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JBCRG-09
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
- Status
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Study Closed
- Objectives
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To evaluate the efficacy and safety of 6 cycles of docetaxel and cyclophosphamide (TC), 3 cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) followed by 3 cycles of TC (FEC-TC), and 3 cycles of TC followed by 3 cycles of FEC as preoperative chemotherapy in patients with hormone receptor positive and HER2 negative primary breast cancer randomized to receive either of these therapies
- Subjects
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- Endpoints
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Primary Endpoint: Pathological complete response, Secondary endpoints : Safety, Overall response rate, Disease-free Survival, Overall survival, Clinical response evaluation using various diagnostic imaging techniques
- Trial Period
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Registration: 3 years (Sep 2009-Aug 2012)
Follow-up: 5 years from LPI
- Lead Principal Investigator
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Masakazu Toi (Department of Surgery, Breast Surgery, Graduate School of Kyoto University), Norikazu Masuda(Department of Surgery, Osaka National Hospital)
- Target Sample Size
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195 (65 per group)
- Regimen
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- Source of Funding
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JBCRG
- Conference Presentation
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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: Japan Breast Cancer Research Group (JBCRG) – 09
- Articles and Publications
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A randomized study comparing docetaxel/cyclophosphamide (TC), 5-fluorouracil/epirubicin/cyclophosphamide (FEC) followed by TC, and TC followed by FEC for patients with hormone receptor-positive HER2-negative primary breast cancer (JBCRG-09)
- UMIN-ID
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UMIN000003283
- jRCT
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- Memo
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- COI Disclosure
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