Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Not Applicable
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000020693
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Poorly controlled complication (malignant hypertension, myocardial infarction , congestive heart failure, bleeding). 2)Multiple primary cancer 3)Synchronous bilateral breast cancer 4)Interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan. 5)Women who are pregnant, lactating or with childbearing potential 6)Hypersensitivity to any agents necessary in the planned treatment. 7)Serious peripheral neuropathy or serious edema 8)Pleural effusion or cardiac effusion which requires treatment 9)Complication which requires prior treatment with corticosteroid 10)Suspected infection 11)Ineligible based on decision of an investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathological complete response
- Secondary Outcome Measures
Name Time Method response rate the rates of breast conserving surgery dosease free survival overall survival side effects