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
2021
Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients
Paoletti C, Regan MM, Niman SM, Dolce EM, Darga EP, Liu MC, Marcom PK, Hart LL, Smith JW, Tedesco KL, Amir E, Krop IE, DeMichele AM, Goodwin PJ, Block M, Aung K, Brown ME, McCormack RT, Hayes DF. Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients. Npj Breast Cancer 2021, 7: 77. PMID: 34117261, PMCID: PMC8196036, DOI: 10.1038/s41523-021-00281-1.Peer-Reviewed Original ResearchMetastatic breast cancerProgression-free survivalER-positive metastatic breast cancerHER2-negative metastatic breast cancerWorse progression-free survivalWhole bloodTherapy indexExact testPositive metastatic breast cancer patientsMedian progression-free survivalMetastatic breast cancer patientsHuman epidermal growth factor receptorMulti-institutional clinical trialsGroup of patientsBreast cancer patientsSerial time pointsFisher's exact testTumor cell numberEpidermal growth factor receptorElevated CTCsGrowth factor receptorPrimary endpointClinical outcomesCancer patientsClinical trialsA phase I/Ib study evaluating GDC-0077 (inavolisib) + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC)
Schmid P, Bedard P, Jhaveri K, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Saura C, Turner N, Varga A, Hutchinson K, Lei G, Royer-Joo S, Thomas P, JL S, Juric D. A phase I/Ib study evaluating GDC-0077 (inavolisib) + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC). Senologie - Zeitschrift Für Mammadiagnostik Und -therapie 2021, 18: e36-e37. DOI: 10.1055/s-0041-1730220.Peer-Reviewed Original ResearchHormone receptor-positive/HER2-negative metastatic breast cancerHER2-negative metastatic breast cancerMetastatic breast cancerBreast cancerPhase IFulvestrantPatientsPalbociclibCancerPhase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells
Parsons HA, Macrae ER, Guo H, Li T, Barry WT, Tayob N, Wulf GM, Isakoff SJ, Krop IE. Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells. JCO Precision Oncology 2021, 5: 896-903. PMID: 34994617, PMCID: PMC9848583, DOI: 10.1200/po.20.00461.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-positive CTCsHER2-negative metastatic breast cancerObjective response rateBreast cancerHER2-Positive Circulating Tumor CellsHER2-positive metastatic breast cancerResponse rateMedian progression-free survivalPhase II single-arm studyProgressive metastatic breast cancerHER2-negative breast cancerAdvanced breast cancer patientsHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Tumor cellsHER2-positive diseasePrior chemotherapy regimenTumor tissue testingClinical benefit ratePrimary end pointPhase II trialProgression-free survivalGrowth factor receptor 2HER2-negative tumors
2011
PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer.
Olson E, Flores L, Najita J, Curley C, Jeong J, Murray K, Savoie J, Winer E, Krop I. PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer. Cancer Research 2011, 71: pd05-07-pd05-07. DOI: 10.1158/0008-5472.sabcs11-pd05-07.Peer-Reviewed Original ResearchHER2-positive CTCsMetastatic breast cancerHER2-negative metastatic breast cancerNegative metastatic breast cancerHER2-negative CTCsER-positive diseasePositive CTCsBreast cancerDetectable CTCsLobular histologyPositive diseaseNegative CTCsHER2 amplificationProspective validationHER2-Positive Circulating Tumor CellsHER2-negative breast cancerCEP17 ratioTumor cellsInitial screeningMajority of ptsNegative breast cancerHER2/CEP17 ratioCirculating Tumor CellsDuctal histologyBaseline characteristics