JBCRG – Contact Details
Country
Japan
Chair
M. Toi, Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital, 3-18-22, Honkomagome, Bunkyo-ku, TOKYO 113-8677, JAPAN. Tel: +81 3 3823 2101 Email: maktoi77@wa2.so-net.ne.jp
Title
Study of CEF-DOC as primary systemic chemotherapy for operable breast cancer.
Coordinator(s)
M. Toi, Tokyo Medical Center for Cancer and Infectious Diseases, Komagome Hospital, 3-18-22, Honkomagome, Bunkyo-ku, TOKYO 113-8677, JAPAN. Tel: +81 3 3823 2101 Fax: +81 3 3824 1552 Email: maktoi77@wa2.so-net.ne.jp
Summary
- Opened in July 2002
- Target accrual: 200 patients
Primary Objective
- Clinical response, pathological response.
Secondary Objective
- Molecular changes in apoptosis-related molecules, drug-resistance related molecules.
Scheme
Regimen
CEF (500 mg/m2, 100 mg/m2, 500 mg/m2)
q 3 × 4 cycles → Docetaxel (75mg/m2) q 3 × 4 cycles
Update
Closed (reached) target accrual (202). This study forms the basis for other trials of JBCRG; JBCRG02, Phase II neoadjuvant trial looking at the efficacy of FEC followed by docetaxel100 for primary breast cancer patients; JBCRG03, Phase II neoadjuvant trial looking at the efficacy of docetaxel75 followed by FEC for primary breast cancer patients. These studies are registered at the UMIN Clinical Trial Registry (CTR), http://www.umin.ac.jp/english/
Related Publications
Iwata H, Nakamura S, Toi M et al. Interim analysis of a phase II trial of cyclophosphamide,epirubicin and 5-fluorouraci (CEF) followed by docetaxel as preoperative chemotherapy for early stage breast carcinoma. Breast Cancer 2005; 12(2): 99–103.
Kuroi K, Toi M, Tsuda H et al. From the Japan Breast Cancer Research Group (JBCRG): How to define pCR: Our challenge. BIG Newslett 2005; 7(1): 17.
Kuroi K, Toi M, Tsuda H et al. Unargued issues on the pathological assessment of response in primary systemic chemotherapy. Biomed Pharmacother 2005; 59 (Suppl II) (1st OOTR mini-review).
Kuroi K, Toi M, Tsuda H et al. Issues in the assessment of the pathologic effect of primary systemic therapy for breast cancer. Breast cancer 2006; 13(1): 38–48.
Ohno S, Toi M, Kuroi K et al. Update results of FEC followed by docetaxel neoadjuvant trials for primary breast cancer. Biomed Pharmacother 2005; 59 (Suppl II): S323–S324 (1st OOTR).
Topics
- Anthracyclines
- Perioperative chemotherapy
Keywords
Primary systemic chemotherapy, breast cancer
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Title
Study of FEC-DOC100 as primary systemic chemotherapy for operable breast cancer.
Coordinator(s)
S. Nakamura, Breast center, St Luke's International Hospital, 9-1 Akashi, Tyuo-ku, TOKYO 104-8560, JAPAN. Tel: +81 3 3534 5151 Fax: +81 3 55507022 Email: seigonak@luke.or.jp
Summary
- Opened in August 2004
- Target accrual: 30 patients
Primary Objective
- Safety, clinical and pathological effect.
Secondary Objective
- Breast-conserving rate, disease-free survival.
Scheme
Regimen
FEC (500mg/m2, 100mg/m2)
q 3 × 4 cycles → Docetaxel (100mg/m2)
q 3 × 4 cycles
Update
- Closed (reached) target accrual (31). This study is registered at the UMIN Clinical Trial Registry (CTR), http://www.umin.ac.jp/english/
Related Publications
Iwata H, Nakamura S, Toi M et al. Interim analysis of a phase II trial of cyclophosphamide, epirubicin and 5-fluorouraci (CEF) followed by docetaxel as preoperative chemotherapy for early stage breast carcinoma. Breast Cancer 2005; 12(2): 99–103.
Kuroi K, Toi M, Tsuda H et al. From the Japan Breast Cancer Research Group (JBCRG): How to define pCR: Our challenge. BIG Newslett 2005; 7(1): 17.
Kuroi K, Toi M, Tsuda H et al. Unargued issues on the pathological assessment of response in primary systemic chemotherapy. Biomed Pharmacother 2005; 59 (Suppl II) (1st OOTR mini-review).
Kuroi K, Toi M, Tsuda H et al. Issues in the assessment of the pathologic effect of primary systemic therapy for breast cancer. Breast Cancer 2006; 13(1): 38–48.
Ohno S, Toi M, Kuroi K et al. Update results of FEC followed by docetaxel neoadjuvant trials for primary breast cancer. Biomed Pharmacother 2005; 59 (Suppl II): S323–S324 (1st OOTR).
Topics
- Anthracyclines
- Perioperative chemotherapy
Keywords
Primary systemic chemotherapy, breast cancer, pCR
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Title
DOC-FEC as primary systemic chemotherapy.
Coordinator(s)
H. Iwata, Aichi Cancer Center Hospital, Department of Breast Oncology, 1-1 Kanokoden, Chikusa-ku, NAGOYA 464-8681, JAPAN. Tel: +81 52 762 6111 Fax: +81 52 764 2963 Email: hiwata@aichi-cc.jp
Summary
- Opened in October 2005
- Target accrual: 130 patients
Primary Objective
- Pathological response, safety.
Secondary Objective
- Clinical response, breast-conserving rate, overall survival, disease-free survival.
Scheme
Regimen:
Docetaxel (75mg/m2)
q 3 × 4 cycles → FEC (500mg/m2, 100mg/m2) q 3 × 4 cycles
Update
- Ongoing.
- This study is registered at UMIN Clinical Trial Registry (CTR), http://www.umin.ac.jp/english/
Related Publications
Iwata H, Nakamura S, Toi M et al. Interim analysis of a phase II trial of cyclophosphamide, epirubicin and 5-fluorouraci (CEF) followed by docetaxel as preoperative chemotherapy for early stage breast carcinoma. Breast Cancer 2005; 12(2): 99–103.
Kuroi K, Toi M, Tsuda H et al. From the Japan Breast Cancer Research Group (JBCRG): How to define pCR: Our challenge. BIG Newslett 2005; 7(1): 17.
Kuroi K, Toi M, Tsuda H et al. Unargued issues on the pathological assessment of response in primary systemic chemotherapy. Biomed Pharmacother 2005; 59 (Suppl II) (1st OOTR mini-review).
Kuroi K, Toi M, Tsuda H et al. Issues in the assessment of the pathologic effect of primary systemic therapy for breast cancer. Breast Cancer 2006; 13(1): 38–48.
Ohno S, Toi M, Kuroi K et al. Update results of FEC followed by docetaxel neoadjuvant trials for primary breast cancer. Biomed Pharmacother 2005; 59 (Suppl II): S323–S324 (1st OOTR).
Topics
- Anthracyclines
- Perioperative chemotherapy
Keywords
Primary systemic chemotherapy, breast cancer
