Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 20 to 65 Other TUSM-BRI-BC04-01 NCT00379015

Objectives

Primary

1. Determine the pathological complete response in women with HER2-positive stage IIIB-IV breast cancer treated with neoadjuvant epirubicin hydrochloride and cyclophosphamide followed by docetaxel and trastuzumab (Herceptin®).

Secondary

1. Determine the clinical response in patients treated with this regimen.
2. Determine the recurrence-free survival of patients treated with this regimen.
3. Determine the overall survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Diagnosis of primary breast cancer
  • Stage IIIB, IIIC, or IV disease



• No inflammatory disease



• HER2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization



• Hormone receptor status known

Prior/Concurrent Therapy:

• No prior surgery except for biopsy
• No prior or concurrent chemotherapy and/or hormonal therapy
• No prior or concurrent biological therapy
• No prior or concurrent radiotherapy except postoperative radiotherapy

Patient Characteristics:

• Female
• Menopausal status not specified
• Performance status 0-1
• WBC ≤ 10,000/mm³
• Absolute neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.5 g/dL
• SGOT/SGPT ≤ 60 IU/L
• Bilirubin ≤ 1.5 mg/dL
• Creatinine ≤ 1.5 mg/dL
• LVEF ≥ 55%
• No signs of pneumonitis

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outcomes

Pathological complete response

Clinical response
Recurrence-free survival
Overall survival
Adverse event

Outline

This is a multicenter study.

Patients receive epirubicin hydrochloride and cyclophosphamide in weeks 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses.

Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.

Trial Contact Information

Trial Lead Organizations

Teikyo University School of Medicine

Tadashi Ikeda, MD, Protocol chair		Ph: 81-3-3964-1231 Email: ikedat@med.teikyo-u.ac.jp

Japan
	Niigata
	Niigata Cancer Center Hospital
		Nobuaki Sato, MD	Ph:  81-25-266-5111
			Email: nobus@niigata-cc.jp
Ehime
	Matsuyama-shi
	Shikoku Cancer Center
		Kenjiro Aogi, MD	Ph:  81-89-999-1111
			Email: kaogi@shikoku-cc.go.jp
Fukuoka
	Fukuoka-shi
	National Kyushu Cancer Center
		Shinji Ohno, MD	Ph:  81-92-541-3231
			Email: sohno@nk-cc.go.jp
Tokyo
	Tokyo
	Keio University Hospital
		Hiromitsu Jinno, MD	Ph:  81-3-3353-1211 ext. 62334
			Email: jinno@sc.itc.keio.ac.jp
	Teikyo University School of Medicine
		Tadashi Ikeda, MD	Ph:  81-3-3964-1231
			Email: ikedat@med.teikyo-u.ac.jp

Registry Information
Official Title		Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined with Trastuzumab for the Patients with HER-Positive Advanced Breast Cancer
Trial Start Date		2006-01-01
Trial Completion Date		2009-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00379015
Date Submitted to PDQ		2006-07-20
Information Last Verified		2008-04-10

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