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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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. 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.

Official Title
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Phase I/II Study of TLC D-99 Plus Herceptin as First or Second Line Therapy for Patients With Locally Advanced Inflammatory or Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: trastuzumab
* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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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 PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 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 Cardiovascular: Adequate cardiac function LVEF at least 50% predicted or lower limit of normal Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Prior trastuzumab (Herceptin) allowed Chemotherapy: See Disease Characteristics At least 3 weeks since prior antineoplastic therapy No more than 1 prior systemic cytotoxic regimen for locally advanced, metastatic, or inflammatory breast cancer No prior anthracyclines greater than 240 mg/m2 No other concurrent antineoplastic agents No concurrent treatment with other liposomal products other than doxorubicin HCl liposome 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trastuzumab|nan|
|Drug: pegylated liposomal doxorubicin hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer