Clinical trial NCT00379015: Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer
Official title: Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
First posted: 2006-09-21
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pathological complete response
timeFrame: Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab
Secondary outcomes:
measure: Clinical response
timeFrame: From 7 days after the last adoministration of neosdjuvant therapy of Trastuzumab until surgery.
measure: Pathological response of axillary lymph nodes
timeFrame: Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab.
measure: Recurrence-free survival
timeFrame: 8 years
measure: Overall survival
timeFrame: 8 years
measure: Adverse event
timeFrame: 70 months
Other outcomes:
Locations:
city: Matsuyama-shi
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Teikyo University School of Medicine
Study officials:
affiliation: Teikyo University
name: Tadashi Ikeda, MD
role: STUDY_CHAIR
References: