Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: Female

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 estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Capecitabine; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• 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:

1. Absolute granulocyte count >=1500/mm3,

2. platelet >=100,000/mm3, Hemoglobin >=10 g/mm3

• Adequate renal function: Serum creatinine <=1.5 mg/dl

• Adequate hepatic function:

1. total bilirubin: <=1.5 mg/dl

2. AST/ALT: <=three times normal

3. Alkaline phosphatase: <=three times normal

• Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment

Exclusion Criteria:

• 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