Weekly and Every 3 Week Administration of Paclitaxel Liposome Injection in Metastatic Breast Cancer

Phase 4

• Conditions: Breast Cancer
• Interventions: Drug: paclitaxel liposome injection

• Registration Number: NCT02142790
• Lead Sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-20
• Last Update Posted: 2014-07-22
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paclitaxel liposome injection every 3 weeks	paclitaxel liposome injection	paclitaxel liposome injection 175mg/m2 administered by intravenous on day1 of a 21-day cycle for at least 4cycles or till progression or intolerable
paclitaxel liposome injection weekly	paclitaxel liposome injection	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

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	24 months

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit Rate	24 months
Overall Response Rate	24 months
Adverse Events	24 months

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China