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

Sponsored by:	Teikyo University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00379015

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: trastuzumab Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Docetaxel Epirubicin hydrochloride Epirubicin Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pathological complete response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response [ Designated as safety issue: No ]
Recurrence-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Adverse event [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379015

Locations

Japan
Niigata Cancer Center Hospital	Recruiting
Niigata, Japan, 951-8566
Contact: Nobuaki Sato, MD 81-25-266-5111 nobus@niigata-cc.jp
Keio University Hospital	Recruiting
Tokyo, Japan, 160-8582
Contact: Hiromitsu Jinno, MD 81-3-3353-1211 ext. 62334 jinno@sc.itc.keio.ac.jp
Teikyo University School of Medicine	Recruiting
Tokyo, Japan, 173-8605
Contact: Tadashi Ikeda, MD 81-3-3964-1231 ikedat@med.teikyo-u.ac.jp
Japan, Ehime
Shikoku Cancer Center	Recruiting
Matsuyama-shi, Ehime, Japan, 791-0288
Contact: Kenjiro Aogi, MD 81-89-999-1111 kaogi@shikoku-cc.go.jp
Japan, Fukuoka
National Kyushu Cancer Center	Recruiting
Fukuoka-shi, Fukuoka, Japan, 811-1395
Contact: Shinji Ohno, MD 81-92-541-3231 sohno@nk-cc.go.jp

Sponsors and Collaborators

Teikyo University

Investigators

Study Chair:

Tadashi Ikeda, MD

Teikyo University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000496448, TUSM-BRI-BC04-01
Study First Received:	September 19, 2006
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00379015
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Trastuzumab
Breast Neoplasms

Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009