Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI, Pharmaceutical / Industry NYU-0012 ALZA-00-001-ii, NCI-G00-1878, NCT00006825

Objectives

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

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

Matthew Volm, MD, Protocol chair(Contact information may not be current)		Ph: 212-263-6485

Registry Information
Official Title		A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer
Trial Start Date		2000-07-12
Registered in ClinicalTrials.gov		NCT00006825
Date Submitted to PDQ		2000-10-16
Information Last Verified		2004-09-03
NCI Grant/Contract Number		P30-CA16087

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