Breast Cancer Clinical Trial
Official title:
Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer
This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the
efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a
neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast
cancer.
The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The
neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each
cycle will be 21-28 days.
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
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