NCT01433562

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

Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	DLBS1425	DLBS1425 capsule 150 mg thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.
DRUG	Placebo DLBS1425	Placebo DLBS1425 capsule thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-09-14
• Last updated: 2013-05-13

Locations

1 site across 1 country: Indonesia