fulvestrant

Org: National Cancer Center Hospital East, Chiba, Japan, Samsung Medical Center, Seoul, seoul, South Korea, NEXT Oncology, San Antonio, TX, National Cancer Center Hospital, Tokyo, Japan, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea,

Abstract

First-line inavolisib/placebo + palbociclib + fulvestrant (Inavo/Pbo+Palbo+Fulv) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2‑negative locally advanced/metastatic breast cancer who relapsed during/within 12 months (mo) of adjuvant endocrine therapy completion: INAVO120 Phase III randomized trial additional analyses.

Org: Roche Products Ltd., Genentech, Roche Products Limited, German Breast Group, Centre for Haematology and Oncology Bethanien,

Abstract

Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial.

Org: Winship Cancer Institute of Emory University, IRCCS Ospedale San Raffaele, Sarah Cannon Research Institute/Tennessee Oncology, Lifespan Cancer Institute, Legorreta Cancer Center at Brown University,

Abstract

Primary results from PATRICIA cohort C (SOLTI-1303), a randomized phase II study evaluating palbociclib with trastuzumab and endocrine therapy in pretreated HER2-positive and PAM50 luminal advanced breast cancer.

Org: SOLTI Cancer Research Group, Department of Medical Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Vall d’Hebron Institute of Oncology,

Abstract

Fulvestrant with or without the cyclin-dependent kinase 7 (CDK7) inhibitor samuraciclib in advanced hormone receptor positive (HR+) breast cancer after CDK4/6 inhibition: Phase II SUMIT-BC study.

Org: Institut Català D'Oncologia, IDIBELL, L’Hospitalet, Hospital Universitario Marques de Valdecilla, Hospital Vithas Málaga,

Abstract

Tucatinib and trastuzumab for previously treated HER2−mutated metastatic breast cancer (SGNTUC−019): A phase 2 basket study.

Org: The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, Istituto Europeo di Oncologia, IRCCS and University of Milano, Aichi Cancer Center Hospital, Seoul National University Hospital,

Abstract

OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) vs standard-of-care for ER+, HER2- advanced or metastatic breast cancer patients after endocrine therapy and CDK4/6 inhibitors.

Org: Gustave Roussy Cancer Center, Vall d’Hebron University Hospital/VHIO, Vall d’Hebron Institute of Oncology, Clinical Oncology Department, IRCCS Ospedale Policlinico San Martino Genoa, Genova, Italy, IRCCS Ospedale Policlinico San Martino Genoa,

Abstract

Bireociclib plus fulvestrant for advanced HR+/HER2- breast cancer progressing after endocrine therapy: Interim analysis of a phase 3 trial (BRIGHT-2).

Org: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Harbin Medical University Cancer Hospital, Harbin, China, Department of Breast Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China, Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China, Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China,

Abstract

First-in-human study of RLY-2608, a pan-mutant and isoform selective PI3Kα inhibitor, as a single agent in patients (pts) with advanced solid tumors and in combination with fulvestrant in pts with advanced breast cancer.

Org: Vall d’Hebron University Hospital/VHIO, Vall d'Hebron Institute of Oncology, Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center, Instituto Valenciano de Oncología,

Abstract

First-in-human phase 1/2a study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 + endocrine therapy (ET): Updated safety data in patients with HR+/HER2− mBC.

Org: Centro Oncologico International,

Abstract

Phase Ib trial of tasurgratinib (E7090) with or without endocrine therapies for patients (pts) with ER+, HER2− recurrent/metastatic breast cancer (BC) after receiving a CDK4/6 inhibitor.

Org: Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR), Tokyo, Japan, Tohoku University Hospital, Miyagi, Japan, National Center for Global Health and Medicine, Tokyo, Japan, NHO Shikoku Cancer Center, Ehime, Japan, Showa University, Tokyo, Japan,

Abstract

Innovation of the first-line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for patients with HR-positive HER2-negative advanced metastatic breast cancer (JBCRG-M08; AMBER study).

Org: Osaka University Hospital, Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR), Nagoya University Hospital,

Abstract

Molecular profiling of serial liquid biopsy specimens utilizing cell free DNA (cfDNA) and circulating tumor cells (CTCs) in TBCRC041: A phase II study of alisertib in endocrine resistant metastatic breast cancer (MBC).

