Status:
COMPLETED
Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients
Lead Sponsor:
Dexa Medica Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 s...
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 cyc...
Eligibility Criteria
Inclusion
- Confirmed stage II or III (operable) primary breast cancer
- Having radiologically evaluable and measurable lesion(s) of the primary tumor
- Karnofsky performance status 80 %
- Normal cardiac function: LVEF \> 50 %
- Adequate hematological function: Hb ≥ 10.0 g/dL, WBC ≥ 3,000/mm3, ANC ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3
- Adequate liver function: ALT ≤ 2.5 times upper limit of normal, total bilirubin level ≤ 1.5 times upper limit of normal
- Adequate renal function: serum creatinine ≤ 1.5 times upper limit of normal
- Able to take oral medication
Exclusion
- Pregnancy or breast feeding subjects
- History of previous breast cancer (recurrent breast cancer)
- History of other cancer within the past 5 years
- Prior systemic treatment for the current breast cancer
- Prior preoperative topical treatments for the current breast cancer
- Uncontrolled or serious CVD
- Known or suspected hypersensitivity to any of the chemotherapeutic agents used in the study
- Any other serious disease state or medical condition which judged by investigator could interfere with trial participation or trial evaluation
- Concurrent herbal (alternative) medicines or food supplements suspected to have effect on breast cancer disease within 14 days prior to screening
- Severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
- Participation in any other clinical studies within 30 days prior to screening
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01433562
Start Date
August 1 2011
End Date
November 1 2012
Last Update
May 13 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital
Surabaya, East Java, Indonesia, 60286