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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00019812
First received: July 11, 2001
Last updated: March 21, 2012
Last verified: April 2003
History of Changes
  Purpose

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:

U.S. FDA Resources

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019812

Locations
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)
Investigators
Principal Investigator: Susan E. Bates, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00019812     History of Changes
Obsolete Identifiers: NCT00001819
Other Study ID Numbers: 990121, 99-C-0121, NCI-T98-0087, CDR0000067227
Study First Received: July 11, 2001
Last Updated: March 21, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013