Metastatic Breast CancerPhase 2NCT00976365
Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer
A Phase 2 study testing THL-P in people with Metastatic Breast Cancer, run by Taiwan THL Co.LTd. at 1 site in Taiwan.
Trial summary
The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- THL-P
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Jun 2011
- Phase
- Phase 2
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed breast cancer with clinical evidence.
- Life expectancy of at least 4 weeks.
Who cannot join
- Any Uncontrolled infection.
- Lupus erythematosus.
- Malignant tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIa Study of Metastatic Breast Cancer
The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30).
Read the detailed description
The test article is extracted from many natural herbals, in which most or their components have been shown to have anti-tumor activity. A study in 2004 showed the test article could have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations (RAU) patients and suggested that it might be a potential immunoceutical agent for treatment of RAU. Subsequent study in 2005 also suggested the test article as a potential immunoceutical agent for treatment of RAU because the result showed it could modulate the antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study in 2005 showed the test article also had a broad-range tumor killing function and provided a molecular basis underlying therapeutic activity. It was also suggested in this study will could be a potential and promising cancer therapeutic or preventive agent.
The aim of this current study is to explore the safety and efficacy of the investigational product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the patients with metastatic breast cancer refractory to conventional treatment modalities.
- Conditions
- Metastatic Breast Cancer
- Being tested
- THL-P
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THL-PDietary supplement
Also called THL-P solution
20ml/bottle, TID, 24weeks
| Study group | Role | What they receive |
|---|---|---|
| THL-P | Experimental | Solution for study only. Receives: Dietary Supplement: THL-P |
| Sugar pill | Placebo comparator | THL-p Receives: Dietary Supplement: THL-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
QOL
Measured: 6 months measure
Secondary outcomes (1)
CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine
Measured: 6 months measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan THL Co.LTd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Investigators
- King-Jen Chang, M.D.,Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976365
- Sponsor's protocol ID
- THL-P
- Other IDs
- NTUH-REC No.2008100025M
- Status last verified
- Jun 2011
- First submitted
- 6 Jul 2009
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00976365
- Acronym / sponsor ID
- THL-P
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taiwan THL Co.LTd.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Sep 2009 (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.
The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30).
Detailed description
The test article is extracted from many natural herbals, in which most or their components have been shown to have anti-tumor activity. A study in 2004 showed the test article could have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations (RAU) patients and suggested that it might be a potential immunoceutical agent for treatment of RAU. Subsequent study in 2005 also suggested the test article as a potential immunoceutical agent for treatment of RAU because the result showed it could modulate the antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study in 2005 showed the test article also had a broad-range tumor killing function and provided a molecular basis underlying therapeutic activity. It was also suggested in this study will could be a potential and promising cancer therapeutic or preventive agent.
The aim of this current study is to explore the safety and efficacy of the investigational product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the patients with metastatic breast cancer refractory to conventional treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THL-P | Experimental | Dietary Supplement: THL-PSolution for study only. |
| Sugar pill | Placebo comparator | Dietary Supplement: THL-PTHL-p |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed breast cancer with clinical evidence.
- Life expectancy of at least 4 weeks.
Key exclusion criteria (3 listed)
- Any Uncontrolled infection.
- Lupus erythematosus.
- Malignant tumor.
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 |
|---|---|---|
| THL-PAlso: THL-P solution20ml/bottle, TID, 24weeks | Dietary supplement | Sugar pill, THL-P |
Primary outcome
QOL
Time frame: 6 months measure
1 secondary outcome
CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine
Time frame: 6 months measure
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 9 Jun 2011.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
King-Jen Chang, M.D.,Ph.D. principal investigator
National Taiwan University 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 study testing THL-P in people with Metastatic Breast Cancer, run by Taiwan THL Co.LTd. at 1 site in Taiwan.
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 2 inclusion and 3 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 9 Jun 2011. 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 Taiwan. 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 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.
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?
QOL (time frame: 6 months measure). 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 9 Jun 2011.