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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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