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Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer


OBJECTIVES:

- Determine the pharmacokinetics and pharmacodynamics of trastuzumab (Herceptin) and
paclitaxel in patients with HER2-overexpressing metastatic breast cancer.

- Provide access to trastuzumab and paclitaxel for these patients.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes and paclitaxel IV
over 1 hour weekly. Patients receive trastuzumab alone during course 1 and then in
combination with paclitaxel during subsequent courses. Courses repeat every 4 weeks until
patients achieve a sustained complete response of 8 weeks or disease progression occurs.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic breast cancer with HER2
overexpression

- Radiographically or physically measurable disease that can be biopsied safely under
local anesthesia

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Male or female

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

Hepatic:

- Bilirubin no greater than 3 times upper limit of normal (ULN)

- AST and ALT no greater than 5 times ULN

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior trastuzumab

Chemotherapy:

- Not specified

Endocrine therapy:

- At least 2 weeks since prior hormonal therapy

- No concurrent hormone receptor therapy (e.g., tamoxifen or armidex)

Radiotherapy:

- Localized palliative external beam radiotherapy allowed

Surgery:

- Not specified

Other:

- Concurrent bisphosphonates allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan E. Bates, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

990121

NCT ID:

NCT00019812

Start Date:

August 1999

Completion Date:

February 2004

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Holy Cross HospitalFort Lauderdale, Florida  33308
Mary Babb Randolph CenterMorgantown, West Virginia  26506-9162