2006
Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC)
Green M, Pusztai L, Theriault R, Adinin R, Hofweber M, Fukushima M, Mita A, Bindra N, Hortobagyi G. Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC). Journal Of Clinical Oncology 2006, 24: 10576-10576. DOI: 10.1200/jco.2006.24.18_suppl.10576.Peer-Reviewed Original ResearchMetastatic breast cancerPhase II doseBID days 1TAS-102Dose levelsBreast cancerDay 1Grade 3 non-hematologic toxicityEvaluable metastatic breast cancerInitial starting doseNon-hematologic toxicitiesInitial dose levelAdditional dose levelsHighest dose levelEvaluation of responseMinimal alopeciaHematologic toxicityStarting doseDaily dosingStandard therapyOral combinationStudy doseClinical activityOral administrationGrade 3
2003
Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer.
Rivera E, Valero V, Arun B, Royce M, Adinin R, Hoelzer K, Walters R, Wade JL, Pusztai L, Hortobagyi GN. Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 3249-54. PMID: 12947059, DOI: 10.1200/jco.2003.03.111.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerLiposomal doxorubicinBreast cancerOverall survivalDay 1Median cumulative anthracycline doseLeft ventricular ejection fractionPhase II clinical trialCommon grade 3Cumulative anthracycline doseFrequent nonhematologic toxicitiesPrevious anthracycline exposureHand-foot syndromeMedian overall survivalMedian response durationPhase II studyFront-line therapyVentricular ejection fractionOverall response rateAdjuvant chemotherapyAnthracycline doseAssessable patientsMeasurable diseaseNeutropenic complicationsNonhematologic toxicity