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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00379015
First received: September 19, 2006
Last updated: December 17, 2013
Last verified: July 2009
  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
Biological: trastuzumab
Drug: cyclophosphamide
Drug: docetaxel
Drug: epirubicin hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

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

Resource links provided by NLM:


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
Study Completion Date: September 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Shikoku Cancer Center
Matsuyama-shi, Ehime, Japan, 791-0288
National Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan, 811-1395
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Keio University Hospital
Tokyo, Japan, 160-8582
Teikyo University School of Medicine
Tokyo, Japan, 173-8605
Sponsors and Collaborators
Teikyo University
Investigators
Study Chair: Tadashi Ikeda, MD Teikyo University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00379015     History of Changes
Other Study ID Numbers: CDR0000496448, TUSM-BRI-BC04-01
Study First Received: September 19, 2006
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Trastuzumab
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014