National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Phase II Study of Neoadjuvant Epirubicin Hydrochloride and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin®) in Women With HER2-Positive Stage IIIB-IV Breast Cancer
Last Modified: 4/3/2008     First Published: 9/15/2006  

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive20 to 65OtherTUSM-BRI-BC04-01
NCT00379015

Objectives

Primary

  1. 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

  1. Determine the clinical response in patients treated with this regimen.
  2. Determine the recurrence-free survival of patients treated with this regimen.
  3. Determine the overall survival of patients treated with this regimen.

Entry 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


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

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

Expected Enrollment

40

A total of 40 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Pathological complete response

Secondary Outcome(s)

Clinical response
Recurrence-free survival
Overall survival
Adverse event

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.

Trial Contact Information

Trial Lead Organizations

Teikyo University School of Medicine

Tadashi Ikeda, MD, Protocol chair
Ph: 81-3-3964-1231
Email: ikedat@med.teikyo-u.ac.jp

Trial Sites

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

Registry Information
Official Title Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined with Trastuzumab for the Patients with HER-Positive Advanced Breast Cancer
Trial Start Date 2006-01-01
Trial Completion Date 2009-06-30 (estimated)
Registered in ClinicalTrials.gov NCT00379015 1
Date Submitted to PDQ 2006-07-20
Information Last Verified 2009-07-05

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00379015