Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer
- Conditions
- Breast CancerPaclitaxelEpirubicinCyclophosphamide
- Interventions
- Registration Number
- NCT01848197
- Lead Sponsor
- Taizhou Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1000
- Age between 18-70 years female operable breast cancer patients
- Patients were required to register within 60 days from the final surgical procedure required to adequately treat the invasive primary tumor.
- 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.
- Karnofsky points greater than or equal to 70.
- Postmenopausal women or HCG test results were negative, Women of child-bearing potential willing to use effective contraception during the study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EC-P2 paclitaxel all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 2-week intervals for 4 cycles. EC-P1 paclitaxel all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 1-week intervals for 12 cycles.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.