Traditional Chinese medicine
- How many people
- 620 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2017to 1 Jan 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Reference to the 《Chinese Medical Association prepared the "clinical treatment guidelines • tumor volume"》， all postoperative cases have been clearly diagnosed as triple negative breast cancer by pathological cells and immunohistochemistry.
Participants' inclusion criteria are as follows:
- The primary breast cancer after surgical treatment, the pathological diagnosis of breast epithelial tumors (breast cancer), ER, PR and Her-2 immunohistochemical results were negative;
- no recurrence of metastasis;
- card score ≥ 60 points;
- Female patients aged 18-75 years (including 18,75 years);
- there is no serious organic or functional disorders, no drugs and food allergy;
- willing to receive treatment, observation and inspection.
Participants' exclusion criteria are as follow:
- does not meet the inclusion criteria;
- patients expected to survive <6 months;
- combined with cardiovascular and cerebrovascular, liver, kidney, hematopoietic system of serious primary disease and mental illness;
- breastfeeding, pregnancy or women preparing for pregnancy;
- allergies and allergies to a variety of drugs;
- are participating in other drug subjects.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 220000
Liu Guangyu, Master
- Recruiting
Longhua Hosptial
Shanghai, Shanghai Municipality, 220000
LiuSheng Sheng, Master, +861891773005, lshtcm@163.com
- Recruiting
ShuGuang Hospital
Shanghai, Shanghai Municipality, 220000
Wan Hua, Master, +86 021-20256666
- Recruiting
Yueyang Hospital
Shanghai, Shanghai Municipality, 220000
Xue Xiaohong, Master, +86 021-65161782
- Recruiting
Zhejiang Traditional Chinese Medicine Hospital
Zhejiang, Zhejiang
Gao Xiufei, Master, +86 0571-87068001
About this study
Official title: Clinical Study on Prevention and Treatment of Recurrent and Metastasis of Triple Negative Breast Cancer(TNBC) With Traditional Chinese Medicine(TCM)
Breast cancer is one of the most serious threat to women's health of malignant tumors, also the most common causes of cancer death in women.Triple-negative breast cancer (TNBC) refers to the immunohistochemical detection of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (Her-2) are negative.Compared with other types of breast cancer, TNBC has a high degree of invasion,local recurrence and metastasis. Also,TNBC can not use endocrine therapy and lack of molecular targeting for Her-2 target therapy.Meanwhile other biological agents are too expensive,so the current clinical therapy only can use in China is chemotherapy,the average survival time is about 2 years.
Fortunately,due to the impact of traditional Chinese medicine(TCM) in China, the majority of breast cancer patients have received varying degrees of TCM treatment, and because of TNBC patients can not be more mature endocrine therapy and anti-molecular targeted therapy Benefits, Chinese medicine play an important role in TNBC patients.TCM regulate immune function, inhibit tumor growth, Anti-recurrence and metastasis, to extend the survival of patients with tumor, and relative to chemotherapy drugs and molecular targeted drugs,improve the quality of life.In addition ,comparing with the biological agents,Chinese medicine prices are relatively low,and can be worth using widely.
Read more
With the development of evidence-based medicine, and gradually recognize the importance of comprehensive treatment of breast cancer, Cancer Treatment Model has been proposed,.That is, to take Chinese medicine, surgery, radiotherapy and chemotherapy, endocrine therapy and biological immunization and other standardized, individualized comprehensive treatment. The introduction of evidence-based medicine into the field of research, will be beneficial to the objective evaluation of TCM syndrome differentiation in the treatment of refractory breast cancer in the characteristics and advantages in order to promote the use of.
This study based on TCM syndrome differentiation and treatment, and adopts multi-center, randomized, double-blind and controlled research methods to evaluate whether the intervention of traditional Chinese medicine can improve the TNBC patients with disease-free survival (DFS), overall survival(OS),and the best time to intervene in traditional Chinese medicine; also the establishment of the exact effect, obvious advantages and evidence, can be promoted in line with clinical practice of the program, the formation of refractory breast Cancer and Western medicine combined with clinical path, and relying on the national clinical research base of Chinese medicine information platform, the construction of clinical information management cloud platform, the formation of active medical service process, the establishment of refractory breast cancer combined with clinical prevention and treatment center, improve the life quality level of TNBC patients.
The study contains 5 locations,including Longhua Hospital, Shuguang Hospital,Yueyang Hospital,Zhejiang Traditional Chinese Medicine Hospital and Fudan University Cancer Hospital.Considering of the results of the study at MD Anderson Cancer Center in foreign countries showed that the 3-year survival rate of TNBC patients was significantly shorter than that of non-TNBC patients (74% vs.89%, P <0.01) To be at least 10% survival rate.At the same time, considering the case lost rate of 20%, calculated by PASS software, the number of samples for each group of 310 cases, a total of 620 cases of cohort study. According to whether to take traditional Chinese medicine,all the participants are divided into exposure group and non-exposure group, the number of observations per group is 310.
