Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer


Phase 2
20 Years
65 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response

Safety Issue:

No

Principal Investigator

Tadashi Ikeda, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Teikyo University

Authority:

United States: Federal Government

Study ID:

CDR0000496448

NCT ID:

NCT00379015

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

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