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

NCT02142790 | Unknown Phase 4

• 1 other identifier: LY-TM-LPS-2014-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  24 months

Secondary Outcomes (3)

• Overall Response Rate

  24 months

• Clinical Benefit Rate

  24 months

• Adverse Events

  24 months

Study Arms (2)

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

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

Drug: paclitaxel liposome injection

Interventions

paclitaxel liposome injection DRUG

Also known as: LIPUSU

paclitaxel liposome injection every 3 weeks; paclitaxel liposome injection weekly

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Luye Sike Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Quchang Ouyang, MD

CONTACT

oyqc1969@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2016
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

CN (1)