Breast Cancer
Conditions
Keywords
stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Brief 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.
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.
Interventions
BIOLOGICALtrastuzumab
DRUGcyclophosphamide
DRUGdocetaxel
DRUGepirubicin hydrochloride
PROCEDUREconventional surgery
PROCEDUREneoadjuvant therapy
Sponsors
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab | Pathological complete response is assessed in surgical resected specimens of primary tumor from patients who underwent a primary radical surgery in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | From 7 days after the last adoministration of neosdjuvant therapy of Trastuzumab until surgery. | Clinical response is assessed as overall response in target lesion of primary tumor from 7 days after the last administration of neoadjuvant therapy of Trastuzumab until surgery. |
| Pathological response of axillary lymph nodes | Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab. | Pathological response of axillary lymph nodes is assessed in surgical specimens of primary tumor from patients who underwent a primary radical surgery in this study. |
| Recurrence-free survival | 8 years | Recurrence-free survival is defined as time from date of enrollment until date of recurrence or death from any cause, whichever comes first. |
| Overall survival | 8 years | Overall survival is defined as time from date of enrollment until date of death from any cause. |
| Adverse event | 70 months | Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center. |
Countries
Japan
Outcome results
None listed