Metastatic Breast Cancer, Recurrent Breast Cancer
Conditions
Keywords
recurrent breast cancer, metastatic breast cancer, docetaxel, oxaliplatin
Brief summary
The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.
Detailed description
Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.
Interventions
DRUGdocetaxel/ oxaliplatin
1. docetaxel - 75 mg/m2 with D5W250ml IV (in the vein)over 1 hr, every 3 weeks 2. oxaliplatine - 70 mg/m2 with D5W250ml IV (in the vein)over 2 hrs, every 3 weeks
Sponsors
Korean Breast Cancer Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged : 20\ 70 years 2. WHO (ECOG) performance status 0-2 3. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline 4. patients had previously not received chemotherapy of recurrent or metastatic lesion. 5. 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 breast cancer 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 |
|---|---|
| overall response rate | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival | 2 years |
| toxicity | 2 years |
| quality of life | 2 years |
Countries
South Korea
Contacts
Primary ContactKu Sang Kim, M.D.
Outcome results
None listed