2023
12P HER2DX in HER2-positive (HER2+) inflammatory breast cancer (IBC): A correlative analysis from a phase II clinical trial
Lynce F, Brasó-Maristany F, Waks A, Gonzalez P, Villacampa G, Torres E, Galván P, Brunet L, Anderson L, Perou C, Parker J, Vivancos A, Dilullo M, Simon S, Winer E, Overmoyer B, Mittendorf E, Prat A, Tolaney S. 12P HER2DX in HER2-positive (HER2+) inflammatory breast cancer (IBC): A correlative analysis from a phase II clinical trial. ESMO Open 2023, 8: 101236. DOI: 10.1016/j.esmoop.2023.101236.Peer-Reviewed Original ResearchDiet and physical activity interventions in Black and Latina women with breast cancer: A scoping review
Pichardo M, Sanft T, Ferrucci L, Romero-Ramos Y, Cartmel B, Harrigan M, Velazquez A, Fayanju O, Winer E, Irwin M. Diet and physical activity interventions in Black and Latina women with breast cancer: A scoping review. Frontiers In Oncology 2023, 13: 1079293. PMID: 36994212, PMCID: PMC10040823, DOI: 10.3389/fonc.2023.1079293.Peer-Reviewed Original ResearchBreast cancer survivorsPhysical activity interventionsLifestyle interventionCancer survivorsActivity interventionsLatina womenEfficacy trialsBreast cancerLatina breast cancer survivorsTrial of dietOne-year followFavorable behavioral changesBreast cancer diagnosisPrimary outcomeAvailable peer-reviewed literatureFuture trialsInformal care giversPilot trialSustained behavior changeEfficacy studiesHealthful lifestyleCare giversTrialsWeight lossCancer diagnosis
2022
p16INK4A-deficiency predicts response to combined HER2 and CDK4/6 inhibition in HER2+ breast cancer brain metastases
Ni J, Kabraji S, Xie S, Wang Y, Pan P, He X, Liu Z, Leone JP, Long HW, Brown MA, Winer EP, Dillon DAR, Lin NU, Zhao JJ. p16INK4A-deficiency predicts response to combined HER2 and CDK4/6 inhibition in HER2+ breast cancer brain metastases. Nature Communications 2022, 13: 1473. PMID: 35304445, PMCID: PMC8933392, DOI: 10.1038/s41467-022-29081-2.Peer-Reviewed Original ResearchConceptsPatient-derived xenograftsBrain metastasesMetastatic HER2-positive breast cancerBiomarker-driven clinical trialsBreast cancer brain metastasesHER2-positive breast cancerOrthotopic patient-derived xenograftsMajority of HER2Cancer brain metastasesCDK4/6 inhibitionProtein immunohistochemistryClinical trialsBreast cancerHER2Tumor suppressor p16INK4aPatientsMetastasisBCBMAbemaciclibTucatinibXenograftsImmunohistochemistryCancerCDK4/6Trials
2021
The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention
Delahanty LM, Wadden TA, Goodwin PJ, Alfano CM, Thomson CA, Irwin ML, Neuhouser ML, Crane TE, Frank E, Spears PA, Gillis BP, Hershman DL, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hudis C, Winer EP, Carey L, Partridge AH, Ligibel JA. The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Obesity 2021, 30: 28-38. PMID: 34932888, PMCID: PMC9186690, DOI: 10.1002/oby.23287.Peer-Reviewed Original ResearchConceptsWeight loss interventionWeight loss trialLifestyle interventionHealth education materialsWeight lossLoss trialPhysical activityInvasive disease-free survivalDisease-free survivalBreast cancer patientsBreast cancer diagnosisCare of thousandsEducation materialsBaseline weightCancer outcomesCancer patientsHealth coachesCancer recurrenceBreast cancerCaloric restrictionStage IITrialsCancer diagnosisInterventionWomenLBA17 Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB)
Hortobagyi G, Stemmer S, Burris H, Yap Y, Sonke G, Hart L, Campone M, Petrakova K, Winer E, Janni W, Conte P, Cameron D, André F, Arteaga C, Zarate J, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. LBA17 Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). Annals Of Oncology 2021, 32: s1290-s1291. DOI: 10.1016/j.annonc.2021.08.2090.Peer-Reviewed Original Research
2020
Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors.
