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Home > "L" Clinical Trials Conditions > Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer  Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
For Condition: inflammatory breast cancer,stage 4 breast cancer,recurrent breast cancer,stage 3B breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 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 --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/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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MariaTheodoulou, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067609; MSKCC-99054,NCI-G00-1684,LIPO-D9905
Study Start Date: August 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004925
Other Stage 3b Breast Cancer Studies:
1. Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
2. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
3. Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer
4. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
5. Vaccine Therapy With Either Neoadjuvant or Adjuvant Chemotherapy and Adjuvant Radiation Therapy in Treating Women With p53-Overexpressing Stage II or Stage III Breast Cancer
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Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
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