Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer.
Jhaveri K, Accordino M, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Schmid P, Saura C, Turner N, Varga A, Cheeti S, Hilz S, Hutchinson K, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman J, Juric D. Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer. Journal Of Clinical Oncology 2024, jco2400110. PMID: 39236276, DOI: 10.1200/jco.24.00110.Peer-Reviewed Original ResearchTreatment-related adverse eventsDrug-drug interactionsPreliminary antitumor activityEndocrine therapyStudy treatmentHuman epidermal growth factor receptor 2-negativeBreast cancerTreatment-related adverse event ratesLack of drug-drug interactionsConfirmed objective response rateLocally advanced/metastatic breast cancerCirculating tumor DNA analysisEffect of study treatmentPK drug-drug interactionsAntitumor activityObjective response ratePhase I/Ib studyHormone receptor-positiveProgression-free survivalAdvanced/metastatic breast cancerTumor DNA analysisBiomarkers of responseMetastatic breast cancerYears of ageReceptor-positiveETHAN: A phase II study comparing different endocrine therapies for male breast cancer.
Leone J, Ruddy K, Rashid N, Giordano S, Gupta G, Hilsenbeck S, Gucalp A, Walsh E, Sukumar J, Makhlin I, Ortiz-Perez T, Spanheimer P, Calhoun B, Wolff A, Krop I, Thompson A. ETHAN: A phase II study comparing different endocrine therapies for male breast cancer. Journal Of Clinical Oncology 2024, 42: tps632-tps632. DOI: 10.1200/jco.2024.42.16_suppl.tps632.Peer-Reviewed Original ResearchResidual cancer burdenMale breast cancerPreoperative endocrine prognostic indexTranslational Breast Cancer Research ConsortiumBreast cancerEndocrine therapyKi-67Patient-reported outcomesNeoadjuvant phaseArm BAromatase inhibitorsHuman epidermal growth factor receptor 2 (HER2)-negative breast cancerOutcome of endocrine therapyResidual cancer burden indexWindow phaseCyclin-dependent kinase 4/6Ki-67 reductionHormone receptor-positivePhase II studyInflammatory breast cancerLack of clinical trialsPhase II trialHR+/HER2- breast cancerAnti-cancer therapyStandard of care188P A health-related quality-of-life (HRQoL) analysis from DESTINY-Breast04: Trastuzumab deruxtecan (T-DXd) vs capecitabine (CAP) in patients (Pts) with hormone receptor-positive (HR+), HER2-low metastatic breast cancer (mBC)
Ueno N, Cottone F, Dunton K, Cardoso F, Yamashita T, Losada M, Niikura N, Zagouri F, Sohn J, Gombos A, Im S, Pierga J, Krop I, Hashimoto Y, Kim J, Gori S, Jacot W, Bauer R, Aguilar C, Modi S. 188P A health-related quality-of-life (HRQoL) analysis from DESTINY-Breast04: Trastuzumab deruxtecan (T-DXd) vs capecitabine (CAP) in patients (Pts) with hormone receptor-positive (HR+), HER2-low metastatic breast cancer (mBC). ESMO Open 2024, 9: 103210. DOI: 10.1016/j.esmoop.2024.103210.Peer-Reviewed Original Research