Clinical study on postoperative triple-negative breast cancer with Chinese medicine: Study protocol for an observational cohort trial

Jiajing Chen, Yuenong Qin, Chenping Sun, Wei Hao, Shuai Zhang, Yi Wang, Juan Chen, Lixin Chen, Yiying Ruan, Sheng Liu, Jiajing Chen, Yuenong Qin, Chenping Sun, Wei Hao, Shuai Zhang, Yi Wang, Juan Chen, Lixin Chen, Yiying Ruan, Sheng Liu

Abstract

Background: Breast cancer (BC) poses a tremendous threat to the health of women worldwide, especially triple-negative breast cancers (TNBCs). Currently, the curative effect of traditional Chinese medicine (TCM) has been recognized in more and more people worldwide; however, the specific effect has not been systematically evaluated. The purpose of this cohort study is to evaluate the clinical effects of TCM syndrome differentiation on recurrence and metastasis rate, survival rate, and the quality of life in patients with TNBC.

Methods: This study is a multicenter observational cohort trial taking 2 years. A total of 620 patients will be allocated at a ratio of 1:1 to receive TCM or not. The primary outcomes are progression-free survival (PFS) and overall survival (OS), which are calculated at the end of the trial. Secondary outcomes include TCM symptoms, Karnofsky Performance Status (KPS), ECOG score, European Organization for Research and Treatment of Cancer (EORTC) Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23), as well as clinical indicators including tumor markers, immune function evaluation, chest computed tomography/magnetic resonance imaging, and abdominal B-ultrasound. Assessments will be performed at baseline and 3, 6, 9, 12, 16, and 20 weeks after observation.

Discussion: This will be the first clinical trial to evaluate the PFS and OS in TNBC patients receiving TCM, which may be used to assess the feasibility of a larger-scale clinical trial in the future, and formulate a standardized TCM treatment plan.

Study registration: ClinicalTrials.gov (NCT03332368).

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Flow chart of the study.

References

    1. Youlden DR, Cramb SM, Yip CH, et al. Incidence and mortality of female breast cancer in the AsiaPacific region. Cancer Biol Med 2014;11:101–15.
    1. Yu T, Di G. Role of tumor microenvironment in triple-negative breast cancer and its prognostic significance. Chin J Cancer Res 2017;29:237–52.
    1. Wahba HA, El-Hadaad HA. Current approaches in treatment of triple-negative breast cancer. Cancer Biol Med 2015;12:106–16.
    1. Yadav BS, Sharma SC, Chanana P, et al. Systemic treatment strategies for triple-negative breast cancer. World J Clin Oncol 2014;5:125–33.
    1. Xu JP, Xu SG, Zhang Y, et al. Clinicopathological features and prognostic factors of triple-negative breast cancer. J Shanghai Jiaotong Univ 2011;31:637–41.
    1. Liu HF, Zhang J. Clinicopathological features and prognostic factors of triple negative breast cancer. J Hebei Med 2012;18:380–2.
    1. Liu HJ, Wu YH. Research progress on treating triple negative breast cancer with traditional Chinese medicine and chemotherapy. J Hunan Trad Chin Med 2016;32:189–92.
    1. Qu WC. Chinese herbal compound on breast cancer patients with 5-year disease-free survival rate and overall survival rate. China Medical Herald 2012;9:120–2.
    1. Iwanowycz S, Wang J, Hodge J, et al. Emodin inhibits breast cancer growth by blocking the tumor-promoting feedforward loop between cancer cells and macrophages. Mol Cancer Ther 2016;15:1931–42.
    1. Zhang J, Yu K, Han X, et al. Paeoniflorin influences breast cancer cell proliferation and invasion via inhibition of the Notch-1 signaling pathway. Mol Med Rep 2018;17:1321–5.
    1. Wang J, Yang X, Han H, et al. Inhibition of growth and metastasis of triple-negative breast cancer targeted by traditional Chinese medicine Tubeimu in orthotopic mice models. Chin J Cancer Res 2018;30:112–21.
    1. Zhang F, Kong LL, Zhang YY, et al. Evaluation of impact on health-related quality of life and cost effectiveness of traditional Chinese medicine: a systematic review of randomized clinical trials. J Altern Complement Med 2012;18:1108–20.
    1. Liu S, Zhao J, Liu J, et al. Breast cancer recurrence and metastasis rate of 5 years after breast cancer surgery. J Integr Med 2008;6:1000–4.
    1. He XR, Han SY, Li PP. Recent highlights of experimental research for inhibiting tumor growth by using Chinese medicine. Chin J Integr Med 2015;21:727–32.
    1. New York, NY, Chow SC, Wang H, Shao J. Sample Size Calculations in Clinical Research (2nd Edition). 2003;Chapman & Hall/CRC,
    1. Jehn CF, Flath B, Strux A, et al. Influence of age, performance status, cancer activity, and IL-6 on anxiety and depression in patients with metastatic breast cancer. Breast Cancer Res Treat 2012;136:789–94.
    1. Anker CJ, Grossmann KF, Atkins MB, et al. Avoiding severe toxicity from combined BRAF inhibitor and radiation treatment: consensus guidelines from the Eastern Cooperative Oncology Group (ECOG). Int J Radiat Oncol Biol Phys 2016;95:632–46.
    1. Cheng JX, Liu BL, Zhang X, et al. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol 2011;11:56.
    1. Ovcaricek T, Frkovic SG, Matos E, et al. Triple negative breast cancer – prognostic factors and survival. Radiol Oncol 2011;45:46–52.
    1. Steponaviciene L, Lachej-Mikeroviene N, Smailyte G, et al. Triple negative breast cancer: adjuvant chemotherapy effect on survival. Adv Med Sci 2011;56:285–90.
    1. Tsunoda-Shimizu H, Nakamura S. Diagnostic assessment of nonpalpable breast cancer: the difference in diagnostic approach for the clinical treatment of breast cancer between the Japanese Guidelines and the National Comprehensive Cancer Network (USA)Guidelines. Breast Cancer 2005;12:250–7.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner