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

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

This study is ongoing, but not recruiting participants.

Study NCT00019812. Last updated on October 18, 2008. Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Breast Cancer

Intervention ^†

Drug: paclitaxel
Drug: trastuzumab

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

August 1999

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00019812

Organization ID

CDR0000067227

Secondary IDs ^††

NCI-99-C-0121, NCI-T98-0087

Study Sponsor ^†

NCI - Center for Cancer Research-Medical Oncology

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Susan E. Bates, MD

NCI - Center for Cancer Research-Medical Oncology

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2003

First Received Date ^†

July 11, 2001

Last Updated Date

October 18, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.