A randomized study of Docetaxel + Cyclophosphamide (TC), 5-fluorouracil + Epirubicin + Cyclophosphamide (FEC)-TC and TC-FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer JBCRG-09
- Conditions
- hormone receptor positive and HER2 negative primary breast cancer
- Registration Number
- JPRN-UMIN000003283
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
pCR (CpCR + ypN0) rates were 9.2%, 8.1%, and 15.9% in the FEC-TC, TC-FEC, and TC6 groups, respectively. ORRs were 72.8% in the FEC-TC group (CR 12.3%), 73.0% in the TCFEC group (CR 4.8%), and 75.4% in the TC6 group (CR15.4%). pCR rates in the three groups were similar, but the breast conservation rate was significantly higher in the TC6 group than in the others.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 195
Not provided
1)Hypersensitivity to any agents necessary in the planned treatment. 2)Poorly controlled complication (malignant hypertension, myocardial infarction within 6 months, congestive heart failure, coronary insufficiency, arrhythmia which requires treatment, infection and bleeding). 3)Fever with suspected infection. 4)Symptoms of varicella. 5)Pleural effusion or cardiac effusion which requires treatment. 6)Serious edema. 7)Serious peripheral neuropathy 8)Complication which requires prior treatment with corticosteroid. 9)Regular use of H2 blocker. 10)Has history of or receiving treatment for serious psychiatric disorder case. 11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 12)History of invasive breast cancer. 13)Multiple primary cancer .However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer. 14)History of multiple primary cancers in the past 5 years, excluding nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer appropriately treated. 15)Prior treatment with anticancer case. 16)Women who are pregnant, lactating or with childbearing potential. 17)Ineligible based on decision of an investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathological complete rseponse rate
- Secondary Outcome Measures
Name Time Method Safety,Overall response rate,Disease-free survival,Overall surviva, Clinical response evaluation using various diagnostic imaging techniques