Org: Mayo Clinic, Dana-Farber Cancer Institute, The University of Texas MD Anderson Cancer Center, University of Michigan, Duke University Medical Center/Duke Cancer Institute,

Abstract

Implementing geriatric assessment for dose optimization of CDK 4/6 inhibitors in older breast cancer patients (IMPORTANT trial): A pragmatic randomized-controlled trial.

Org: Örebro University Hospital, Santo Stefano Hospital, General Hospital of Patras St. Andrews, Akershus University Hospital (Ahus), Papageorgiou General Hospital,

Abstract

INAVO121: Phase III study of inavolisib (INAVO) + fulvestrant (FUL) vs. alpelisib (ALP) + FUL in patients (pts) with hormone receptor-positive, HER2-negative (HR+, HER2–), PIK3CA‑mutated (mut) locally advanced or metastatic breast cancer (LA/mBC).

Org: Massachusetts General Hospital Cancer Center, Harvard Medical School, Winship Cancer Institute of Emory University, Seoul National University Hospital, IRCCS Ospedale San Raffaele,

Abstract

International phase 3 clinical trial evaluating PF-07220060 plus fulvestrant in patients with HR+/HER2− advanced/metastatic breast cancer with progression after a prior CDK4/6 inhibitor.

Org: Dana-Farber Cancer Institute, Institut Jules Bordet, Université Libre de Bruxelles, Université Libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (HUB), Centro de Pesquisa Clínica Hospital São Lucas da PUCRS,

Abstract

Plasma mutational burden in PIK3CA and TP53 independently predicts early progression in patients with HR+/HER2- metastatic breast cancer (MBC) enrolled in the GEICAM/2014-12 FLIPPER trial.

Org: Sysmex Inostics Gmbh, Sysmex Inostics, Inc., GEICAM Spanish Breast Cancer Group, Cancer Trials Ireland, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) ,

Abstract

pionERA Breast Cancer (BC): Phase III study of first-line (1L) giredestrant vs. fulvestrant, both combined with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), in patients (pts) with estrogen receptor-positive (ER+), HER2– locally advanced/metastatic BC (LA/mBC) with resistance to prior adjuvant (adj) endocrine therapy (ET).

Org: Winship Cancer Institute of Emory University, Dana-Farber Cancer Institute, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, University Hospital Erlangen, Hospital Alemán,

Abstract

Characterization of BTX-9341, a bifunctional degrader of CDK4 and CDK6 for HR+/HER2- breast cancer and glioblastoma multiforme.

Org: BioTheryX, San Diego State University Department of Biology, San Diego, CA, CanSino Biologics,

Abstract

A phase II study of fulvestrant and abemaciclib in hormone receptor positive advanced or recurrent endometrial cancer.

Org: Memorial Sloan Kettering Cancer Center, Interventional Radiology Service,

Abstract

Efficacy and genomic analysis of HER2-mutant, metastatic triple-negative breast cancer treated with neratinib alone or in combination with trastuzumab in the phase 2 SUMMIT basket trial.

Org: Memorial Sloan Kettering Cancer Center, University of Washington School of Medicine and Fred Hutchinson Cancer Center, University of Pittsburgh, Washington University School of Medicine, Kaplan Hospital,

Abstract

Open-label, randomized, multicenter, phase 3, ELAINE 3 study of the efficacy and safety of lasofoxifene plus abemaciclib for treating ER+/HER2-, locally advanced or metastatic breast cancer with an ESR1 mutation.

Org: Pangaea Oncology, Breast Oncology Institute, Sermonix Pharmaceuticals, Mayo Clinic, Medical Oncology,

Abstract

On-treatment (tx) dynamic circulating tumor DNA changes (∆ctDNA) associated with progression-free survival (PFS) and overall survival (OS) of patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA-3 (ML-3).

Org: BC Cancer - Vancouver Centre, Novartis Pharmaceuticals Corporation, Novartis Institutes for BioMedical Research, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori Regina Elena,

Abstract

Use of liquid biomarker thymidine kinase activity (TKa) to predict outcome and progression in patients with metastatic breast cancer (MBC) in the GEICAM/2014-12 FLIPPER trial.

Org: Hospital del Mar, Barcelona, Spain, CIBERONC-ISCIII, Biovica International AB, Hospital Clínico Universitario de Valencia, INCLIVA-Biomedical Research Institute,

Abstract

A phase Ib study of PI3Kα inhibitor risovalisib mesylate in combination with fulvestrant in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer.