Piccart MJ, Hilbers FS, Bliss JM, Caballero C, Frank ES, Renault P, Naït Kaoudjt R, Schumacher E, Spears PA, Regan MM, Gelber RD, Davidson NE, Norton L, Winer EP. Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors. Journal Of Clinical Oncology 2020, 38: 4120-4129. PMID: 33052755, DOI: 10.1200/jco.20.01382.Peer-Reviewed Original ResearchConceptsDe-escalation trialsNorth American Breast Cancer GroupBreast International GroupTreatment de-escalation trialsSystemic adjuvant therapySystemic adjuvant treatmentBreast cancer groupNoninferiority trial designAdjuvant trialsAdjuvant therapyAdjuvant treatmentCancer groupDifferent cancer typesPatient insightPatient's perspectiveEffective treatmentConsensus articleTrial designSolid tumorsField of cancerEnd pointFinancial toxicityCancer typesTrialsAdverse effectsTumour mutational burden and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: Exploratory analysis of the phase III IMpassion130 trial
Emens L, Molinero L, Adams S, Rugo H, Schneeweiss A, Diéras V, Iwata H, Barrios C, Nechaeva M, Winer E, Chang C, Chui S, Schmid P, Loi S. Tumour mutational burden and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: Exploratory analysis of the phase III IMpassion130 trial. Annals Of Oncology 2020, 31: s360-s361. DOI: 10.1016/j.annonc.2020.08.398.Peer-Reviewed Original ResearchPALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Gnant M, DeMichele A, Martin M, Burstein H, Prat A, Rubovszky G, Miller K, Pfeiler G, Winer E, Zdenkowski N, Anderson D, Nowecki Z, Loibl S, Fohler H, Metzger O, Fumagalli D, Theall K, Fesl C, Dueck A. PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2020, 31: s1145. DOI: 10.1016/j.annonc.2020.08.2240.Peer-Reviewed Original ResearchDe-escalating Breast Cancer Surgery—Where Is the Tipping Point?
Morrow M, Winer EP. De-escalating Breast Cancer Surgery—Where Is the Tipping Point? JAMA Oncology 2020, 6: 183-184. PMID: 31830209, DOI: 10.1001/jamaoncol.2019.4849.Peer-Reviewed Original Research
2019
A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC)
Bellon J, Chen Y, Rees R, Taghian A, Wong J, Punglia R, Shiloh R, Krishnan M, Andrews C, Isakoff S, Winer E, Tolaney S. A Prospective Phase I trial of Concurrent Cisplatin (CIS) and Radiation Therapy (RT) in Women with Stage II and III Triple-negative Breast Cancer (TNBC). International Journal Of Radiation Oncology • Biology • Physics 2019, 105: s43. DOI: 10.1016/j.ijrobp.2019.06.466.Peer-Reviewed Original ResearchUpdated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O’Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Annals Of Oncology 2019, 30: 1842. PMID: 31407010, PMCID: PMC6927326, DOI: 10.1093/annonc/mdz215.Peer-Reviewed Original ResearchCorrection: 18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials
Wang Y, Ayres KL, Goldman DA, Dickler MN, Bardia A, Mayer IA, Winer E, Fredrickson J, Arteaga CL, Baselga J, Manning HC, Mahmood U, Ulaner GA. Correction: 18F-Fluoroestradiol PET/CT Measurement of Estrogen Receptor Suppression during a Phase I Trial of the Novel Estrogen Receptor-Targeted Therapeutic GDC-0810: Using an Imaging Biomarker to Guide Drug Dosage in Subsequent Trials. Clinical Cancer Research 2019, 25: 1435-1435. PMID: 30770494, DOI: 10.1158/1078-0432.ccr-18-4266.Peer-Reviewed Original Research
2018
369TiP PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + Anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC)
Loibl S, Metzger O, Mandrekar S, Mundhenke C, Seiler S, Valagussa P, DeMichele A, Lim E, Tripathy D, Winer E, Huang C, Carey L, Francis P, Miller K, Goetz M, Prat A, Loi S, Krop I, Gianni L, Ciruelos E. 369TiP PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + Anti-HER2 therapy + endocrine therapy (ET) vs. anti-HER2 therapy + ET after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic breast cancer (MBC). Annals Of Oncology 2018, 29: viii121. DOI: 10.1093/annonc/mdy272.357.Peer-Reviewed Original ResearchABC trial (A011502): Randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for breast cancer.
