Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

NYU Langone Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: pegylated liposomal doxorubicin hydrochloride; Biological: trastuzumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006825

NCI-G00-1878

CDR0000068331

ALZA-00-001-ii

NYU-0012

P30CA016087 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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