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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 (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00379015
First received: September 19, 2006
Last updated: September 27, 2016
Last verified: September 2016
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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 Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Pathological complete response [ Time Frame: Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab ] [ Designated as safety issue: No ]
    Pathological complete response is assessed in surgical resected specimens of primary tumor from patients who underwent a primary radical surgery in this study.


Secondary Outcome Measures:
  • Clinical response [ Time Frame: From 7 days after the last adoministration of neosdjuvant therapy of Trastuzumab until surgery. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Overall survival is defined as time from date of enrollment until date of death from any cause.

  • Adverse event [ Time Frame: 70 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 38
Study Start Date: January 2006
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Biological: trastuzumab Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy

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   (Adult)
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
Translational Research Informatics Center, Kobe, Hyogo, Japan
Investigators
Study Chair: Tadashi Ikeda, MD Teikyo University
  More Information

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00379015     History of Changes
Other Study ID Numbers: CDR0000496448  TUSM-BRI-BC04-01 
Study First Received: September 19, 2006
Last Updated: September 27, 2016
Health Authority: Translational Research Informatics Center Ethical Committiee: Japan

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

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

ClinicalTrials.gov processed this record on December 05, 2016