- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02142010
Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer
August 26, 2014 updated by: Nanjing Luye Sike Pharmaceutical Co., Ltd.
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jinsong Lu, MD
- Email: lujjss@126.com
Study Locations
-
-
-
Shanghai, China
- Recruiting
- shanghai Jiaotong University School of Medicine, Renji Hospital
-
Contact:
- Jinsong Lu, MD
- Email: lujjss@126.com
-
Principal Investigator:
- Jinsong Lu, Phd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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;
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: paclitaxel liposome injection plus cisplatin
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pathological complete remission (pCR) rate
Time Frame: after 4 months of preoperative treatment
|
after 4 months of preoperative treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events as a Measure of Safety and Tolerability
Time Frame: 4 months during neoadjuvant therapy
|
4 months during neoadjuvant therapy
|
clinical response rate
Time Frame: after 4 months of preoperative therapy
|
after 4 months of preoperative therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
May 9, 2014
First Submitted That Met QC Criteria
May 19, 2014
First Posted (Estimate)
May 20, 2014
Study Record Updates
Last Update Posted (Estimate)
August 27, 2014
Last Update Submitted That Met QC Criteria
August 26, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LY-TM-LPS-2014-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
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