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

NCT ID: NCT00019812

Last Updated: 2012-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2004-02-29

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

trastuzumab

Intervention Type: BIOLOGICAL

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Susan E. Bates, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Mary Babb Randolph Center

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

99-C-0121

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0087

Identifier Type: -

Identifier Source: secondary_id

CDR0000067227

Identifier Type: -

Identifier Source: secondary_id

990121

Identifier Type: -

Identifier Source: org_study_id

NCT00001819

Identifier Type: -

Identifier Source: nct_alias