Clinical Trial: Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have locally advanced , inflammatory, or metastatic breast cancer.

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

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Doxorubicin HCl Liposome and Trastuzumab (Herceptin) in Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer

Further Study Details: 

Study start: August 1999

OBJECTIVES: I. Determine the safety, especially the cardiac safety, of doxorubicin HCl liposome and trastuzumab (Herceptin) as first- or second-line therapy in women with metastatic, inflammatory, or locally advanced breast cancer.

PROTOCOL OUTLINE: Patients are stratified according to prior anthracycline therapy (yes vs no). Patients receive doxorubicin HCl liposome IV over 1 hour followed 30 minutes later by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed for at least 3 months.

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


Ages Eligible for Study:  18 Years and above



--Disease Characteristics--

  • Histologically or cytologically confirmed locally advanced, inflammatory, or metastatic adenocarcinoma of the breast that has been treated with no more than 1 prior systemic cytotoxic regimen
  • Overexpression of HER2 protein (2+ or 3+)
  • Evaluable disease
  • History of brain metastases allowed if off steroids and asymptomatic, with a 3 month or greater interval since last dose of brain irradiation, and no evidence of progression
  • Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

Biologic therapy: Prior trastuzumab (Herceptin) allowed


Endocrine therapy:

  • See Disease Characteristics
  • At least 3 weeks since prior hormonal agents
  • No concurrent hormonal therapy

Radiotherapy: See Disease Characteristics

Surgery: Not specified

Other: At least 3 weeks since other prior investigational drugs

--Patient Characteristics--

Age: 18 and over

Sex: Female

Menopausal status: Not specified

Performance status: ECOG 0-1

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

Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal: AST or ALT no greater than 4 times ULN


  • Adequate cardiac function
  • LVEF at least 50% predicted or lower limit of normal


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent medical or psychological condition that would preclude study compliance
  • No history of hypersensitivity to anthracyclines, eggs, or egg products

Location Information

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Maria Theodoulou,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067609; MSKCC-99054; NCI-G00-1684; LIPO-D9905
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000 Identifier:  NCT00004925
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005