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 liposomaldoxorubicin and trastuzumab in treating women who have advanced breast cancer.

Condition	Treatment or Intervention	Phase
stage IV breast cancer recurrent breast cancer	Drug: doxorubicin HCl liposome  Drug: trastuzumab  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: monoclonal antibody therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES:

• Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer.
• Determine the efficacy of this regimen in these patients.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

New York
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Matthew D. Volm, MD,  Study Chair,  Kaplan Cancer Center   

Study ID Numbers:  CDR0000068331; NYU-0012; ALZA-00-001-ii; NCI-G00-1878
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  December 6, 2000
ClinicalTrials.gov Identifier:  NCT00006825
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08