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

NCT00019812 | Completed Phase 2

• 4 other identifiers: 99012199-C-0121NCI-T98-0087CDR0000067227
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; male breast cancer

Interventions

trastuzumab BIOLOGICAL

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Mary Babb Randolph Center

Morgantown, West Virginia, 26506-9162, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Trastuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Susan E. Bates, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 1999
• Study Completion: February 1, 2004
• Last Updated: March 23, 2012

Record last verified: 2003-04

Locations

US (3)