2023
Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials
Rediti M, Fernandez-Martinez A, Venet D, Rothé F, Hoadley K, Parker J, Singh B, Campbell J, Ballman K, Hillman D, Winer E, El-Abed S, Piccart M, Di Cosimo S, Symmans W, Krop I, Salgado R, Loi S, Pusztai L, Perou C, Carey L, Sotiriou C. Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials. Nature Communications 2023, 14: 7053. PMID: 37923752, PMCID: PMC10624889, DOI: 10.1038/s41467-023-42635-2.Peer-Reviewed Original ResearchConceptsEvent-free survivalHER2-positive breast cancerPathological complete responseCALGB 40601Breast cancerBreast pathological complete responseStromal tumor-infiltrating lymphocytesHormone receptor statusPhase III trialsClinical nodal statusIndependent prognostic factorTumor-infiltrating lymphocytesIdentification of patientsBreast cancer prognosisT cell receptorNeoadjuvant paclitaxelNeoadjuvant therapyIII trialsNodal statusComplete responsePrognostic factorsPrognostic scoreReceptor statusClinicopathological featuresResidual disease
2020
Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.
Fernandez-Martinez A, Krop IE, Hillman DW, Polley MY, Parker JS, Huebner L, Hoadley KA, Shepherd J, Tolaney S, Henry NL, Dang C, Harris L, Berry D, Hahn O, Hudis C, Winer E, Partridge A, Perou CM, Carey LA. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. Journal Of Clinical Oncology 2020, 38: 4184-4193. PMID: 33095682, PMCID: PMC7723687, DOI: 10.1200/jco.20.01276.Peer-Reviewed Original ResearchConceptsPathologic complete responseRelapse-free survivalHuman epidermal growth factor receptor 2HER2-positive breast cancerBetter relapse-free survivalOverall survivalCALGB 40601Breast cancerImmune signaturesGene expression signaturesDe-escalation treatment strategiesPrediction of pCREnd pointEpidermal growth factor receptor 2Shorter relapse-free survivalPrimary end pointResidual disease groupSecondary end pointsUntreated stage IIGood prognostic factorGrowth factor receptor 2Phase III trialsExpression signaturesFactor receptor 2OS benefitPALLAS: 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 Research
2019
Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance)
Sharma MR, Mehrotra S, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno‐Aspitia A, Lad TE, Velasco M, Overmoyer B, Rugo HS, Ratain MJ, Gobburu JV. Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance). The Journal Of Clinical Pharmacology 2019, 60: 444-452. PMID: 31802506, PMCID: PMC7064382, DOI: 10.1002/jcph.1559.Peer-Reviewed Original ResearchMeSH KeywordsAlbuminsAlgorithmsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsComputer SimulationDrug Administration ScheduleDrug TaperingEpothilonesFemaleHumansModels, BiologicalPaclitaxelPatient Reported Outcome MeasuresPeripheral Nervous System DiseasesPrecision MedicineConceptsDose-adjustment algorithmPatient-reported outcome dataEarly time pointsNeuropathy scoreDose adjustmentNanoparticle albuminIndividual patientsTime pointsOutcome dataChemotherapy-induced peripheral neuropathyRandomized phase III trialFirst-line chemotherapyMetastatic breast cancerPhase III trialsPatient-reported outcomesA phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma
Mayer EL, DeMichele A, Rugo HS, Miller K, Waks AG, Come SE, Mulvey T, Jeselsohn R, Overmoyer B, Guo H, Barry WT, Bartlett C, Koehler M, Winer EP, Burstein HJ. A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma. Annals Of Oncology 2019, 30: 1514-1520. PMID: 31250880, DOI: 10.1093/annonc/mdz198.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFeasibility StudiesFemaleFulvestrantHumansMiddle AgedNeoplasm InvasivenessNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneConceptsEarly breast cancerEndocrine therapyAdjuvant palbociclibBreast cancerHormone receptor-positive/HER2-negative metastatic breast cancerHER2-negative metastatic breast cancerPhase II feasibility studyProlong progression-free survivalRandomized phase III trialAdjuvant endocrine therapyPrimary end pointStage III diseasePhase II trialPhase III trialsProgression-free survivalMetastatic breast cancerYears of therapyStart of treatmentInvasive breast carcinomaEligible patientsFebrile neutropeniaPrior chemotherapyWeeks on/1II trialCumulative incidenceUpdated 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 Research
2018
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
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 2018, 29: 1541-1547. PMID: 29718092, DOI: 10.1093/annonc/mdy155.Peer-Reviewed Original ResearchMeSH KeywordsAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodFemaleFollow-Up StudiesHumansLetrozoleLiver NeoplasmsLung NeoplasmsLymphatic MetastasisNeoplasm Recurrence, LocalPrognosisPurinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateConceptsProgression-free survivalFirst-line ribociclibOverall response rateMONALEESA-2 studySecondary end pointsAdvanced breast cancerBreast cancerEnd pointOverall survivalHER2-negative advanced breast cancerKey secondary end pointMedian progression-free survivalHuman epidermal growth factor receptorExploratory biomarker analysisExploratory end pointsImproved efficacy outcomesManageable toxicity profilePrimary end pointSecond interim analysisMetastatic breast cancerPhase III trialsESR1 mRNA levelsEpidermal growth factor receptorTP53 mutation statusBiomarker analysisIdentification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study
Li D, McCall LM, Hahn OM, Hudis CA, Cohen HJ, Muss HB, Jatoi A, Lafky JM, Ballman KV, Winer EP, Tripathy D, Schneider B, Barry W, Dickler MN, Hurria A. Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Research And Treatment 2018, 171: 325-334. PMID: 29789969, PMCID: PMC6076849, DOI: 10.1007/s10549-018-4828-5.Peer-Reviewed Original ResearchConceptsHormone receptor-positive advanced breast cancerAdvanced breast cancerIncidence of gradeAdverse eventsBreast cancerPhysical functionProgression-free survival benefitMultivariable logistic regression modelAddition of bevacizumabPhase III trialsPhysical function measuresAdverse event dataFunctional Assessment MeasureIncidence of toxicityFlight of stairsLogistic regression modelsHemorrhagic eventsIII trialsSurvival benefitMedian ageThrombosis eventsRisk factorsUnivariate analysisAssessment measuresBevacizumabThe 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
Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design
Ligibel JA, Barry WT, Alfano C, Hershman DL, Irwin M, Neuhouser M, Thomson CA, Delahanty L, Frank E, Spears P, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hahn O, Hudis C, Winer EP, Wadden TA, Goodwin PJ. Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. Npj Breast Cancer 2017, 3: 37. PMID: 28948213, PMCID: PMC5608692, DOI: 10.1038/s41523-017-0040-8.Peer-Reviewed Original ResearchEarly breast cancerWeight loss interventionWeight loss programBreast cancer recurrenceBreast cancerBody weightWeight lossLoss interventionLoss programCancer recurrencePhysical activityHER-2 negative breast cancerInvasive disease-free survivalRandomized phase III trialDana-Farber Cancer InstitutePurposeful weight lossBaseline body weightCancer diagnosisDisease-free survivalExcess body weightPhase III trialsPoor prognostic factorIncidence of comorbiditiesBody mass indexWeight loss trial324TiP 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 ResearchKinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance)
Mehrotra S, Sharma MR, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno-Aspitia A, Lad TE, Valasco M, Overmoyer B, Rugo H, Ratain MJ, Gobburu JV. Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance). The AAPS Journal 2017, 19: 1411-1423. PMID: 28620884, PMCID: PMC5711539, DOI: 10.1208/s12248-017-0101-9.Peer-Reviewed Original ResearchConceptsChemotherapy-induced peripheral neuropathyProportion of patientsMetastatic breast cancerKinetic-pharmacodynamic modelIndirect response modelNab-paclitaxelDose modificationPeripheral neuropathyBreast cancerDrug effectsRandomized phase III trialLinear drug effectFirst-line chemotherapyPhase III trialsTime pointsDose-limiting toxicityLater time pointsEarly time pointsCALGB 40502Neurotoxicity ScaleIII trialsFunctional assessmentChemotherapeutic agentsPatientsCancer
2016
Phase III Trial Evaluating Letrozole As First-Line Endocrine Therapy With or Without Bevacizumab for the Treatment of Postmenopausal Women With Hormone Receptor–Positive Advanced-Stage Breast Cancer: CALGB 40503 (Alliance)
Dickler MN, Barry WT, Cirrincione CT, Ellis MJ, Moynahan ME, Innocenti F, Hurria A, Rugo HS, Lake DE, Hahn O, Schneider BP, Tripathy D, Carey LA, Winer EP, Hudis CA. Phase III Trial Evaluating Letrozole As First-Line Endocrine Therapy With or Without Bevacizumab for the Treatment of Postmenopausal Women With Hormone Receptor–Positive Advanced-Stage Breast Cancer: CALGB 40503 (Alliance). Journal Of Clinical Oncology 2016, 34: 2602-2609. PMID: 27138575, PMCID: PMC5012690, DOI: 10.1200/jco.2015.66.1595.Peer-Reviewed Original ResearchConceptsProlong progression-free survivalHormone receptor-positive metastatic breast cancerMetastatic breast cancerAddition of bevacizumabMedian PFSMeasurable diseaseOverall survivalGrade 3Breast cancerAnti-vascular endothelial growth factor therapyBevacizumab prolongs progression-free survivalDe novo metastatic breast cancerEndothelial growth factor therapyNovo metastatic breast cancerRole of bevacizumabTrial of letrozoleMedian overall survivalTreatment-related toxicityDisease-free intervalPhase III trialsProgression-free survivalGrowth factor therapyStage breast cancerHazard of progressionLine endocrine therapy
2015
Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib
Carey LA, Berry DA, Cirrincione CT, Barry WT, Pitcher BN, Harris LN, Ollila DW, Krop IE, Henry NL, Weckstein DJ, Anders CK, Singh B, Hoadley KA, Iglesia M, Cheang MC, Perou CM, Winer EP, Hudis CA. Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib. Journal Of Clinical Oncology 2015, 34: 542-549. PMID: 26527775, PMCID: PMC4980567, DOI: 10.1200/jco.2015.62.1268.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinomaEstrogen Receptor alphaFemaleGene ExpressionHumansImmunoglobulin GLapatinibMiddle AgedNeoadjuvant TherapyNeoplasm, ResidualPaclitaxelQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRNA, MessengerTrastuzumabTreatment OutcomeTumor MicroenvironmentTumor Suppressor Protein p53Young AdultConceptsPathologic complete response rateCALGB 40601Dual therapyIntrinsic subtypesHormone receptor-negative diseaseRandomized phase III trialHuman epidermal growth factor receptor 2End pointHER2-positive breast cancerEpidermal growth factor receptor 2Correlative end pointsDual HER2 blockadeHER2-positive diseaseComplete response ratePrimary end pointPhase III trialsProgression-free survivalReceptor-negative diseaseAddition of lapatinibGrowth factor receptor 2Immune cell signaturesFactor receptor 2Gene expression-based assaysMolecular featuresDual HER2Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)
Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance). Journal Of Clinical Oncology 2015, 33: 2361-2369. PMID: 26056183, PMCID: PMC4500830, DOI: 10.1200/jco.2014.59.5298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsDrug Administration ScheduleEpothilonesFemaleHumansMiddle AgedNanoparticlesNeoplasm MetastasisNeoplasm Recurrence, LocalPaclitaxelTreatment OutcomeConceptsAdvanced breast cancerProgression-free survivalNab-paclitaxelBreast cancerInterim analysisMedian progression-free survivalRandomized phase III trialEarly dose reductionSecond interim analysisFirst-line therapyPhase III trialsMetastatic breast cancerFirst interim analysisEligible patientsLine chemotherapyNonhematologic toxicityPalliative chemotherapyHazard ratioIII trialsOverall survivalPeripheral neuropathyTreatment failureExperimental armLocally RecurrentArm CPhase III trial evaluating the addition of bevacizumab to letrozole as first-line endocrine therapy for treatment of hormone-receptor positive advanced breast cancer: CALGB 40503 (Alliance).
Dickler M, Barry W, Cirrincione C, Ellis M, Moynahan M, Innocenti F, Hurria A, Rugo H, Lake D, Hahn O, Schneider B, Tripathy D, Winer E, Hudis C. Phase III trial evaluating the addition of bevacizumab to letrozole as first-line endocrine therapy for treatment of hormone-receptor positive advanced breast cancer: CALGB 40503 (Alliance). Journal Of Clinical Oncology 2015, 33: 501-501. DOI: 10.1200/jco.2015.33.15_suppl.501.Peer-Reviewed Original Research
2014
Endocrine Therapy With or Without Inhibition of Epidermal Growth Factor Receptor and Human Epidermal Growth Factor Receptor 2: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib for Postmenopausal Women With Hormone Receptor–Positive Advanced Breast Cancer—CALGB 40302 (Alliance)
Burstein HJ, Cirrincione CT, Barry WT, Chew HK, Tolaney SM, Lake DE, Ma C, Blackwell KL, Winer EP, Hudis CA. Endocrine Therapy With or Without Inhibition of Epidermal Growth Factor Receptor and Human Epidermal Growth Factor Receptor 2: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib for Postmenopausal Women With Hormone Receptor–Positive Advanced Breast Cancer—CALGB 40302 (Alliance). Journal Of Clinical Oncology 2014, 32: 3959-3966. PMID: 25348000, PMCID: PMC4251959, DOI: 10.1200/jco.2014.56.7941.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodEstradiolFemaleFulvestrantHormonesHumansLapatinibMiddle AgedPostmenopauseProportional Hazards ModelsQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTreatment OutcomeConceptsMedian progression-free survivalProgression-free survivalOverall survivalBreast cancerHormone receptor-positive advanced breast cancerHormone receptor-positive metastatic breast cancerAdvanced ER-positive breast cancerHuman epidermal growth factor receptor 2 (HER2) statusLonger median progression-free survivalEpidermal growth factor receptor 2 statusProgesterone receptor-positive tumorsHuman epidermal growth factor receptor 2ER-positive breast cancerEpidermal growth factor receptor 2Advanced breast cancerPhase III trialsGrowth factor receptor 2Metastatic breast cancerReceptor-positive tumorsHER2-positive tumorsAromatase inhibitor treatmentFactor receptor 2Epidermal growth factor receptorDifferential treatment effectsGrowth factor receptorPhase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2014, 32: 3840-3847. PMID: 25349301, DOI: 10.1200/jco.2014.55.2984.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarboplatinDeoxycytidineDisease ProgressionDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProportional Hazards ModelsRisk FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerCoprimary end pointsOverall survivalBreast cancerRandomized phase II trialEnd pointStage IV/Clinical benefit ratePhase II trialPhase III studyPhase III trialsStandard of careWarrants further evaluationLack of treatmentCarboplatin areaITT populationPrevious chemotherapyPrior chemotherapyII trialIII studyIII trialsSurvival benefitSafety profileGene expression signatures in pre- and post-therapy (Rx) specimens from CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer (BrCa).
Carey L, Barry W, Pitcher B, Hoadley K, Cheang M, Anders C, Henry N, Tolaney S, Dang C, Krop I, Harris L, Berry D, Perou C, Winer E, Hudis C. Gene expression signatures in pre- and post-therapy (Rx) specimens from CALGB 40601 (Alliance), a neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer (BrCa). Journal Of Clinical Oncology 2014, 32: 506-506. DOI: 10.1200/jco.2014.32.15_suppl.506.Peer-Reviewed Original ResearchStand Up to Cancer Phase Ib Study of Pan-Phosphoinositide-3-Kinase Inhibitor Buparlisib With Letrozole in Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer
Mayer IA, Abramson VG, Isakoff SJ, Forero A, Balko JM, Kuba MG, Sanders ME, Yap JT, Van den Abbeele AD, Li Y, Cantley LC, Winer E, Arteaga CL. Stand Up to Cancer Phase Ib Study of Pan-Phosphoinositide-3-Kinase Inhibitor Buparlisib With Letrozole in Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. Journal Of Clinical Oncology 2014, 32: 1202-1209. PMID: 24663045, PMCID: PMC3986383, DOI: 10.1200/jco.2013.54.0518.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCell Line, TumorClass I Phosphatidylinositol 3-KinasesDose-Response Relationship, DrugDrug Administration ScheduleFemaleFluorodeoxyglucose F18HumansLetrozoleMiddle AgedMorpholinesMultimodal ImagingNitrilesPhosphoinositide-3 Kinase InhibitorsPositron-Emission TomographyProtein Kinase InhibitorsRadiopharmaceuticalsReceptor, ErbB-2Receptors, EstrogenTomography, X-Ray ComputedTriazolesConceptsMaximum-tolerated dosePhase Ib studyPET/CTEndocrine therapyDisease progressionBreast cancerIb studyCommon drug-related adverse eventsDrug-related adverse eventsPIK3CA hot spot mutationsPositive breast cancer cell linesER-positive breast cancerPositron emission tomography/Human epidermal growth factor receptorBreast cancer refractoryClinical benefit rateOral reversible inhibitorPIK3CA mutation statusPhase III trialsMetastatic breast cancerRapid disease progressionEmission tomography/Different administration schedulesBreast cancer cell linesMetabolic disease progression