Org: Fudan University Shanghai Cancer Center, The Second Hospital of Dalian Medical University, Harbin Medical University Cancer Hospital, Liaoning Cancer Hospital & Institute, Shenyang, China, Hunan Cancer Hospital,

Abstract

BLU-222, an investigational, oral, potent, and highly selective CDK2 inhibitor (CDK2i), as monotherapy in patients (pts) with advanced solid tumors and in combination with ribociclib (RIBO) and fulvestrant (FUL) in HR+/HER2− breast cancer (BC).

Org: Henri and Belinda Termeer Center for Targeted Therapies, Massachusetts General Hospital, Boston, MA, USA, Massachusetts General Hospital, Florida Cancer Specialists/Sarah Cannon Research Institute, University of Virginia, Charlottesville, VA, USA, Memorial Sloan Kettering Cancer Center,

Abstract

Pharmacokinetics (PK) and pharmacogenomics (PGx) of ribociclib (ribo) in Black patients with metastatic breast cancer (mBC): The LEANORA study.

Org: Georgetown University Medical Center, Washington, DC, Tufts Medical Center/Tufts University, Boston, MA, National Cancer Institute/National Institutes of Health,

Abstract

Efficacy and safety of abemaciclib in combination with endocrine therapy for HR+/HER2- advanced or metastatic breast cancer: A systematic review and meta-analysis.

Org: Services Institute of Medical Sciences,

Abstract

A phase II trial of anlotinib and fulvestrant in patients with HR-positive and HER2-negative, secondary aromatase inhibitor–resistant, metastatic breast cancer.

Org: The Third Hospital of Nanchang, Nanchang People's Hospital,

Abstract

GOG3069: Phase 2 study of alpelisib and fulvestrant for PIK3CA-mutated estrogen receptor (ER)-positive endometrioid endometrial cancers.

Org: Kettering Health Cancer Center, St. Vincent Hospital and Health Care Centers, Legacy Good Samaritan Medical Center, University of Wisconsin-Madison School of Medicine and Public Health, The University of Cincinnati Cancer,

Abstract

Clinical outcomes with alpelisib (ALP) plus fulvestrant (FUL) in patients with HR-positive (HR+)/HER2-negative (HER2-) advanced breast cancer (ABC) with PIK3CA mutations (m) in routine practice at several Russian centers.

Org: Moscow Multidisciplinary Clinical Center "Kommunarka" of the Moscow Department of Health, Moscow, Russian Federation, SBIH Moscow Multidisciplinary Clinical Center "Kommunarka" of the Moscow Department of Health, Moscow, Russian Federation, Moscow City Oncology Hospital 62, Moscow, Russian Federation, Moscow City Oncology Hospital 62, Krasnogorskiy Rayon, Russian Federation, Moscow City Clinical Oncology Hospital No. 1, Moscow, Russian Federation,

Abstract

HOPE: Harnessing olaparib, palbociclib, and endocrine therapy for BRCA1/2-associated HR+, HER2- metastatic breast cancer.

Org: Penn Medicine Abramson Cancer Center, University of Pennsylvania, Abramson Cancer Center, Hospital of the University of Pennsylvania, Memorial Sloan Kettering Cancer Center,

Abstract

Efficacy and safety of dalpiciclib, fulvestrant, and pyrotinib in HR+ HER2-low advanced breast cancer following cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors and aromatase inhibitors (AIs): A Bayesian optimal phase II trial.

Org: First Hospital of China Medical University,

Abstract

Interim safety analysis of phase IB trial of HER2 inhibitor tucatinib combined with PI3Kα inhibitor alpelisib in HER2+ PIK3CA-mutated metastatic breast cancer.

Org: University of Colorado Health Cancer Care, University of Colorado Cancer Center, Louisiana State University Health Sciences Center Shreveport, University of Wisconsin, Mount Sinai Medical Center,

Abstract

Concordance between tissue (tumor DNA) and liquid (ctDNA) biopsy next-generation sequencing (NGS) data in detection of PIK3CA, AKT1, and PTEN alterations in breast cancer: A retrospective analysis.

Org: Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, AstraZeneca, Gaithersburg, MD,

Abstract

LEONARDA-2: Lerociclib plus letrozole versus placebo plus letrozole in HR+/HER2- advanced or metastatic breast cancer.

