Breast CancerPhase 3NCT00876486
Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
A Phase 3 study testing Genexol-PM® and Genexol® in people with Breast Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Genexol-PM® and Genexol®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Nov 2013
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects should meet all of the following criteria to participate in the trial.
- Subjects who aged 18 years or older.
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
- Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
- If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
- Subjects who have measurable disease in accordance with the RECIST criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Open-label, Randomized, Parallel, Phase III Trial to Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol®(Conventional Paclitaxel With Cremorphor EL) in Subjects With Recurrent or Metastatic Breast Cancer
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Genexol-PM®, Genexol®
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genexol-PM®Drug
Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
Genexol®Drug
Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Genexol®-PM | Experimental | This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). Receives: Drug: Genexol-PM® |
| Genexol® | Active comparator | This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). Receives: Drug: Genexol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
Measured: 6 months
Secondary outcomes (2)
Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response
To evaluate the efficacy of Genexol®-PM relative to Genexol® as measured by Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response.
Measured: Event driven
Safety and toxicity
To compare the safety and toxicity of Genexol®-PM with those of Genexol®
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2013
- Study completionNov 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876486
- Sponsor's protocol ID
- GPMBC301
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2009
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Randomized, Parallel, Phase III Trial to Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol®(Conventional Paclitaxel With Cremorphor EL) in Subjects With Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00876486
- Acronym / sponsor ID
- GPMBC301
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2008 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Apr 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.
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genexol®-PM | Experimental | Drug: Genexol-PM®This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). |
| Genexol® | Active comparator | Drug: Genexol®This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects should meet all of the following criteria to participate in the trial.
- Subjects who aged 18 years or older.
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
- Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
- If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Genexol-PM®Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks | Drug | Genexol®-PM |
| Genexol®Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks | Drug | Genexol® |
Primary outcome
Objective Response Rate
Time frame: 6 months
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
2 secondary outcomes
Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response
Time frame: Event driven
Safety and toxicity
Time frame: Throughout study
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 1 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genexol-PM® and Genexol® in people with Breast Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
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 6 inclusion and 0 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 1 May 2017. 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 South Korea. 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. 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 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?
Objective Response Rate (time frame: 6 months). 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 1 May 2017.