Chen W, Winer E, Barry W, Partridge A, Carey L, Carvan M, Matyka C, Visvanathan K, Symington B, Holmes M. ABC trial (A011502): Randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for breast cancer. Journal Of Clinical Oncology 2018, 36: tps597-tps597. DOI: 10.1200/jco.2018.36.15_suppl.tps597.Peer-Reviewed Original ResearchThe Breast Cancer Weight Loss (BWEL) trial: Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early-stage breast cancer (Alliance A011401).
Ligibel J, Barry W, Alfano C, Hershman D, Irwin M, Neuhouser M, Thomson C, Delahanty L, Frank E, Spears P, Paskett E, Hopkins J, Bernstein V, Stearns V, White J, Wadden T, Goodwin P, Carey L, Partridge A, Winer E. The Breast Cancer Weight Loss (BWEL) trial: Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early-stage breast cancer (Alliance A011401). Journal Of Clinical Oncology 2018, 36: tps598-tps598. DOI: 10.1200/jco.2018.36.15_suppl.tps598.Peer-Reviewed Original Research
2017
324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancer
Metzger O, Mandrekar S, Ciruelos E, Loibl S, Valagussa P, Demichele A, Lim E, Tripathy D, Winer E, Huang C, Khoeler M, Carey L, Francis P, Miller K, Goel S, Goetz M, Prat A, Loi S, Krop I, Gianni L. 324TiP PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib + anti HER2 therapy + endocrine therapy vs anti HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive, HER2-positive metastatic breast cancer. Annals Of Oncology 2017, 28: v107-v108. DOI: 10.1093/annonc/mdx365.087.Peer-Reviewed Original Research215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer
Mayer E, Demichele A, Pfeiler G, Barry W, Metzger O, Rastogi P, Symmans F, Burstein H, Miller K, Loibl S, Schmatloch S, Goulioti T, Zardavas D, Fesl C, Koehler M, Bartlett C, Huang X, Piccart M, Winer E, Gnant M. 215TiP PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer. Annals Of Oncology 2017, 28: v66. DOI: 10.1093/annonc/mdx362.064.Peer-Reviewed Original ResearchT-DM1 — an important agent in the history of breast cancer management
Metzger-Filho O, Winer EP. T-DM1 — an important agent in the history of breast cancer management. Nature Reviews Clinical Oncology 2017, 14: 651-652. PMID: 28786416, DOI: 10.1038/nrclinonc.2017.123.Peer-Reviewed Original ResearchConceptsT-DM1HER2-positive breast cancerOverall survival benefitFavorable safety profileBreast cancer managementRelevant therapeutic targetTH3RESA trialProlonged followSurvival benefitSafety profileBreast cancerCancer managementTherapeutic targetLater linesImportant agentsPatientsHER2FollowCancerDiseaseTrialsABC trial (A011502): A randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for node positive breast cancer.
Chen W, Winer E, Barry W, Hudis C, Openshaw T, Visvanathan K, Symington B, Matyka C, Holmes M. ABC trial (A011502): A randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for node positive breast cancer. Journal Of Clinical Oncology 2017, 35: tps586-tps586. DOI: 10.1200/jco.2017.35.15_suppl.tps586.Peer-Reviewed Original ResearchAspirin usersRegular aspirin usersBreast cancer survivalMultiple epidemiologic studiesAnti-tumor activityMetastatic adenocarcinomaRandomized trialsDecreased riskCancer survivalCardiovascular diseaseMetastatic cancerEpidemiologic studiesAvailable drugsVivo evidenceAspirinMultiple pathwaysAdenocarcinomaCancerDiseaseTrials
2016
136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC
Emens L, Adams S, Loi S, Schneeweiss A, Rugo H, Winer E, Barrios C, Dieras V, de la Haba-Rodriguez J, Gianni L, Kusuma N, Chui S, Schmid P. 136TiP IMpassion130: Phase III trial comparing 1L atezolizumab with nab-paclitaxel versus placebo with nab-paclitaxel in treatment-naive patients with mTNBC. Annals Of Oncology 2016, 27 DOI: 10.1093/annonc/mdw577.019.Peer-Reviewed Original Research