Before the research, all participants needs to fill in the informed consent form, investigators introduce the clinical research related matters to them and record the basic situation. The Chinese medicine exposure group take Chinese medicine(San Yin Decoction ) besides of original Western medicine , non-exposed group only received Western medicine treatment, a total of two years.All results are recorded in the CRF table,and use SPSS18.0, Stata10.0 and other statistical software for data to analysis.
- Conditions
- Progression-Free-Survival, Recurrence, Overall Survival
- Being tested
- Traditional Chinese medicine
- Keywords
- Triple-negative breast cancer, Traditional Chinese Medicine
- Medical subject headings
- Recurrence, 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 medicineOther
Chinese medicine has a long history of prevention and treatment of breast cancer, the effect is obvious. Chinese medicine its mechanism of action is from the whole, adjust the body yin and yang, blood, viscera function balance, emphasizing the combination of governance and external treatment of the combination of thinking, according to different clinical syndromes, using syndrome differentiation.
| Study group | Role | What they receive |
|---|---|---|
| TCM exposure group | TCM exposure group were treated with traditional Chinese medicine while the other do not treated with that Receives: Other: Traditional Chinese medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival, PFS
Progression-Free-Survival (PFS): Calculates the time from patient treatment to disease recurrence or death due to disease progression.Unit: month
Measured: 2 years
Overall Survival，OS
Overall Survival (OS) refers to the time from the beginning of treatment to death due to any cause.Unit: month
Measured: 2 years
Secondary outcomes (4)
TCM Symptom Scale
CM Symptom: basing on the "Chinese Medicine New Drug Clinical Research Guidelines (Trial)" (China Medical Science and Technology Press, 2002) ,the investigators evaluate the TCM Symptom every 3 months,and using scoring method to evaluate efficacy.All results are recorded in the CRF table.
Significant improvement: the integral value after treatment than the integral value before treatment decreased by ≥ 70% Partial improvement: the integral value after treatment than the integral value before treatment decreased by ≥ 30%; No improvement: before and after treatment without change or after treatment integral value than the integral value before treatment decreased by <30%
Measured: 2 years
Karnofsky Performance Status（KPS）
The Karnofsky Performance Status (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death. Practitioners occasionally assign performance scores in between standard intervals of 10. The investigators evaluate the KPS score every 3 months,and using scoring method to evaluate efficacy.All results are recorded in the CRF table.
Improved: KPS score increased> 10 points and maintained for more than 4 weeks; Stable: KPS score no significant change; Worsening: KPS score reduced by <10 points
Measured: 2 years
ECOG score
he Eastern Cooperative Oncology Group (ECOG) score (published by Oken et al. in 1982), runs from 0 to 5, with 0 denoting perfect health and 5 death,The investigators evaluate the KPS score every 3 months,and using scoring method to evaluate efficacy.All results are recorded in the CRF table.
Measured: 2 years
European Organization for Research and Treatment of Cancer (EORTC) Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
his questionnaire is focus on participants' physical condition and the quality of life .The investigators evaluate the score every 3 months,and using scoring method to evaluate efficacy.All results are recorded in the CRF table.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progression-Free-SurvivalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 620 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sheng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng Liu, Longhua Hospital
- Investigators
- Liu Sheng, Master, Study chair, Longhua HospitalQin Yuenong, Master, Study director, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332368
- Sponsor's protocol ID
- LonghuaH(TNBC)
- Other IDs
- Special Research on TCM
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Qin Y, Sun C, Hao W, Zhang S, Wang Y, Chen J, Chen L, Ruan Y, Liu S. Clinical study on postoperative triple-negative breast cancer with Chinese medicine: Study protocol for an observational cohort trial. Medicine (Baltimore). 2018 Jun;97(25):e11061. doi: 10.1097/MD.0000000000011061.
PubMed 29923998
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Prevention and Treatment of Recurrent and Metastasis of Triple Negative Breast Cancer(TNBC) With Traditional Chinese Medicine(TCM)
- ClinicalTrials.gov ID
- NCT03332368
- Acronym / sponsor ID
- LonghuaH(TNBC)
- Conditions
- Progression-Free-Survival, Recurrence, Overall Survival
- Keywords
- Triple-negative breast cancer, Traditional Chinese Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Sheng LiuUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 6 Nov 2017 (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.
Breast cancer is one of the most serious threat to women's health of malignant tumors, also the most common causes of cancer death in women.Triple-negative breast cancer (TNBC) refers to the immunohistochemical detection of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (Her-2) are negative.Compared with other types of breast cancer, TNBC has a high degree of invasion,local recurrence and metastasis. Also,TNBC can not use endocrine therapy and lack of molecular targeting for Her-2 target therapy.Meanwhile other biological agents are too expensive,so the current clinical therapy only can use in China is chemotherapy,the average survival time is about 2 years.
