Status:
COMPLETED
Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for ...
Detailed Description
\- Patients will be randomized to receive regimen A (AC) and regimen B(TX), preoperatively,as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous in...
Eligibility Criteria
Inclusion
- All patients must have histologically confirmed and newly diagnosed breast cancer: stage II and III breast cancer.
- PET results will determine node positivity.
- No prior hormonal , chemotherapy or radiotherapy is allowed.
- No breast operation other than biopsy to make diagnosis is allowed.
- Age:18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
- Adequate hematopoietic function:
- Absolute granulocyte count \>=1500/mm3,
- platelet \>=100,000/mm3, Hemoglobin \>=10 g/mm3
- Adequate renal function: Serum creatinine \<=1.5 mg/dl
- Adequate hepatic function:
- total bilirubin: \<=1.5 mg/dl
- AST/ALT: \<=three times normal
- Alkaline phosphatase: \<=three times normal
- Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
Exclusion
- Patients who received hormonal , chemotherapy or radiotherapy for breast cancer
- Patients who underwent surgery for breast cancer
- Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT00352378
Start Date
June 1 2002
End Date
January 1 2006
Last Update
June 27 2011
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