Breast Cancer, Cyclophosphamide, Epirubicin, Paclitaxel
Conditions
Brief summary
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.
Interventions
DRUGpaclitaxel
Sponsors
Taizhou Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 3 years | time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 5 years | time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer. |
| overall survival | 5 years | time from randomization to disease death with/without recurrence breast cancer. |
Other
| Measure | Time frame |
|---|---|
| Explore the relationship between neuropathy and DFS and the related predictive biomarkers (RWDD3 and TECTA gene SNP etc) | 3 years |
| Explore predictive biomarker of neutropenia; | 5 years |
Outcome results
None listed