NCT01433562 - Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions

Breast Cancer

Interventions

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.

Trial Locations (1)

60286

Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital, Surabaya