2024
TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2.
Tung N, Robson M, Nanda R, Li T, Vinayak S, Shah P, Khoury K, Kimmick G, Santa-Maria C, Brufsky A, DeMeo M, Vieira J, Carey L, Wulf G, Domchek S, Krop I, Wolff A, Winer E, Garber J. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. Journal Of Clinical Oncology 2024, 42: 1021-1021. DOI: 10.1200/jco.2024.42.16_suppl.1021.Peer-Reviewed Original ResearchProgression-free survivalDuration of responseMetastatic breast cancerClinical benefit rateTriple-negative breast cancerMedian duration of responseMedian progression-free survivalMutant allele frequencyExpansion cohortHER2-negativeHER2-positiveCohort 2aNon-respondersBreast cancerEarly due to slow enrollmentMetastatic chemotherapy regimensResponse to olaparibPhase 2 studyPhase II trialKaplan-Meier methodPredictors of responseCohort of womenWilcoxon rank sum testRank sum testBRCA1m
2020
TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded).
Tung N, Robson M, Ventz S, Santa-Maria C, Marcom P, Nanda R, Shah P, Ballinger T, Yang E, Melisko M, Brufsky A, Vinayak S, Demeo M, Jenkins C, Domchek S, Wulf G, Krop I, Wolff A, Winer E, Garber J. TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded). Journal Of Clinical Oncology 2020, 38: 1002-1002. DOI: 10.1200/jco.2020.38.15_suppl.1002.Peer-Reviewed Original Research
2019
Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study
Adams S, Schmid P, Rugo HS, Winer EP, Loirat D, Awada A, Cescon DW, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O’Shaughnessy J, Loi S, Paluch-Shimon S, Tan AR, Card D, Zhao J, Karantza V, Cortés J. Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 397-404. PMID: 30475950, DOI: 10.1093/annonc/mdy517.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerDisease control ratePD-L1Positive populationPembrolizumab monotherapyMetastatic diseaseControl rateBreast cancerTreatment-related adverse eventsEnd pointManageable safety profileObjective response ratePrimary end pointSecondary end pointsProgression-free survivalSubset of patientsDurable antitumor activityDuration of responseLine of treatmentEligible patientsMedian OSMedian PFSAdverse eventsMedian duration
2017
A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB).
Anders C, Murthy R, Hamilton E, Borges V, Cameron D, Carey L, Müller V, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pivot X, Pegram M, Slamon D, Hurvitz S, Tsai M, Winer E. A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB). Journal Of Clinical Oncology 2017, 35: tps1107-tps1107. DOI: 10.1200/jco.2017.35.15_suppl.tps1107.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast carcinomaBrain metsIndependent data monitoring committeeClinical benefit ratePhase 1b studyDuration of responseIndependent central reviewPrimary study objectiveData monitoring committeeCNS progressionEGFR agentsPo bidBrain metastasesAdult patientsObjective responseOverall survivalCentral reviewStudy treatmentT-DM1CNS therapyTrastuzumab emtansineBenefit rateSelective small molecule inhibitorsBreast carcinoma
1999
Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642.
Costanza M, Weiss R, Henderson I, Norton L, Berry D, Cirrincione C, Winer E, Wood W, Frei III E, McIntyre O, Schilsky R. Safety and efficacy of using a single agent or a phase II agent before instituting standard combination chemotherapy in previously untreated metastatic breast cancer patients: report of a randomized study--Cancer and Leukemia Group B 8642. Journal Of Clinical Oncology 1999, 17: 1397-406. PMID: 10334524, DOI: 10.1200/jco.1999.17.5.1397.Peer-Reviewed Original ResearchMeSH KeywordsAdenineAdultAgedAminoglycosidesAnalysis of VarianceAnti-Bacterial AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinCyclophosphamideDoxorubicinFemaleFluorouracilFollow-Up StudiesHumansImidesIsoquinolinesMelphalanMiddle AgedNaphthalimidesNeoplasm StagingOrganophosphonatesProspective StudiesSurvival AnalysisTrimetrexateConceptsPhase II agentMetastatic breast cancer patientsStandard combination chemotherapyMetastatic breast cancerBreast cancer patientsSingle agentResponse rateCombination chemotherapyCancer patientsBreast cancerUntreated metastatic breast cancer patientsMeasurable metastatic breast cancerRandomized phase III trialPhase III trialsDuration of responseSingle-agent drugsTreatment of patientsCumulative response rateSuggestion of benefitLow response rateImmediate chemotherapyIII trialsMetastatic diseaseVisceral diseaseRandomized study