drugset
drugset / Trial / NCT01433562

Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients

NCT01433562 ↗

Phase 2/3 Completed 40 enrolled Dexa Medica Group
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2011-08
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS1425 Unknown 150 mg Oral
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Epirubicin Small molecule 70 mg/m2 Intravenous
Background fluorouracil Small molecule 500 mg/m2 Intravenous

Indications

breast cancer