Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: trastuzumab (Biological); cyclophosphamide (Drug); docetaxel (Drug); epirubicin hydrochloride (Drug); conventional surgery (Procedure); neoadjuvant therapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Teikyo University Official(s) and/or principal investigator(s): Tadashi Ikeda, MD, Study Chair, Affiliation: Teikyo University
Summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor
growth in different ways. Some block the ability of tumor cells to grow and spread. Others
find tumor cells and help kill them or carry tumor-killing substances to them. Giving
chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce
the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide
followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB,
stage IIIC, or stage IV primary breast cancer.
Clinical Details
Official title: Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer
Study design: Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pathological complete response
Secondary outcome: Clinical responseRecurrence-free survival Overall survival Adverse event
Detailed description:
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.
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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
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
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
Locations and Contacts
Niigata Cancer Center Hospital, Niigata 951-8566, Japan
Keio University Hospital, Tokyo 160-8582, Japan
Teikyo University School of Medicine, Tokyo 173-8605, Japan
Shikoku Cancer Center, Matsuyama-shi, Ehime 791-0288, Japan
National Kyushu Cancer Center, Fukuoka-shi, Fukuoka 811-1395, Japan
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2006
Last updated: December 17, 2013
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