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

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).