2022
Long-term safety of inavolisib (GDC-0077) in an ongoing phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib and/or endocrine therapy in patients (pts) with PIK3CA-mutated, hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (BC).
Bedard P, Accordino M, Cervantes A, Gambardella V, Hamilton E, Italiano A, Juric D, Kalinsky K, Krop I, Oliveira M, Saura C, Schmid P, Turner N, Varga A, Shankar N, Schutzman J, Royer-Joo S, Martin M, Jhaveri K. Long-term safety of inavolisib (GDC-0077) in an ongoing phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib and/or endocrine therapy in patients (pts) with PIK3CA-mutated, hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (BC). Journal Of Clinical Oncology 2022, 40: 1052-1052. DOI: 10.1200/jco.2022.40.16_suppl.1052.Peer-Reviewed Original ResearchBreast cancerPO QDHormone receptor-positive/HER2-negative metastatic breast cancerFrequent treatment-related adverse eventsFrequent treatment-related grade 3HER2-negative metastatic breast cancerTreatment-related adverse eventsTreatment-related grade 3G3-4 neutropeniaPhase 1/1b studyPhase 3 doseLong-term tolerabilityNew safety signalsOverall study populationPhase 3 studyMetastatic breast cancerPreliminary antitumor activityLong-term safetyFemale ptsEndocrine therapyPrior therapyDose intensityAdverse eventsArm BMedian age
2014
Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer.
Bartley K, Wildiers H, Kim S, Krop I, Kang J, Yu R, Leung A, Trudeau C, Gonzalez-Martin A. Patient-reported outcomes (PROs) from TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in patients with pretreated HER2-positive advanced breast cancer. Journal Of Clinical Oncology 2014, 32: 153-153. DOI: 10.1200/jco.2014.32.26_suppl.153.Peer-Reviewed Original ResearchT-DM1 armNausea/vomitingEORTC QLQ-C30Patient-reported outcomesTPC armT-DM1QLQ-C30HER2-positive advanced breast cancerCox proportional hazards modelEORTC QLQ-BM22Objective response rateAdvanced breast cancerGlobal health statusPhase 3 studyPost-baseline assessmentProgression-free survivalKaplan-Meier methodCycles of treatmentProportional hazards modelImpact of treatmentDistribution of severityQuality of lifePain progressionQLQ-BM22Pain scoresRelationship between tumor biomarkers (BM) and efficacy in TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in HER2-positive advanced breast cancer (BC) previously treated with trastuzumab and lapatinib.
Kim S, Wildiers H, Krop I, Leung A, Trudeau C, Yu R, de Haas S, Gonzalez-Martin A. Relationship between tumor biomarkers (BM) and efficacy in TH3RESA, a phase 3 study of trastuzumab emtansine (T-DM1) versus treatment of physician’s choice (TPC) in HER2-positive advanced breast cancer (BC) previously treated with trastuzumab and lapatinib. Journal Of Clinical Oncology 2014, 32: 605-605. DOI: 10.1200/jco.2014.32.15_suppl.605.Peer-Reviewed Original Research
2012
LBA12 Results from Emilia, A Phase 3 Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine (X) and Lapatinib (L) in Her2-Positive Locally Advanced or Metastatic Breast Cancer (MBC)
Verma S, Miles D, Gianni L, Krop I, Welslau M, Baselga J, Pegram M, Oh D, Diéras V, Guardino E, Fang L, Lu M, Olsen S, Blackwell K. LBA12 Results from Emilia, A Phase 3 Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine (X) and Lapatinib (L) in Her2-Positive Locally Advanced or Metastatic Breast Cancer (MBC). Annals Of Oncology 2012, 23: ixe5-ixe6. DOI: 10.1016/s0923-7534(20)34362-3.Peer-Reviewed Original ResearchProgression-free survivalGenentech/RocheMetastatic breast cancerClinical benefit rateSecondary end pointsT-DM1Overall survivalEnd pointObjective responseTreatment failureBenefit ratePrior treatmentKey secondary end pointInterim overall survivalObjective response ratePrimary end pointSubgroups of ptsHormone receptor statusStudy end pointPhase 3 studyDuration of responsePotential new therapiesFinal PFS analysisCardiac AEsMBC therapy