Status:
UNKNOWN
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
Lead Sponsor:
Korean Breast Cancer Study Group
Conditions:
Recurrent Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
Detailed Description
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free ...
Eligibility Criteria
Inclusion
- Women aged \>=18 years
- WHO (ECOG) performance status 0-2
- Estimated life expectancy of \>=3 months
- Have given written informed consent and are available for prolonged follow-up
Exclusion
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
- uncontrolled infection, medically uncontrollable heart disease
- other serious medical illness or prior malignancies
- Pregnant or lactating women were excluded.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00912639
Start Date
May 1 2009
End Date
May 1 2011
Last Update
June 16 2009
Active Locations (1)
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1
Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
Seoul, South Korea