Org: Genor Biopharma Co.,Ltd., Genor Biopharma, Genor Biopharma Co.,Ltd., Shanghai, China, Genor Biopharma Co., Ltd., Beijing, China,

Abstract

Efficacy of alpelisib (ALP) + fulvestrant (FUL) with rational use of metformin (MET) in patients with HR+/HER2- advanced breast cancer (ABC).

Org: SBIH Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM, Moscow, Russian Federation, Saint Petersburg State University, Saint Petersburg, Russian Federation, SPbGU, Saint Petersburg, Russian Federation, Department of Antitumor Drug Therapy, Clinical Oncologic Dispensary, Krasnodar, Russian Federation,

Abstract

Real-world (RW) elacestrant use patterns and therapeutic outcomes in patients (pts) with hormone receptor-positive (HR+)/HER2-negative advanced breast cancer (aBC).

Org: Guardant Health, Inc., Guardant Health, Sarah Cannon Research Institute/Tennessee Oncology, Winship Cancer Institute of Emory University, Massachusetts General Hospital Cancer Center,

Abstract

Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer.

Org: Compass Oncology/US Oncology Network, Accutar Biotechnology Inc.,

Abstract

AGITG MONARCC: A randomized phase 2 study of panitumumab monotherapy and panitumumab (pan) plus 5 fluorouracil (FU) as first-line therapy for RAS and BRAF wild type metastatic colorectal cancer—A trial by the Australasian Gastro-Intestinal Trials Group (AGITG).

Org: NHMRC Clinical Trial Centre, Shoalhaven District Memorial Hospital, Flinders Medical Centre, Australasian Gastro-Intestinal Trials Group, Sunshine Hospital,

Clinical trial

Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

Status: Active (not recruiting), Estimated PCD: 2026-10-29

Clinical trial

Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study

Status: , Estimated PCD: 2025-08-31

Clinical trial

REVERT- Breast Cancer: Phase 1b/2 Study of the Addition of STAT3 Inhibitor TTI-101 to Reverse Resistance to Palbociclib or Ribociclib Plus Aromatase Inhibitor or Fulvestrant Therapy for Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Status: Completed, Estimated PCD: 2024-04-25

Abstract

Primary outcome analysis of the phase 3 SONIA trial (BOOG 2017-03) on selecting the optimal position of cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors for patients with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC).

Org: The Netherlands Cancer Institute, Erasmus MC Cancer Institute, Netherlands Comprehensive Cancer Organisation (IKNL), Erasmus School of Health Policy & Management, Spaarne Gasthuis,

Abstract

LEONARDA-1: Phase III randomized study of lerociclib plus fulvestrant in patients with HR+, HER2- locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy.

Org: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Harbin Medical University Cancer Hospital, Harbin, China, Genor Biopharma Co., Ltd, Beijing, China, Genor Biopharma Co., Ltd., Beijing, China,

Abstract

CANKADO PRO-React eHealth support in patients with HR+ HER2- metastatic breast cancer receiving palbociclib and endocrine therapy and the affect on time to deterioration of quality of life: Primary outcome analysis of the multicenter randomized PreCycle trial.

Org: Breast Center, LMU University Hospital, Comprehensive Cancer Center Erlangen-EMN, Joint practice Wolfratshausen, Medical University of Brandenburg,

Abstract

First-line systemic treatment with palbociclib in women aged ≥70 years presenting with hormone receptor-positive advanced breast cancer: Results from the PALOMAGE program.

Org: PACAN platform, Unité d'Oncogériatrie, Department of Geriatrics, Institut Paoli-Calmettes, Marseille, France, Institut Curie, Saint Cloud, France,

Abstract

Dynamics and type of ESR1 mutations under aromatase inhibitor or fulvestrant combined with palbociclib after randomization in the PADA-1 trial.

Org: Gustave Roussy Cancer Center, CARIO - HPCA, Department of Genetics, Claudius Regaud Institute, Eugène Marquis Comprehensive Cancer Center,

Abstract

Early prediction of endocrine responsiveness in ER+/HER2 negative MBC: Pilot study with 18F-fluoroestradiol (18F-FES) CT/PET.

