Breast CancerPhase 4NCT02142790
Weekly and Every 3 Week Administration of Paclitaxel Liposome Injection in Metastatic Breast Cancer
A Phase 4 study testing paclitaxel liposome injection in people with Breast Cancer, run by Nanjing Luye Sike Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- paclitaxel liposome injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Jun 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or Male >18 years of age and < 70years of age, If female of childbearing potential, pregnancy test is negative before first dose of study drug and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
- Stage IV disease
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Suitable for the treatment with paclitaxel as single agent regimen (first line or prior first line chemotherapy including adriamycin is allowed, If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen and if Her2+ patient, Herceptin therapy will be allowed.
- Patient has the following values at Baseline: Absolute neutrophil count ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; hemoglobin ≥ 10 g/dL. Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ 1.5ULN; creatinine ≤ 1.5 mg/dL.
- Informed consent has been obtained.
Who cannot join
- Parenchymal brain metastases.
- History of other malignancy within the last 3 years
- New York Heart Association (NYHA) Grade 2 or greater congestive heart failure,history of myocardial infarction or unstable angina or new occured angina within 6 months prior to study enrollment.
- Concurrent other anticancer therapy.
- History of serious organic disorders (including active infection or Cardiovascular disease), serious hepatic disease, serious blood coagulation diseases, cachexia
- Sensory neuropathy of > Grade 1 at baseline.
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- Patients with prior hypersensitivity to paclitaxel
- Pregnant or nursing women
- enrolled in a different clinical study
- No psychiatric illness and other situations that would limit compliance of study
Trial locations and contacts
1 site in 1 country.
Quchang Ouyang, MD contact
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Quchang Ouyang, MD, oyqc1969@126.com
About this study
This is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.
- Conditions
- Breast Cancer
- Being tested
- paclitaxel liposome injection
- 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 liposome injectionDrug
Also called LIPUSU
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel liposome injection weekly | Experimental | paclitaxel liposome injection 100mg/m2 administered by intravenous on day1 and day8 of a 21-day cycle for at least 4cycles or till progression or intolerable Receives: Drug: paclitaxel liposome injection |
| paclitaxel liposome injection every 3 weeks | Experimental | paclitaxel liposome injection 175mg/m2 administered by intravenous on day1 of a 21-day cycle for at least 4cycles or till progression or intolerable Receives: Drug: paclitaxel liposome injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured: 24 months
Secondary outcomes (3)
Overall Response Rate
Measured: 24 months
Clinical Benefit Rate
Measured: 24 months
Adverse Events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142790
- Sponsor's protocol ID
- LY-TM-LPS-2014-02
- Status last verified
- Jul 2014
- First submitted
- 16 May 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly and Every 3 Week Administration of Paclitaxel Liposome Injection in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02142790
- Acronym / sponsor ID
- LY-TM-LPS-2014-02
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 20 May 2014 (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 open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel liposome injection weekly | Experimental | Drug: paclitaxel liposome injectionpaclitaxel liposome injection 100mg/m2 administered by intravenous on day1 and day8 of a 21-day cycle for at least 4cycles or till progression or intolerable |
| paclitaxel liposome injection every 3 weeks | Experimental | Drug: paclitaxel liposome injectionpaclitaxel liposome injection 175mg/m2 administered by intravenous on day1 of a 21-day cycle for at least 4cycles or till progression or intolerable |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female or Male >18 years of age and < 70years of age, If female of childbearing potential, pregnancy test is negative before first dose of study drug and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
- Stage IV disease
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Suitable for the treatment with paclitaxel as single agent regimen (first line or prior first line chemotherapy including adriamycin is allowed, If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen and if Her2+ patient, Herceptin therapy will be allowed.
Key exclusion criteria (10 listed)
- Parenchymal brain metastases.
- History of other malignancy within the last 3 years
- New York Heart Association (NYHA) Grade 2 or greater congestive heart failure,history of myocardial infarction or unstable angina or new occured angina within 6 months prior to study enrollment.
- Concurrent other anticancer therapy.
- History of serious organic disorders (including active infection or Cardiovascular disease), serious hepatic disease, serious blood coagulation diseases, cachexia
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 liposome injectionAlso: LIPUSU | Drug | paclitaxel liposome injection every 3 weeks, paclitaxel liposome injection weekly |
Primary outcome
Progression-free Survival (PFS)
Time frame: 24 months
3 secondary outcomes
Overall Response Rate
Time frame: 24 months
Clinical Benefit Rate
Time frame: 24 months
Adverse Events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
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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.
Quchang Ouyang, MD contact
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 liposome injection in people with Breast Cancer, run by Nanjing Luye Sike Pharmaceutical Co., Ltd. at 1 site in China.
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 7 inclusion and 10 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 22 Jul 2014. 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 China. 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?
Contact Quchang Ouyang, MD (oyqc1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 24 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 22 Jul 2014.