Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 20 to 65 | Other | TUSM-BRI-BC04-01 NCT00379015 |
Objectives
Primary
- 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
- Determine the clinical response in patients treated with this regimen.
- Determine the recurrence-free survival of patients treated with this regimen.
- 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
40A total of 40 patients will be accrued for this study.
Outcomes
Primary Outcome(s)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 Lead Organizations
Teikyo University School of Medicine
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| Tadashi Ikeda, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined with Trastuzumab for the Patients with HER-Positive Advanced Breast Cancer | |
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| Trial Start Date | 2006-01-01 | |
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| Trial Completion Date | 2009-06-30 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00379015 | |
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| Date Submitted to PDQ | 2006-07-20 | |
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| Information Last Verified | 2009-07-05 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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