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

NCT ID: NCT00379015

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HER2 over-expressing primary breast cancer group

Patients receive epirubicin hydrochloride and cyclophosphamide in week 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.

Group Type: EXPERIMENTAL

trastuzumab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Interventions

trastuzumab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tadashi Ikeda, MD

Role: STUDY_CHAIR

Teikyo University

Locations

Shikoku Cancer Center

Matsuyama, Ehime, Japan

National Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Keio University Hospital

Tokyo, Tokyo, Japan

Teikyo University School of Medicine

Tokyo, Tokyo, Japan

Niigata Cancer Center Hospital

Niigata, , Japan

Countries

Japan

Other Identifiers

TUSM-BRI-BC04-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000496448

Identifier Type: -

Identifier Source: org_study_id