Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer
Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer
RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse
 and death in women with operable breast cancer.In the North American Inter-Group factorial
 trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested
 in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant
 chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival
 in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals
 (supported by the use of granulocyte-colony stimulating factor) were better than the
 conventional inconvenient weekly intervals.
Inclusion Criteria:

 1. Age between 18-70 years female operable breast cancer patients

 2. Patients were required to register within 60 days from the final surgical procedure
 required to adequately treat the invasive primary tumor.

 3. women who had operable,histologically confirmed adenocarcinoma of the breast with a.
 histologically involved positive lymph nodes b. or histologic diagnosis for three
 negative patients; c. or lymph node negative, HER2 positive(if HER2 + +, FISH
 (fluorescence in situ hybridization method)/CISH tests confirmed HER2 amplification is
 positive),but unable or intolerant to herceptin combined chemotherapy.

 4. Karnofsky points greater than or equal to 70.

 5. Postmenopausal women or HCG test results were negative, Women of child-bearing
 potential willing to use effective contraception during the study.

 6. PATIENT CHARACTERISTICS:

 Hematopoietic:

 -  Neutrophil count at least 1,500/mm^3

 -  Platelet count at least 100,000/mm^3

 Hepatic:

 -  Bilirubin no greater than 1.5 times upper limit of normal

 -  TBIL no greater than 1.5 times upper limit of normal

 -  AKP no greater than 2.5 times upper limit of normal

 -  AST no greater than 2.5 times upper limit of normal

 -  ALT no greater than 2.5 times upper limit of normal

 Renal:

 -  Creatinine no greater than 1.5 times upper limit of normal

 Cardiovascular:

 -  No history of myocardial infarction

 -  No congestive heart failure

 -  No significant ischemic or valvular heart disease

 Other:

 -  No other prior invasive malignancies within the past 5 years except curatively treated
 basal or squamous cell skin cancer or carcinoma in situ of the cervix

 -  No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs
 (with Cremophor or polysorbate)

 Other protocol-defined inclusion/exclusion criteria may apply.

 Exclusion Criteria:

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