Clinical trial NCT03332368: Clinical Study on Triple Negative Breast Cancer With Chinese Medicine
Official title: Clinical Study on Prevention and Treatment of Recurrent and Metastasis of Triple Negative Breast Cancer(TNBC) With Traditional Chinese Medicine(TCM)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Progression-Free-Survival
Recurrence
Overall Survival
Keywords: Triple-negative breast cancer
Traditional Chinese Medicine
Lead sponsor: Longhua Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 620
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 (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.


Eligibility criteria: Participants' inclusion criteria are as follows:

1. 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;
2. no recurrence of metastasis;
3. card score ≥ 60 points;
4. Female patients aged 18-75 years (including 18,75 years);
5. there is no serious organic or functional disorders, no drugs and food allergy;
6. willing to receive treatment, observation and inspection.

Participants' exclusion criteria are as follow:

1. does not meet the inclusion criteria;
2. patients expected to survive \<6 months;
3. combined with cardiovascular and cerebrovascular, liver, kidney, hematopoietic system of serious primary disease and mental illness;
4. breastfeeding, pregnancy or women preparing for pregnancy;
5. allergies and allergies to a variety of drugs;
6. are participating in other drug subjects.

Primary outcomes:
measure: Progression-Free-Survival, PFS
timeFrame: 2 years
measure: Overall Survival，OS
timeFrame: 2 years
Secondary outcomes:
measure: TCM Symptom Scale
timeFrame: 2 years
measure: Karnofsky Performance Status（KPS）
timeFrame: 2 years
measure: ECOG score
timeFrame: 2 years
measure: European Organization for Research and Treatment of Cancer (EORTC) Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
timeFrame: 2 years
Other outcomes:
measure: Clinical indicators
timeFrame: 2 years
measure: Adverse Event
timeFrame: 2 years
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hosptial
state: Shanghai
city: Shanghai
country: China
facility: ShuGuang Hospital
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Hospital
state: Shanghai
city: Zhejiang
country: China
facility: Zhejiang Traditional Chinese Medicine Hospital
state: Zhejiang
Study officials:
affiliation: Longhua Hospital
name: Liu Sheng, Master
role: STUDY_CHAIR
affiliation: Longhua Hospital
name: Qin Yuenong, Master
role: STUDY_DIRECTOR
References:
citation: 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.