A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer

Phase 4

• Conditions: Recurrent Breast Cancer
• Interventions: Drug: Paclitaxel loaded Polymeric micelle

• Registration Number: NCT00912639
• Lead Sponsor: Korean Breast Cancer Study Group

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 survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-31
• Status Verified: 2009-06
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Last Update Submitted: 2009-06-15
• Last Update Posted: 2009-06-16
• Primary Completion: 2010-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1. Women aged >=18 years
2. WHO (ECOG) performance status 0-2
3. Estimated life expectancy of >=3 months
4. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria

1. Patients with previous chemotherapy for recurrent breast cancer
2. Breast cancer recurrence within 12 months after taxane treatment
3. Her-2/neu expression
4. 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.
5. Brain metastasis
6. uncontrolled infection, medically uncontrollable heart disease
7. other serious medical illness or prior malignancies
8. Pregnant or lactating women were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genexol-PM	Paclitaxel loaded Polymeric micelle	All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion) 1. Spiral CT : lesion ≥ 10mm (unidimension) 2. X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension)

Primary Outcome Measures

Name	Time	Method
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline	1 year

Secondary Outcome Measures

Name	Time	Method
Tumor control rate	1 year
Toxicity	1 year
Progression Free Survival	1 year

Trial Locations

Locations (1)

Department of surgery, The Catholoic university of Korea, St. Mary's hospital.; 🇰🇷 Seoul, Korea, Republic of