Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer
The duration of treatment for each subject will be 63 - 84 days (or 3 cycles). The cycle
will be initiated at Day-1 (D1 of the 1st cycle). The subsequent cycles will start on Day-22
(D1 of the 2nd cycle) and Day-43 (D1 of the 3rd cycle). DLBS1425 capsules will be
administered orally every day (starting from D1 of each cycle) during the study period. All
subjects will be under direct supervision of a medical doctor during the study period.
Clinical and laboratory examinations to evaluate investigational drug's efficacy and safety
will be performed at baseline and at the end of every cycle over the study course; whilst
breast-CT scan will be performed at baseline and at the end of study course.
In addition, at the end of study, at the discretion of Investigator and subjects' own
willingness, subjects with good response to treatment (i.e. RECIST and pathological
evaluation are regarded as complete or partial response) may continue their breast-cancer
therapy with DLBS1425.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Clinical response as measured by RECIST
Best overall response rate defined as proportion of subjects with either complete or partial response, according to the RECIST criteria at the end of study.
63 - 84 days
Heru Purwanto, MD, SpB(K)Onk, MSc.
Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital
Indonesia: National Agency of Drug and Food Control