Recurrent Breast CancerPhase 4NCT00912639
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
A Phase 4 study testing Paclitaxel loaded Polymeric micelle in people with Recurrent Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Breast Cancer
- What is being tested?
- Paclitaxel loaded Polymeric micelle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to May 2011
- Phase
- Phase 4
- 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
- Women aged >=18 years
- WHO (ECOG) performance status 0-2
- Estimated life expectancy of >=3 months
- Have given written informed consent and are available for prolonged follow-up
Who cannot join
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
- uncontrolled infection, medically uncontrollable heart disease
- other serious medical illness or prior malignancies
- Pregnant or lactating women were excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
Seoul
About this study
Official title: A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
Read the detailed description
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.
- Conditions
- Recurrent Breast Cancer
- Being tested
- Paclitaxel loaded Polymeric micelle
- Keywords
- recurrent breast cancer, Genexol-PM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel loaded Polymeric micelleDrug
Also called Genexol-PM®
Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.
| Study group | Role | What they receive |
|---|---|---|
| Genexol-PM | Experimental | All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion)
1. Spiral CT : lesion ≥ 10mm (unidimension)
2. X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension) Receives: Drug: Paclitaxel loaded Polymeric micelle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
Measured: 1 year
Secondary outcomes (3)
Toxicity
Measured: 1 year
Progression Free Survival
Measured: 1 year
Tumor control rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Breast Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Byung-Joo Song, MD.PhD., Principal investigator, The Catholoic university of Korea, St. Mary's hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912639
- Sponsor's protocol ID
- KBCSG004
- Status last verified
- Jun 2009
- First submitted
- 31 May 2009
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT00912639
- Acronym / sponsor ID
- KBCSG004
- Conditions
- Recurrent Breast Cancer
- Keywords
- recurrent breast cancer, Genexol-PM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Korean Breast Cancer Study GroupUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 3 Jun 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 evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
Detailed description
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genexol-PM | Experimental | Drug: Paclitaxel loaded Polymeric micelleAll the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion) 1. Spiral CT : lesion ≥ 10mm (unidimension) 2. X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged >=18 years
- WHO (ECOG) performance status 0-2
- Estimated life expectancy of >=3 months
- Have given written informed consent and are available for prolonged follow-up
Key exclusion criteria (8 listed)
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
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 |
|---|---|---|
| Paclitaxel loaded Polymeric micelleAlso: Genexol-PM®Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended. | Drug | Genexol-PM |
Primary outcome
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
Time frame: 1 year
3 secondary outcomes
Toxicity
Time frame: 1 year
Progression Free Survival
Time frame: 1 year
Tumor control rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
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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.
Byung-Joo Song, MD.PhD. principal investigator
The Catholoic university of Korea, St. Mary's hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paclitaxel loaded Polymeric micelle in people with Recurrent Breast Cancer, run by Korean Breast Cancer Study Group 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Jun 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline (time frame: 1 year). 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 16 Jun 2009.