Breast CancerPhase 2/3NCT01433562
Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients
A Phase 2/3 study testing DLBS1425 in people with Breast Cancer, run by Dexa Medica Group at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DLBS1425
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2011to Nov 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital
Surabaya, East Java, 60286
About this study
Official title: Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- DLBS1425, Placebo DLBS1425
- Keywords
- breast cancer, neoadjuvant therapy, Stage II/III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1425Drug
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.
Placebo DLBS1425Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| DLBS1425 | Experimental | Not described Receives: Drug: DLBS1425 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo DLBS1425 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 63 - 84 days
Secondary outcomes (10)
Rate of clinical response
Rate of clinical response categorized as complete response, partial response, stable, and progressive disease, which will be evaluated clinically at the end of every cycle
Measured: 21 - 84 days
Rate of pathological complete response (after surgery)
Pathological complete response based on histological examination will be assessed after surgery. The surgery itself will be performed within 7 - 14 days after the last cycle.
Measured: 7 - 14 days after the last cycle
Rate of potential breast-conserving procedure
Rate of potential breast-conserving procedure as assessed by mammography, will be evaluated at the end of study.
Measured: 63-84 days
The change level of relevant biomarkers
Relevant biomarkers related to breast cancer (CEA, CA-15.3, and serum LDH)will be measured at baseline and at the end of every cycle.
Measured: 21 - 84 days
Haematology
Haematology parameters (Haemoglobin level, Haematocrit, red blood cell count, white blood cell count as well as its differentials, and platelet count) will be evaluated at baseline and the end of every cycle.
Measured: 21-84 days
Liver Function
Liver function parameters (alkaline phosphatase, ALT, AST, bilirubin levels)will be measured at baseline, and the end of every cycle.
Measured: 21-84 days
Renal Function
Renal Function (serum creatinine and Blood urea nitrogen levels) will be measured at baseline and the end of every cycle.
Measured: 21-84 days
Cardiac function
Cardiac function will be assessed by ECHOcardiography at baseline and the end of study.
Measured: 63-84 days
Adverse Events
Adverse events as well as number of subjects experienced the events will be observed and evaluated during the study period (from the first dose of study medication taken (Day 1) till the end of study treatment (Day 63 - Day 84).
Measured: 1 - 84 days
The improvement of quality of life
The improvement of quality of life of the subjects as measured at baseline and at the end of each treatment cycle, using Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (FACIT.org)
Measured: 21 - 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heru Purwanto, MD, SpB(K)Onk, MSc., Principal investigator, Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433562
- Sponsor's protocol ID
- DLBS1425-0310
- Status last verified
- May 2013
- First submitted
- 9 Sep 2011
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of DLBS1425 With Anthracyclin-based Regimen as a Neoadjuvant Therapy in Subjects With Stage II or III Breast Cancer
- ClinicalTrials.gov ID
- NCT01433562
- Acronym / sponsor ID
- DLBS1425-0310
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant therapy, Stage II/III
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLBS1425 | Experimental | Drug: DLBS1425 |
| Placebo | Placebo comparator | Drug: Placebo DLBS1425 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLBS1425DLBS1425 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. | Drug | DLBS1425 |
| Placebo DLBS1425Placebo 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. | Drug | Placebo |
Primary outcome
Clinical response as measured by RECIST
Time frame: 63 - 84 days
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.
10 secondary outcomes
Rate of clinical response
Time frame: 21 - 84 days
Rate of pathological complete response (after surgery)
Time frame: 7 - 14 days after the last cycle
Rate of potential breast-conserving procedure
Time frame: 63-84 days
The change level of relevant biomarkers
Time frame: 21 - 84 days
Haematology
Time frame: 21-84 days
Liver Function
Time frame: 21-84 days
Renal Function
Time frame: 21-84 days
Cardiac function
Time frame: 63-84 days
Adverse Events
Time frame: 1 - 84 days
The improvement of quality of life
Time frame: 21 - 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heru Purwanto, MD, SpB(K)Onk, MSc. principal investigator
Surgery-Oncology Division, Department of Surgery, Faculty of Medicine, University of Airlangga / Dr. Soetomo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DLBS1425 in people with Breast Cancer, run by Dexa Medica Group at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response as measured by RECIST (time frame: 63 - 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.