Clinical trial NCT01433562: Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients
Official title: Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant therapy
Stage II/III
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Clinical response as measured by RECIST
timeFrame: 63 - 84 days
Secondary outcomes:
measure: Rate of clinical response
timeFrame: 21 - 84 days
measure: Rate of pathological complete response (after surgery)
timeFrame: 7 - 14 days after the last cycle
measure: Rate of potential breast-conserving procedure
timeFrame: 63-84 days
measure: The change level of relevant biomarkers
timeFrame: 21 - 84 days
measure: Haematology
timeFrame: 21-84 days
measure: Liver Function
timeFrame: 21-84 days
measure: Renal Function
timeFrame: 21-84 days
measure: Cardiac function
timeFrame: 63-84 days
measure: Adverse Events
timeFrame: 1 - 84 days
measure: The improvement of quality of life
timeFrame: 21 - 84 days
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital
state: East Java
Study officials:
affiliation: Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital
name: Heru Purwanto, MD, SpB(K)Onk, MSc.
role: PRINCIPAL_INVESTIGATOR
References: