2021
A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC)
Yardley DA, Young RR, Adelson KB, Silber AL, Najera JE, Daniel DB, Peacock N, Finney L, Hoekstra SJ, Shastry M, Hainsworth JD, Burris HA. A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC). Clinical Breast Cancer 2021, 22: 269-278. PMID: 34824002, DOI: 10.1016/j.clbc.2021.10.011.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerCohort 2Cohort 1Breast cancerAndrogen biosynthesisAmylase/lipaseLimited clinical activityPrior chemotherapy regimenPrior chemotherapy regimensMedian treatment durationNausea/vomitingChemotherapy regimenChemotherapy regimensPrimary endpointObjective responseOverall survivalFemale patientsAndrogen receptorClinical activityGrade 3Targetable pathwaysPatientsTherapeutic targetAR modulationTreatment duration
2011
OT3-01-01: Randomized Phase II Study of Fulvestrant Versus Fulvestrant Plus Bortezomib in Postmenopausal Women with Estrogen Receptor (ER) Positive, Aromatase-Inhibitor (AI) Resistant Metastatic Breast Cancer (MBC): New York Cancer Consortium Trial P8457.
Adelson K, Raptis G, Sparano J, Germain D. OT3-01-01: Randomized Phase II Study of Fulvestrant Versus Fulvestrant Plus Bortezomib in Postmenopausal Women with Estrogen Receptor (ER) Positive, Aromatase-Inhibitor (AI) Resistant Metastatic Breast Cancer (MBC): New York Cancer Consortium Trial P8457. Cancer Research 2011, 71: ot3-01-01-ot3-01-01. DOI: 10.1158/0008-5472.sabcs11-ot3-01-01.Peer-Reviewed Original ResearchMedian progression-free survivalMetastatic breast cancerProgression-free survivalAI therapyPostmenopausal womenMetastatic diseaseAI-resistant metastatic breast cancerResistant metastatic breast cancerAdjuvant AI therapyAI-resistant diseaseClinical benefit ratePrior chemotherapy regimenPhase II studyAdverse event ratesAddition of bortezomibHuman breast cancer cell linesEstrogen-receptor positiveRandomized phase II designsBreast cancer cell linesPhase II designUnfolded protein responseChemotherapy regimenEligible patientsMeasurable diseasePrior chemotherapy