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Herceptin and Paclitaxel in Locally Advanced Breast Cancer With Her-2 Overexpression

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Herceptin and Paclitaxel in Locally Advanced Breast Cancer With Her-2 Overexpression

OBJECTIVES: I. Determine the safety and toxicity of preoperative trastuzumab (Herceptin) and
paclitaxel followed by postoperative doxorubicin and cyclophosphamide in women with locally
advanced breast cancer with HER2 overexpression. II. Determine tumor response in these
patients treated with this regimen. III. Assess the effect of this regimen on tumor
histology and the potential molecular determinants of response in these patients.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes followed by
paclitaxel IV over 60 minutes on day 1. Treatment continues every 7 days for a total of 10
courses in the absence of disease progression or unacceptable toxicity. Patients undergo a
modified radical mastectomy or a lumpectomy with axillary node dissection. Beginning 14 days
after surgery, patients receive doxorubicin IV and cyclophosphamide IV over 15-30 minutes on
day 1. Treatment repeats every 21 days for a total of 4 courses. After completion of
chemotherapy, patients with hormone receptor-positive disease receive oral tamoxifen daily
for 5 years. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Palpable primary breast cancer at least 3 cm (T2 at least 3 cm,
T3-T4, any N) No distant metastasis (M0) HER2 overexpression of 2+ or 3+ by
immunohistochemistry performed on core biopsy specimen using the Dako Hercep Test Hormone
receptor status: Status known

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal Status: Premenopausal or
postmenopausal Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic:
Absolute neutrophil count at least 1,500/mm3 Platelet count at least 150,000/mm3
Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no
greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular:
Ejection fraction normal by MUGA No history of congestive heart failure, myocardial
infarction, arrhythmia, or ischemic heart disease Other: No other prior malignancy except
basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or
nursing Fertile patients must use effective barrier contraception during and for 2 months
after study No pre-existing clinically significant peripheral neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Matthew D. Volm, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016