Org: EO Ospedali Galliera, University Hospital Munich, International Breast Cancer Center (IBCC), Vall d'Hebron Institute of Oncology, Maggiore della Carità University Hospital,

Abstract

Second-line endocrine therapy (ET) with or without palbociclib (P) maintenance in patients (pts) with hormone receptor-positive (HR[+])/human epidermal growth factor receptor 2-negative (HER2[-]) advanced breast cancer (ABC): PALMIRA trial.

Org: Kent Oncology Centre, Istituto Europeo Oncologico, Hôpital Européen Georges Pompidou, Medica Scientia Innovation Research (MEDSIR), Pangaea Oncology,

Abstract

Efficacy of oral selective estrogen receptor degraders (SERD)s in the treatment of estrogen receptor positive (ER+), HER2-negative metastatic breast cancer (MBC): A stratified analysis of the ESR1 wild type (wt) and mutant (mt) subgroups.

Org: Yong Loo Lin School of Medicine, National University of Singapore (NUS), Department of Haematology-Oncology, National University Cancer Institute, Mediclinic City Hospital,

Abstract

First-in-human phase 1 dose escalation study of the KAT6 inhibitor PF-07248144 in patients with advanced solid tumors.

Org: Next Oncology Virginia and Virginia Cancer Specialists, Sarah Cannon Research Institute/Tennessee Oncology, Tennessee Oncology, PLLC, National Cancer Center Hospital East, Kashiwa, Japan, Cedars-Sinai Cancer Institute,

Abstract

Harnessing olaparib, palbociclib, and endocrine therapy: A phase I/II trial of olaparib, palbociclib and fulvestrant in patients with BRCA mutation-associated, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (HOPE).

Org: University of Pennsylvania-Abramson Cancer Center, Philadelphia, PA, University of Pennsylvania, Hospital of the University of Pennsylvania, Univ of Pa,

Abstract

Evolving adjuvant estrogen therapy prescribing among breast oncology workforce.

Org: University of Chicago, University of Chicago Medical Center, Chicago, IL, Section of Urology, Department of Surgery, Brigham and Women's Hospital, Boston, MA, University of Chicago Department of Urology,

Abstract

Tolerability and preliminary activity of the potent, selective, oral CDK7 inhibitor SY-5609 in combination with fulvestrant in patients with advanced hormone receptor-positive (HR+), HER2- breast cancer (BC).

Org: Massachusetts General Hospital Cancer Center, Surgical Oncology, Boston, MA, Harvard Medical School, Boston, MA, Stephenson Cancer Center University of Oklahoma/Sarah Cannon Research Institute, Oklahoma City, OK,

Abstract

Exploratory biomarker analysis of acelERA breast cancer (BC): Phase II study of giredestrant vs. physician’s choice of endocrine therapy (PCET) for previously treated, estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC).

Org: Genentech, The University of Texas MD Anderson Cancer Center, Stem Cell Transplantation Rsch, Houston, TX, Massachusetts General Hospital, Harvard Medical School, Garvan Institute of Medical Research, St Vincent's Clinical School, University of New South Wales, F. Hoffmann-La Roche Ltd,

Abstract

Alpelisib + endocrine therapy in patients with PIK3CA-mutated, hormone receptor–positive, human epidermal growth factor receptor 2–negative, advanced breast cancer: Analysis of all 3 cohorts of the BYLieve study.

Org: University Hospitals, Leuven, Belgium, Medical Oncology Department, Hospital 12 de Octubre, Madrid, Spain, Institut Curie, PSL Research University, Saint-Cloud, France, Hospital Virgen del Rocio de Sevilla, Seville, Spain, Memorial Sloan Kettering Cancer Center, New York, NY, USA,

Abstract

Clinical outcomes and correlation with longitudinal circulating tumor (ct)DNA dynamics of a phase I/II study of GSK525762 combined with fulvestrant in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) advanced or metastatic breast cancer.

Org: Princess Margaret Cancer Center, University Health Network, University of Toronto, The Ottawa Hospital Cancer Center, GSK Research and Development Upper Providence, Collegeville, PA,

Abstract

A phase I trial of palbociclib (palbo) and bosutinib (bos) with fulvestrant (fulv) in patients (pts) with hormone receptor–positive, HER2-negative (HR+/HER2-) metastatic breast cancer (MBC) refractory to an aromatase inhibitor (AI) and a CDK4/6 inhibitor (CDK4/6i).

