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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 27, 2003
Last Update Posted: March 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

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.


Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00019812     History of Changes
Obsolete Identifiers: NCT00001819
Other Study ID Numbers: 990121
First Submitted: July 11, 2001
First Posted: January 27, 2003
Last Update Posted: March 23, 2012
Last Verified: April 2003

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