Disease	Breast cancer
Stage of Disease/Treatment	Metastatic/advanced
Prior Therapy	No designated number of regimens
Type of Study	Phase II, single arm
Primary Endpoint	Progression‐free survival
Secondary Endpoints	Overall response rate, clinical benefit rate
Additional Details of Endpoints or Study Design
All enrolled patients who received at least two cycles of moxifloxacin in combination with their ongoing treatment (intention‐to‐treat population) were included for efficacy and safety analysis. Tumor assessments were conducted with CT scans at baseline, after every 2–3 cycles of study medication until a 6‐month visit, and every 2 months thereafter until 12 months. Tumor response to treatment was determined according to RECIST (version 1.1). All CT scans of enrolled patients were evaluated independently by two experienced radiologists. Safety evaluation and survival follow‐up, including vital signs, physical examinations, and laboratory tests, were performed every month until the 6‐month visit, then every 2 months until the 12‐month visit. Continuous variables were described using mean and standard deviation or median and interquartile range when appropriate. Categorical variables were described using frequency and percentage. The primary endpoint of the present study was PFS, defined as the duration from the date of administration of moxifloxacin to the date of progressive disease (PD), death from any cause, or the last follow‐up, whichever came first. Secondary endpoints were ORR and CBR. ORR was defined as the proportion of patients with a complete response (CR) and PR. CBR was defined as the proportion of patients with CR, PR, and SD for at least 6 months. PFS was calculated using the Kaplan‐Meier method. The statistical analysis was performed using SPSS version 22.0 software (SPSS A, Inc., Chicago, IL).
Investigator's Analysis	Active and should be pursued further