Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin; Trastuzumab

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