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Status:

COMPLETED

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

Lead Sponsor:

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Conditions:

Breast Cancer

Eligibility:

FEMALE

20-65 years

Phase:

PHASE2

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 fr...

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 foll...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2016

    Estimated Enrollment :

    38 Patients enrolled

    Trial Details

    Trial ID

    NCT00379015

    Start Date

    January 1 2006

    End Date

    March 1 2016

    Last Update

    September 28 2016

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Shikoku Cancer Center

    Matsuyama, Ehime, Japan, 791-0288

    2

    National Kyushu Cancer Center

    Fukuoka, Fukuoka, Japan, 811-1395

    3

    Keio University Hospital

    Tokyo, Tokyo, Japan, 160-8582

    4

    Teikyo University School of Medicine

    Tokyo, Tokyo, Japan, 173-8605