Fortunately,due to the impact of traditional Chinese medicine(TCM) in China, the majority of breast cancer patients have received varying degrees of TCM treatment, and because of TNBC patients can not be more mature endocrine therapy and anti-molecular targeted therapy Benefits, Chinese medicine play an important role in TNBC patients.TCM regulate immune function, inhibit tumor growth, Anti-recurrence and metastasis, to extend the survival of patients with tumor, and relative to chemotherapy drugs and molecular targeted drugs,improve the quality of life.In addition ,comparing with the biological agents,Chinese medicine prices are relatively low,and can be worth using widely.
With the development of evidence-based medicine, and gradually recognize the importance of comprehensive treatment of breast cancer, Cancer Treatment Model has been proposed,.That is, to take Chinese medicine, surgery, radiotherapy and chemotherapy, endocrine therapy and biological immunization and other standardized, individualized comprehensive treatment. The introduction of evidence-based medicine into the field of research, will be beneficial to the objective evaluation of TCM syndrome differentiation in the treatment of refractory breast cancer in the characteristics and advantages in order to promote the use of.
This study based on TCM syndrome differentiation and treatment, and adopts multi-center, randomized, double-blind and controlled research methods to evaluate whether the intervention of traditional Chinese medicine can improve the TNBC patients with disease-free survival (DFS), overall survival(OS),and the best time to intervene in traditional Chinese medicine; also the establishment of the exact effect, obvious advantages and evidence, can be promoted in line with clinical practice of the program, the formation of refractory breast Cancer and Western medicine combined with clinical path, and relying on the national clinical research base of Chinese medicine information platform, the construction of clinical information management cloud platform, the formation of active medical service process, the establishment of refractory breast cancer combined with clinical prevention and treatment center, improve the life quality level of TNBC patients.
The study contains 5 locations,including Longhua Hospital, Shuguang Hospital,Yueyang Hospital,Zhejiang Traditional Chinese Medicine Hospital and Fudan University Cancer Hospital.Considering of the results of the study at MD Anderson Cancer Center in foreign countries showed that the 3-year survival rate of TNBC patients was significantly shorter than that of non-TNBC patients (74% vs.89%, P <0.01) To be at least 10% survival rate.At the same time, considering the case lost rate of 20%, calculated by PASS software, the number of samples for each group of 310 cases, a total of 620 cases of cohort study. According to whether to take traditional Chinese medicine,all the participants are divided into exposure group and non-exposure group, the number of observations per group is 310.
Before the research, all participants needs to fill in the informed consent form, investigators introduce the clinical research related matters to them and record the basic situation. The Chinese medicine exposure group take Chinese medicine(San Yin Decoction ) besides of original Western medicine , non-exposed group only received Western medicine treatment, a total of two years.All results are recorded in the CRF table,and use SPSS18.0, Stata10.0 and other statistical software for data to analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCM exposure group | – | Other: Traditional Chinese medicineTCM exposure group were treated with traditional Chinese medicine while the other do not treated with that |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Reference to the 《Chinese Medical Association prepared the "clinical treatment guidelines • tumor volume"》， all postoperative cases have been clearly diagnosed as triple negative breast cancer by pathological cells and immunohistochemistry.
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 medicineChinese medicine has a long history of prevention and treatment of breast cancer, the effect is obvious. Chinese medicine its mechanism of action is from the whole, adjust the body yin and yang, blood, viscera function balance, emphasizing the combination of governance and external treatment of the combination of thinking, according to different clinical syndromes, using syndrome differentiation. | Other | TCM exposure group |
Primary outcome
Progression-Free-Survival, PFS
Time frame: 2 years
Progression-Free-Survival (PFS): Calculates the time from patient treatment to disease recurrence or death due to disease progression.Unit: month
Overall Survival，OS
Time frame: 2 years
Overall Survival (OS) refers to the time from the beginning of treatment to death due to any cause.Unit: month
4 secondary outcomes
TCM Symptom Scale
Time frame: 2 years
Karnofsky Performance Status（KPS）
Time frame: 2 years
ECOG score
Time frame: 2 years
European Organization for Research and Treatment of Cancer (EORTC) Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 29923998Chen J, Qin Y, Sun C, Hao W, Zhang S, Wang Y, Chen J, Chen L, Ruan Y, Liu S. Clinical study on postoperative triple-negative breast cancer with Chinese medicine: Study protocol for an observational cohort trial. Medicine (Baltimore). 2018 Jun;97(25):e11061. doi: 10.1097/MD.0000000000011061.
- Individual participant dataSharing planned: No
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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.
Liu Sheng, Master study chair
Longhua Hospital
Qin Yuenong, Master study director
Longhua Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progression-Free-Survival and Recurrence, run by Sheng Liu at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Liu Sheng, Master (+8618917763005, lshtcm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival, PFS (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332368, which also lists 1 linked publication.
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 7 Nov 2017.