Unique ID issued by UMIN | C000000011 |
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Receipt number | R000000020 |
Scientific Title | Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer |
Date of disclosure of the study information | 2005/06/22 |
Last modified on | 2019/11/21 15:58:03 |
Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer
JBCRG-01
(Study of CEF-DOC as primary systemic chemotherapy for operable berast cancer)
Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer
JBCRG-01
(Study of CEF-DOC as primary systemic chemotherapy for operable berast cancer)
Japan |
Primary breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
The purpose of this study is to evaluate the feasibility and safety as well as clinical and pathological response of cyclophosphamide, epirubicin and fluorouracil (CEF) followed by docetaxel (DOC) as primary systemic chemotherapyin patients with operable breast cancer
Safety,Efficacy
Confirmatory
Phase II
Clinicl response, pathologic response, safety
Breast-conserving rate, overall survival, disease free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
Primary systemic chemotherapy (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and fluorouracil 500 mg/m2, q3w x 4 cycles, followed by docetaxel 75 mg/m2, q3w x 4 cycles
20 | years-old | <= |
65 | years-old | >= |
Female
Histologically-proven breast cancer
T1c-3N0M0/T1-3N1M0
No prior therapy for breast cancer
Performance status 0-1
Adequate hematologic, renal, hepatic and cardiac function
Written informed consent
Hypersensitivity for drug
Serious coexisting illness
Active double cancer
Bilateral breast cancer
Male breast cancer
Pregnant or postpartum women
200
1st name | 1)Masakazu 2)Yuichi |
Middle name | |
Last name | 1)Toi 2)Takatsuka |
1)Graduate School of Medicine Kyoto University 2)Kansai Rosai Hospital
1)Department of Surgery (Breast Surgery) 2)Department of Breast Surgery
606-8507
54 Kawara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
075-751-3660
toi@kuhp.kyoto-u.ac.jp
1st name | Katsumasa |
Middle name | |
Last name | Kuroi |
JBCRG
Head Office
103-0016
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
03-6264-8873
https://jbcrg.jp/
office@jbcrg.jp
Japan Breast Cancer Research Group (JBCRG)
Osaka Cancer Research Foundation, Advanced Clinical Research Organization
Non profit foundation
JBCRG
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
03-6264-8873
office@jbcrg.jp
NO
2005 | Year | 06 | Month | 22 | Day |
Published
Totally 202 patients were enrolled, and final clinical resposne, safety and pCR data were published (Breast Cancer Res Treat. 2007).
Completed
2002 | Year | 06 | Month | 10 | Day |
2002 | Year | 06 | Month | 01 | Day |
2007 | Year | 01 | Month | 01 | Day |
2007 | Year | 01 | Month | 01 | Day |
2007 | Year | 01 | Month | 01 | Day |
2007 | Year | 03 | Month | 01 | Day |
Presentation: The 11th Annual Meeting of Jpn Breast Cancer Soc (2003), The 41st Annual Meeting of Jpn Soc for Cancer Ther (2003), The 15th ICACT(2004), The 12th Annual Meeting of Jpn Breast Cancer Soc (2004), The 1st Annual Meeting of OOTR (2004), The 27th SABCS(2004), The 13th Annual Meeting of Jpn Breast Cancer Soc (2005),5th EBCC(2006), 3rd OOT(2006)
Papers:Breast Cancer (12:99-103, 2005)
2005 | Year | 06 | Month | 14 | Day |
2019 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000020
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