Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006825
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 28, 2011
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine

December 6, 2000
January 27, 2003
March 28, 2011
July 2000
July 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006825 on Archive Site
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Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer

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.


  • 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.

Phase 1
Phase 2
Primary Purpose: Treatment
Breast Cancer
  • Biological: trastuzumab
  • Drug: pegylated liposomal doxorubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2004   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL


  • 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


  • BUN less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN


  • LVEF normal by radioisotope method
  • No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication


  • 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


  • See Disease Characteristics

Biologic therapy:

  • Not specified


  • No prior doxorubicin greater than 240 mg/m2

Endocrine therapy:

  • Not specified


  • Prior radiotherapy to left breast or chest wall allowed


  • Not specified
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA016087 ( U.S. NIH Grant/Contract )
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New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Matthew D. Volm, MD New York University School of Medicine
New York University School of Medicine
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP