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Trial Title:
A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
NCT ID:
NCT01351597
Condition:
Recurrent Breast Cancer
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Recurrence
Docetaxel
Oxaliplatin
Conditions: Keywords:
recurrent breast cancer
metastatic breast cancer
docetaxel
oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
docetaxel/ oxaliplatin
Description:
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
Arm group label:
docetaxel/ oxaliplatin
Other name:
Detaxel®
Other name:
oxalitin®
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Address:
City:
Seoul
Zip:
139-707
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sehwan Han, MD. PhD.
Phone:
82-2-950-1018
Email:
hanse@paik.ac.kr
Start date:
April 2011
Completion date:
September 2013
Lead sponsor:
Agency:
Korean Breast Cancer Study Group
Agency class:
Other
Source:
Korean Breast Cancer Study Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01351597
