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Phase II Clinical Study: A Randomized, Open, and Dose Ranging Study to Evaluate the Efficacy and Safety of DLBS1425 in Subjects With Metastatic / Advanced Breast Cancer


Phase 2
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Clinical Study: A Randomized, Open, and Dose Ranging Study to Evaluate the Efficacy and Safety of DLBS1425 in Subjects With Metastatic / Advanced Breast Cancer


Inclusion Criteria:



- Subjects diagnosed with Stage IIIB or IV breast cancer who have failed with or refuse
to receive standard chemotherapies

- Subjects with the expression of ER/PR negative; or positive ER/PR expression but have
failed with or refuse to receive hormonal therapy

- Either + or - expression of HER-2/neu gene

- ECOG status = 0-2

- At least have 1 evaluable and measurable metastatic lesion as defined by RECIST
criteria

- Adequate haematological, liver, and renal function

- At least 3 weeks has elapsed since prior chemotherapy, radiotherapy,
biological/hormonal therapy

- At least 4 weeks has elapsed since surgical biopsy / major surgery

Exclusion Criteria:

- Allergic to the trial product

- Any other disease state, including infections or uncontrolled illnesses that could
interfere with trial participation or trial evaluation

- Concurrent herbal (alternative) medicine or food supplements suspected to have effect
on cancer disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best overall response rate: proportion of subjects with either complete or partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria at the end of study

Outcome Time Frame:

12 -16 weeks

Safety Issue:

No

Principal Investigator

Abdul Muthalib, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital

Authority:

Indonesia: National Agency of Drug and Food Control

Study ID:

DLBS1425-0209

NCT ID:

NCT01006785

Start Date:

August 2009

Completion Date:

March 2012

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • DLBS 1425
  • Cancer
  • Advanced/Metastatic (Stage IIIB/IV) Breast Cancer
  • Breast Neoplasms

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