Status:
UNKNOWN
Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer
Lead Sponsor:
Taizhou Hospital
Conditions:
Breast Cancer
Paclitaxel
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 (C...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \-
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01848197
Start Date
May 1 2013
End Date
December 1 2020
Last Update
May 7 2013
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