Breast CancerNCT02142010
Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer
A study testing paclitaxel liposome injection plus cisplatin in people with Breast Cancer, run by Nanjing Luye Sike Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen. 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?
- paclitaxel liposome injection plus cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jun 2015
- Phase
- Interventional
- 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
- Women aged ≥ 18 years and < 65 years,An estimated life expectancy of at least 12 months
- ECOG 0-1
- At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer, stage II and III, no prior systemic or loco-regional treatment of breast cancer
- Biopsy specimens are available for ER, PgR and Her2 analysis
- Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
- adequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL;
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- Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
- No obvious main organs dysfunction
- patients must be accessible for treatment and follow-up and written informed consent
Who cannot join
- Patient is pregnant or breast feeding
- Inflammatory breast cancer and Metastatic breast cancer
- Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
- History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
- Has peripheral neuropathy
- Treatment with any investigational drugs within 30 days before the beginning of study treatment
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- No psychiatric illness and other situations that would limit compliance of study
- With a history of other malignant tumor
- Known severe hypersensitivity to any drugs in this study
Trial locations and contacts
1 site in 1 country.
Jinsong Lu, MD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai
Jinsong Lu, MD, lujjss@126.com
Jinsong Lu, Phd
About this study
The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.
- Conditions
- Breast Cancer
- Being tested
- paclitaxel liposome injection plus cisplatin
- 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 injection plus cisplatinDrug
Paclitaxel liposome injection 80 mg/m2, given on days 1, 8,15 and 22 of a 28-day cycle. Cisplatin 25 mg/m2, given on days 1, 8 and 15 of a 28-day cycle, for 4 cycles(4 months)
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel liposome injection plus cisplatin | Other | Not described Receives: Drug: paclitaxel liposome injection plus cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission (pCR) rate
Measured: after 4 months of preoperative treatment
Secondary outcomes (2)
Adverse Events as a Measure of Safety and Tolerability
Measured: 4 months during neoadjuvant therapy
clinical response rate
Measured: after 4 months of preoperative therapy
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 startAug 2014
- Primary completionJun 2015 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 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
- NCT02142010
- Sponsor's protocol ID
- LY-TM-LPS-2014-01
- Status last verified
- Aug 2014
- First submitted
- 9 May 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT02142010
- Acronym / sponsor ID
- LY-TM-LPS-2014-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (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.
The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel liposome injection plus cisplatin | Other | Drug: paclitaxel liposome injection plus cisplatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women aged ≥ 18 years and < 65 years,An estimated life expectancy of at least 12 months
- ECOG 0-1
- At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer, stage II and III, no prior systemic or loco-regional treatment of breast cancer
- Biopsy specimens are available for ER, PgR and Her2 analysis
- Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
Key exclusion criteria (9 listed)
- Patient is pregnant or breast feeding
- Inflammatory breast cancer and Metastatic breast cancer
- Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
- History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
- Has peripheral neuropathy
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 injection plus cisplatinPaclitaxel liposome injection 80 mg/m2, given on days 1, 8,15 and 22 of a 28-day cycle. Cisplatin 25 mg/m2, given on days 1, 8 and 15 of a 28-day cycle, for 4 cycles(4 months) | Drug | paclitaxel liposome injection plus cisplatin |
Primary outcome
pathological complete remission (pCR) rate
Time frame: after 4 months of preoperative treatment
2 secondary outcomes
Adverse Events as a Measure of Safety and Tolerability
Time frame: 4 months during neoadjuvant therapy
clinical response rate
Time frame: after 4 months of preoperative therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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.
Jinsong Lu, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paclitaxel liposome injection plus cisplatin 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 9 inclusion and 9 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 27 Aug 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.
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 Jinsong Lu, MD (lujjss@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete remission (pCR) rate (time frame: after 4 months of preoperative treatment). 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 27 Aug 2014.