Overview

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