Clinical Study on Triple Negative Breast Cancer With Chinese Medicine

NCT03332368 | Unknown

• 2 other identifiers: LonghuaH(TNBC)Special Research on TCM
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 5

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.

Conditions

Progression-Free-Survival; Recurrence; Overall Survival

Keywords

Triple-negative breast cancer; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (2)

• 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

  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

  2 years

Secondary Outcomes (4)

• TCM Symptom Scale

  2 years

• Karnofsky Performance Status（KPS）

  2 years

• ECOG score

  2 years

• European Organization for Research and Treatment of Cancer (EORTC) Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)

  2 years

Other Outcomes (2)

• Clinical indicators

  2 years

• Adverse Event

  2 years

Study Arms (1)

TCM exposure group

TCM exposure group were treated with traditional Chinese medicine while the other do not treated with that

Other: Traditional Chinese medicine

Interventions

Traditional Chinese medicine OTHER

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.

TCM exposure group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheng Liu: lead

Study Sites (5)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 220000, China

RECRUITING

Longhua Hosptial

Shanghai, Shanghai Municipality, 220000, China

RECRUITING

ShuGuang Hospital

Shanghai, Shanghai Municipality, 220000, China

RECRUITING

Yueyang Hospital

Shanghai, Shanghai Municipality, 220000, China

RECRUITING

Zhejiang Traditional Chinese Medicine Hospital

Zhejiang, Zhejiang, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29923998 DERIVED

MeSH Terms

Conditions

Recurrence; Triple Negative Breast Neoplasms

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Liu Sheng, Master

  Longhua Hospital

  STUDY CHAIR

• Qin Yuenong, Master

  Longhua Hospital

  STUDY DIRECTOR

Central Study Contacts

Liu Sheng, Master

CONTACT

+8618917763005; lshtcm@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 6, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)