Org: Medstar Georgetown University Hospital-Lombardi Comprehensive Cancer Center, Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University, Dana-Farber Cancer Institute, AstraZeneca, Lombardi Comprehensive Cancer Center, Georgetown University,

Abstract

Endocrine therapy resistance (ETR) in hormone receptor-positive, HER2-negative metastatic breast cancer (HR+, HER2– mBC): Prevalence, biomarker characteristics, and outcomes.

Org: Dana-Farber Cancer Institute, Genentech, F. Hoffmann-La Roche Ltd, University Hospitals Seidman Cancer Center, Massachusetts General Hospital,

Abstract

First-in-human first-in-class phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC who progressed on prior CDK4/6 inhibitors and endocrine therapy.

Org: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Dana-Farber Cancer Institute, Sarah Cannon Research Institute/Tennessee Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, CT, Pfizer, Inc.,

Abstract

TACTIVE-U: Phase 1b/2 umbrella study of ARV-471, a proteolysis targeting chimera (PROTAC) estrogen receptor (ER) degrader, combined with other anticancer treatments in ER+ advanced or metastatic breast cancer.

Org: University of Texas MD Anderson Cancer Center, Sunnybrook Odette Cancer Centre, University of Toronto, The Ottawa Hospital and University of Ottawa, Washington University School of Medicine in St Louis,

Abstract

EPIK-B6: A phase 2, open-label, 2-part, multicenter study of alpelisib in combination with fulvestrant for men and postmenopausal women with PIK3CA mutation HR–positive, HER2-negative, advanced breast cancer, which progressed on/after aromatase inhibitor treatment in Japan.

Org: Novartis Pharmaceuticals Corporation, Novartis Pharma K.K.,

Abstract

Comparing the prognostic and predictive utility of serum thymidine kinase 1 and CA 15-3 in patients with hormone receptor positive metastatic breast cancer starting first-line endocrine therapy in SWOG S0226.

Org: University of Michigan, Cancer Research and Biostatistics (CRAB), Seattle, WA, Eisai, Biovica International AB, American Society of Clinical Oncology,

Abstract

The Amelia-1 study: A phase 1b/2 trial of evexomostat (SDX-7320) plus fulvestrant and alpelisib in patients with advanced breast cancer at risk for alpelisib-induced hyperglycemia.

Org: Syndevrx Inc., Syndevrx, MedAssessment, Inc, Department of Medicine, University of California Helen Diller Family Comprehensive Cancer Center,

Abstract

PLEASURABLE: Results and biomarkers analysis from the phase II study of dalpiciclib combined with pyrotinib and endocrine therapy (ET) in women with dual-receptor positive (ER+/HER2+) metastatic breast cancer (MBC).

Org: Fudan University Shanghai Cancer Center, Department of Breast Cancer, Hubei Cancer Hospital, Wuhan, China, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Department of Breast Oncology, Peking University Cancer Hospital, Harbin Medical University Cancer Hospital,

Abstract

ESR1 mutational landscape and impact of co-existing resistance variants on clinical outcomes in patients with metastatic breast cancer.

Org: Massachusetts General Hospital Cancer Center, Surgical Oncology, Boston, MA, Harvard Medical School, Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard, Cambridge, MA, Guardant Health, Inc., Department of Radiation Oncology, Sichuan Cancer Hospital & Institute, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China,

Abstract

Alliance A022102: Randomized phase III trial of mFOLFIRINOX +/- nivolumab vs. FOLFOX +/- nivolumab for first-line treatment of metastatic HER2-negative gastroesophageal adenocarcinoma (GEA).

Org: Dana-Farber Cancer Institute, Alliance Statistics and Data Management Center, Mayo Clinic, University of Nebraska Medical Center, Sanford Health,

Abstract

First-in-human phase 1/2a study of a potent and novel CDK2-selective inhibitor PF-07104091 in patients (pts) with advanced solid tumors, enriched for CDK4/6 inhibitor resistant HR+/HER2- breast cancer.

Org: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, Mission Cancer and Blood, Des Moines, IA, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, Norton Cancer Institute, Louisville, KY, Perlmutter Cancer Center, NYU Langone Health, New York, NY, Dana-Farber Cancer Institute, Boston, MA, Pfizer, Inc., La Jolla, CA, Massachusetts General Hospital, Boston, MA, START Midwest, Grand Rapids, MI,

Abstract

Phase 1/2 dose expansion study evaluating first-in-class eIF4A inhibitor zotatifin in patients with ER+ metastatic breast cancer.

