2022
A randomized phase III, double-blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast cancer (A011502): The Aspirin after Breast Cancer (ABC) Trial
Chen W, Ballman K, Winer E, Openshaw T, Hahn O, Briccetti F, Irvin W, Pohlmann P, Carey L, Partridge A, Weiss A, McCall L, Matyka C, Carvan M, Holmes M. A randomized phase III, double-blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast cancer (A011502): The Aspirin after Breast Cancer (ABC) Trial. Journal Of Clinical Oncology 2022, 40: 360922-360922. DOI: 10.1200/jco.2022.40.36_suppl.360922.Peer-Reviewed Original ResearchInvasive disease-free survivalHER2-negative breast cancerStratified hazard ratioDisease-free survivalHazard ratioBreast cancerIDFS eventsAspirin usersCardiovascular diseaseGrade 3/4 adverse eventsAspirin/non-steroidal anti-inflammatory drugsNon-steroidal anti-inflammatory drugsAdjuvant aspirin therapyRandomized phase IIIRegular aspirin usersPlacebo-controlled trialDouble-blinded fashionBreast cancer survivorsBody mass indexBreast cancer trialsBreast cancer survivalBreast cancer recurrenceMultiple epidemiologic studiesAnti-inflammatory drugsAnti-tumor effects
2019
A phase II study of cabozantinib alone or in combination with trastuzumab in breast cancer patients with brain metastases
Leone JP, Duda DG, Hu J, Barry WT, Trippa L, Gerstner ER, Jain RK, Tan S, Lawler E, Winer EP, Lin NU, Tolaney SM. A phase II study of cabozantinib alone or in combination with trastuzumab in breast cancer patients with brain metastases. Breast Cancer Research And Treatment 2019, 179: 113-123. PMID: 31541381, DOI: 10.1007/s10549-019-05445-z.Peer-Reviewed Original ResearchConceptsBreast cancer brain metastasesObjective response rateCNS objective response ratePhase II studyCohort 2Cohort 1BCBM patientsBrain metastasesII studyCohort 3Central nervous system (CNS) objective response rateMost common grade 3/4 adverse eventsCommon grade 3/4 adverse eventsSingle-arm phase II studyGrade 3/4 adverse eventsSecondary objectiveTolerability of cabozantinibWhole brain radiationCancer brain metastasesProgression-free survivalBreast cancer patientsTumor blood volumeCabozantinib 60RECIST 1.1STie-2
2016
Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study
Tolaney SM, Nechushtan H, Ron IG, Schöffski P, Awada A, Yasenchak CA, Laird AD, O’Keeffe B, Shapiro GI, Winer EP. Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study. Breast Cancer Research And Treatment 2016, 160: 305-312. PMID: 27714541, PMCID: PMC5065609, DOI: 10.1007/s10549-016-4001-y.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalOverall survivalStable diseaseMBC patientsWeek 12Common grade 3/4 adverse eventsOverall median progression-free survivalGrade 3/4 adverse eventsMedian progression-free survivalSolid Tumors version 1.0Metastatic breast cancer patientsOral tyrosine kinase inhibitorResultsForty-five patientsDisease control rateMedian overall survivalPalmar-plantar erythrodysesthesiaResponse Evaluation CriteriaMetastatic breast carcinomaBreast cancer patientsTyrosine kinase inhibitorsCabozantinib monotherapyDiscontinuation studyPrimary endpointRespiratory failure
2014
TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases
Anders C, Deal AM, Abramson V, Liu MC, Storniolo AM, Carpenter JT, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin NU, Kelly Marcom P, Van Poznak C, Stearns V, Melisko M, Smith JK, Karginova O, Parker J, Berg J, Winer EP, Peterman A, Prat A, Perou CM, Wolff AC, Carey LA. TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases. Breast Cancer Research And Treatment 2014, 146: 557-566. PMID: 25001612, PMCID: PMC4112043, DOI: 10.1007/s10549-014-3039-y.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBrain NeoplasmsCamptothecinDrug-Related Side Effects and Adverse ReactionsFemaleHumansIrinotecanMiddle AgedNeoplasm StagingReceptor, ErbB-2Survival AnalysisTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor AConceptsTriple-negative breast cancerClinical benefit rateBrain metastasesOverall survivalResponse rateTriple negative breast cancer brain metastasisCommon grade 3/4 adverse eventsAdvanced triple-negative breast cancerGrade 3/4 adverse eventsIntracranial clinical benefit rateBreast cancer brain metastasesGrade 3/4 diarrheaIntracranial response ratesProgressive brain metastasesMedian overall survivalPhase II studyPrimary end pointCancer brain metastasesHalf of patientsHealth-related qualityBRCA germline mutationsTreatment-refractory diseaseBlood-brain barrierNegative breast cancerGermline BRCA1/2 status
2013
TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets).
Anders C, Deal A, Abramson V, Liu M, Storniolo A, Carpenter J, Puhalla S, Nanda R, Melhem-Bertrandt A, Lin N, Marcom P, Van Poznak C, Stearns V, Melisko M, Smith J, Karginova O, Winer E, Perou C, Wolff A, Carey L. TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) central nervous system (CNS) metastases (mets). Journal Of Clinical Oncology 2013, 31: 515-515. DOI: 10.1200/jco.2013.31.15_suppl.515.Peer-Reviewed Original ResearchQuality of lifeBlood-brain barrierResponse rateCommon grade 3/4 adverse eventsCentral nervous system metastasesGrade 3/4 adverse eventsClinical benefit rateNervous system metastasesPhase II studyTumor response rateKaplan-Meier methodWhole brain RTHalf of womenBetter response rateSmall molecule anti-cancer agentTopoisomerase I inhibitorAdvanced TNBCCorrelative endpointsEligible ptsGermline BRCA1/2Measurable lesionsMedian TTPRadiation-naïveAnti-cancer agentsPrimary endpoint