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: [email protected]

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: [email protected]

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: [email protected]

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

***************************************************

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: [email protected]

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