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

NCT01433562 | Completed Phase 2 DMC

• 1 other identifier: DLBS1425-0310
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; neoadjuvant therapy; Stage II/III

Outcome Measures

Primary Outcomes (1)

• Clinical response as measured by RECIST

  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.

  63 - 84 days

Secondary Outcomes (10)

• Rate of clinical response

  21 - 84 days

• Rate of pathological complete response (after surgery)

  7 - 14 days after the last cycle

• Rate of potential breast-conserving procedure

  63-84 days

• The change level of relevant biomarkers

  21 - 84 days

• Haematology

  21-84 days

Study Arms (2)

DLBS1425

EXPERIMENTAL

Drug: DLBS1425

Placebo

PLACEBO COMPARATOR

Drug: Placebo DLBS1425

Interventions

DLBS1425 DRUG

DLBS1425 capsule 150 mg thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.

DLBS1425

Placebo DLBS1425 DRUG

Placebo DLBS1425 capsule thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

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

Surabaya, East Java, 60286, Indonesia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DLBS 1425

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Heru Purwanto, MD, SpB(K)Onk, MSc.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 14, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

ID (1)