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
trastuzumab
+ pegylated liposomal doxorubicin hydrochloride
Breast Diseases+4
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps