A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
NCT ID: NCT01351597
Last Updated: 2011-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
51 participants
INTERVENTIONAL
2011-04-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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docetaxel/ oxaliplatin
All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.
docetaxel/ 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
Interventions
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docetaxel/ 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
70 Years
FEMALE
No
Sponsors
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Korean Breast Cancer Study Group
OTHER
Responsible Party
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Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Principal Investigators
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Sehwan Han, MD.PhD.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
Locations
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Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KBCSG008
Identifier Type: -
Identifier Source: org_study_id
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