2021
A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer
Bellon JR, Chen YH, Rees R, Taghian AG, Wong JS, Punglia RS, Shiloh RY, Warren LEG, Krishnan MS, Phillips J, Pretz J, Jimenez R, Macausland S, Pashtan I, Andrews C, Isakoff SJ, Winer EP, Tolaney SM. A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2021, 111: 45-52. PMID: 33713742, DOI: 10.1016/j.ijrobp.2021.03.002.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast-conserving therapyDose-limiting toxicityBCT cohortRadiation therapyConcurrent cisplatinMastectomy cohortBreast cancerEarly-stage triple-negative breast cancerThree-year disease-free survivalPhase 1 dose-escalation trialStage IILocal-regional recurrence ratePhase 2 doseAdjuvant radiation therapyDisease-free survivalDose-escalation trialPhase 1b trialDose of cisplatinHER2-positive tumorsEligible patientsUrinary infectionAdditional patientsDose escalationRecurrence rate
2013
Long‐term cardiac safety and outcomes of dose‐dense doxorubicin and cyclophosphamide followed by paclitaxel and trastuzumab with and without lapatinib in patients with early breast cancer
Morris PG, Iyengar NM, Patil S, Chen C, Abbruzzi A, Lehman R, Steingart R, Oeffinger KC, Lin N, Moy B, Come SE, Winer EP, Norton L, Hudis CA, Dang CT. Long‐term cardiac safety and outcomes of dose‐dense doxorubicin and cyclophosphamide followed by paclitaxel and trastuzumab with and without lapatinib in patients with early breast cancer. Cancer 2013, 119: 3943-3951. PMID: 24037735, DOI: 10.1002/cncr.28284.Peer-Reviewed Original ResearchConceptsDistant disease-free survivalCongestive heart failureEarly breast cancerHuman epidermal growth factor receptor 2Breast cancerTrial ALong-term cardiac safetyEpidermal growth factor receptor 2Dose-dense doxorubicinDose-dense chemotherapyAnti-HER2 therapyDisease-free survivalPhase 2 trialGrowth factor receptor 2Long-term incidenceFactor receptor 2Previous hypertensionCumulative incidenceHeart failureAdditional patientsCardiac safetyLower riskReceptor 2PatientsTrial B.
2011
P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer.
Isakoff S, Overmoyer B, Tung N, Gelman R, Habin K, Qian J, Giranda V, Shepherd S, Garber J, Ellisen L, Winer E, Goss P. P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer. Cancer Research 2011, 71: p3-16-05-p3-16-05. DOI: 10.1158/0008-5472.sabcs11-p3-16-05.Peer-Reviewed Original ResearchMetastatic breast cancerClinical benefit ratePrior platinum treatmentExpansion cohortResponse rateBenefit ratePlatinum treatmentPo bidPrior platinumMedian PFSAdditional patientsOriginal cohortBreast cancerCommon grade 3/4 toxicitiesSingle-arm phase II trialArm phase II trialBreast cancer xenograft modelPARP inhibitor veliparibPrior adjuvant chemotherapySafety of temozolomideGrade 3/4 toxicitiesPhase II studyFirst-line therapyPhase II trialOverall response rate