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.
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
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:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
Outcome Time Frame:
Byung-Joo Song, MD.PhD.
The Catholoic university of Korea, St. Mary's hospital.
Korea: Food and Drug Administration
- Recurrent Breast Cancer
- recurrent breast cancer
- Breast Neoplasms