Trial Information
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Byung-Joo Song, MD.PhD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Catholoic university of Korea, St. Mary's hospital.
Authority:
Korea: Food and Drug Administration
Study ID:
KBCSG004
NCT ID:
NCT00912639
Start Date:
May 2009
Completion Date:
May 2011
Related Keywords:
- Recurrent Breast Cancer
- recurrent breast cancer
- Genexol-PM
- Breast Neoplasms