Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

NCT00006825 | Completed Phase 1

• 5 other identifiers: CDR0000068331P30CA016087NYU-0012ALZA-00-001-iiNCI-G00-1878
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

trastuzumab BIOLOGICAL

pegylated liposomal doxorubicin hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven breast cancer * Metastatic disease OR * Locoregional relapse following optimal adjuvant therapy and regional treatment * HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * SGOT and SGPT no greater than 3 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone * Bilirubin no greater than 1.5 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Cardiovascular: * LVEF normal by radioisotope method * No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No known sensitivity to benzyl alcohol * No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics Biologic therapy: * Not specified Chemotherapy: * No prior doxorubicin greater than 240 mg/m2 Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy to left breast or chest wall allowed Surgery: * Not specified

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

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

Study Officials

• Matthew D. Volm, MD

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: January 27, 2003
• Study Start: July 1, 2000
• Primary Completion: July 1, 2004
• Last Updated: March 28, 2011

Record last verified: 2011-03

Locations

US (1)