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
2021
Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis. Annals Of Oncology 2021, 33: 321-329. PMID: 34954044, DOI: 10.1016/j.annonc.2021.12.005.Peer-Reviewed Original ResearchConceptsProgression-free survivalMetastatic breast cancerPlacebo-combination groupOverall survivalCombination groupBreast cancerHER2CLIMB trialBrain metastasesMedian durationSafety outcomesPrimary analysisFinal overall survival analysisHuman epidermal growth factor receptor 2 positive metastatic breast cancerPositive metastatic breast cancerMeaningful survival benefitMedian overall survivalPlacebo-controlled trialOverall study populationOverall survival analysisFinal OSMetastatic HER2Placebo combinationAdverse eventsLast patientPrespecified subgroupsUpdated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB).
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Zhang C, Winer E. Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2021, 39: 1043-1043. DOI: 10.1200/jco.2021.39.15_suppl.1043.Peer-Reviewed Original ResearchMetastatic breast cancerBrain metastasesOverall survivalTyrosine kinase inhibitorsBreast cancerPlacebo armAnalysis of OSOral tyrosine kinase inhibitorECOG performance statusPlacebo-controlled trialTotal study populationKaplan-Meier timeHER2CLIMB trialMeaningful prolongationMetastatic HER2Study medicationTolerability assessmentsMetastatic settingAdverse eventsDose modificationHazard ratioLast patientPerformance statusDisease progressionStudy population
2020
ABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer.
Chen W, Winer E, Ballman K, Partridge A, Carey L, Carvan M, Matyka C, Openshaw T, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy breast cancer. Journal Of Clinical Oncology 2020, 38: tps600-tps600. DOI: 10.1200/jco.2020.38.15_suppl.tps600.Peer-Reviewed Original ResearchInvasive disease-free survivalAspirin usersCardiovascular diseaseBreast cancerHER2-negative breast cancer patientsBlinded placebo-controlled trialHER2-negative breast cancerNegative breast cancer patientsRandomized phase IIIRegular aspirin usersPlacebo-controlled trialDisease-free survivalHormone receptor statusDouble-blinded fashionMonths of diagnosisBreast cancer survivorsTime of presentationBody mass indexBreast cancer patientsTherapy-Breast CancerBreast cancer survivalMultiple epidemiologic studiesNegative breast cancerAnti-tumor effectsDaily aspirin
2016
A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.
Goss P, Ingle J, Pritchard K, Robert N, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff A, Winer E, Hudis C, Stopeck A, Beck J, Kaur J, Whelan K, Tu D, Parulekar W. A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer. Journal Of Clinical Oncology 2016, 34: lba1-lba1. DOI: 10.1200/jco.2016.34.18_suppl.lba1.Peer-Reviewed Original ResearchEarly-stage breast cancerYears of tamoxifenAromatase inhibitor therapyDisease-free survivalBreast cancerAI treatmentPostmenopausal womenInhibitor therapyHormone receptor-positive early breast cancerReceptor-positive early breast cancerTwo-sided log-rank testDisease-free survival eventsPositive early breast cancerPrior adjuvant chemotherapyPlacebo-controlled trialYear overall survivalContralateral breast cancerEarly breast cancerAnnual incidence rateStage breast cancerLog-rank testStandard of careBreast cancer recurrenceAdjuvant chemotherapyAdjuvant letrozoleExtending Aromatase-Inhibitor Adjuvant Therapy to 10 Years
Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. New England Journal Of Medicine 2016, 375: 209-219. PMID: 27264120, PMCID: PMC5024713, DOI: 10.1056/nejmoa1604700.Peer-Reviewed Original ResearchConceptsContralateral breast cancerDisease-free survivalAromatase inhibitorsBreast cancerOverall survivalDisease-free survival ratesPositive early breast cancerAdjuvant aromatase inhibitorsNew-onset osteoporosisPlacebo-controlled trialPrimary end pointEarly breast cancerAnnual incidence rateTreatment of choiceBreast cancer recurrenceExtension of treatmentQuality of lifeBone painLetrozole groupAdjuvant therapyPlacebo groupPostmenopausal womenDisease recurrenceIncidence rateLower incidence