Know Cancer

forgot password

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

Phase 2/Phase 3
18 Years
65 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Clinical response as measured by RECIST

Outcome Description:

Best overall response rate defined as proportion of subjects with either complete or partial response, according to the RECIST criteria at the end of study.

Outcome Time Frame:

63 - 84 days

Safety Issue:


Principal Investigator

Heru Purwanto, MD, SpB(K)Onk, MSc.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Indonesia: National Agency of Drug and Food Control

Study ID:




Start Date:

August 2011

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • neoadjuvant therapy
  • Stage II/III
  • Breast Neoplasms