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Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: July 11, 2001
Last updated: March 21, 2012
Last verified: April 2003

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2.

Condition Intervention Phase
Breast Cancer Biological: trastuzumab Drug: paclitaxel Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 55
Study Start Date: August 1999
Study Completion Date: February 2004
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3


  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST and ALT no greater than 5 times ULN


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior trastuzumab


  • Not specified

Endocrine therapy:

  • At least 2 weeks since prior hormonal therapy
  • No concurrent hormone receptor therapy (e.g., tamoxifen or armidex)


  • Localized palliative external beam radiotherapy allowed


  • Not specified


  • Concurrent bisphosphonates allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00019812

United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, West Virginia
Mary Babb Randolph Center
Morgantown, West Virginia, United States, 26506-9162
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Principal Investigator: Susan E. Bates, MD National Cancer Institute (NCI)
  More Information Identifier: NCT00019812     History of Changes
Obsolete Identifiers: NCT00001819
Other Study ID Numbers: 990121
Study First Received: July 11, 2001
Last Updated: March 21, 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on June 22, 2017