Recurrent Breast Cancer
Conditions
Keywords
recurrent breast cancer, Genexol-PM
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.
Interventions
DRUGPaclitaxel loaded Polymeric micelle
Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.
Sponsors
Korean Breast Cancer Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | 1 year |
| Progression Free Survival | 1 year |
| Tumor control rate | 1 year |
Countries
South Korea
Outcome results
None listed