Org: Memorial Sloan Kettering Cancer Center, START Midwest, Grand Rapids, MI, Valkyrie Clinical Trials, Inc, Stanford Hospital & Clinics, Virginia Cancer Specialists,

Abstract

VERITAC-2: A global, randomized phase 3 study of ARV-471, a proteolysis targeting chimera (PROTAC) estrogen receptor (ER) degrader, vs fulvestrant in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer.

Org: Institut de Cancérologie de l’Ouest Angers-Nantes, Washington University School of Medicine in St Louis, Istituto Nazionale Tumori IRCCS 'Fondazione G. Pascale', Aichi Cancer Center Hospital, UCLA Jonsson Comprehensive Cancer Center,

Abstract

evERA Breast Cancer (BC): Phase III study of giredestrant + everolimus vs exemestane + everolimus in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic BC (ER+, HER2– LA/mBC).

Org: Dana-Farber Cancer Institute, UPMC Hillman Cancer Center, University of Pittsburgh Cancer Institute, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Memorial Sloan Kettering Cancer Center,

Abstract

Randomised open-label phase II study of induction standard of care fulvestrant and CDK4/6 inhibition with addition of ipatasertib in metastatic ER+/HER2- breast cancer patients without circulating tumour (ct) DNA suppression (FAIM).

Org: The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, University Hospitals Bristol and Weston NHS Foundation Trust, The Beatson Cancer Centre, Glasgow, United Kingdom, Mount Vernon Cancer Centre, University of Manchester and The Christie NHS Foundation Trust,

Abstract

Clinical activity of camizestrant, a next-generation SERD, versus fulvestrant in patients with a detectable ESR1 mutation: Exploratory analysis of the SERENA-2 phase 2 trial.

Org: Medical Center Verum, Kyiv, Ukraine, Sarah Cannon Research Institute, Tennessee Oncology, Nashville, TN, Academician Fridon Todua Medical Center - Research Institute of Clinical Medicine, Tbilisi, Georgia, AV Medical Group, Saint Petersburg, Russian Federation, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy,

Abstract

Induction chemotherapy with nanosomal docetaxel lipid suspension (NDLS), cisplatin, and fluorouracil in patients with locally advanced head and neck squamous cell carcinoma.

Org: Jina Pharmaceuticals, Intas Pharmaceuticals Ltd.,

Abstract

Palbociclib (P) plus tamoxifen (TAM) ± goserelin in women with hormone receptor-positive (HR+)/HER2-negative (HER2−) advanced breast cancer (ABC): Primary results of NCCH1607/PATHWAY, an Asian international double-blind randomized phase 3 trial.

Org: National Cancer Center Hospital East, Chiba, Japan, National Cancer Center Hospital, Tokyo, Japan, Kanagawa Cancer Center, Kanagawa, Japan, Chiba Cancer Center, Chiba, Japan, Koo Foundation Sun Yat-sen Cancer Center, Taipei, Taiwan,

Abstract

INAVO121: Phase III study of inavolisib (INAVO) + fulvestrant (FUL) vs. alpelisib (ALP) + FUL in patients (pts) with hormone receptor-positive, HER2-negative (HR+, HER2–) PIK3CA‑mutated (mut) locally advanced or metastatic breast cancer (LA/mBC).

Org: Massachusetts General Hospital Cancer Center, Surgical Oncology, Boston, MA, Harvard Medical School, Winship Cancer Center of Emory University, Seoul National University Hospital, Cancer Research Institute,

Abstract

Interim analyses (IA) of the giredestrant (G), G + abemaciclib (A), and G + ribociclib (R) arms in MORPHEUS Breast Cancer (BC): A phase I/II study of G treatment (tx) combinations in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2– LA/mBC).

Org: Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, University of California Comprehensive Cancer Center, San Francisco, CA, Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea, Republic of (South), The Chaim Sheba Medical Center, Tel Aviv, Israel,

Abstract

A phase 3 study of gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a nonsteroidal aromatase inhibitor (VIKTORIA-1).

Org: David Geffen School of Medicine at UCLA, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, Stanford University, Stanford, CA, California Pacific Medical Center Research Institute, San Francisco, CA, Women's Health Integrated Research Center at Inova Health System, Annandale, VA, Women’s Health Integrated Research Center at Inova Health System, Department of Defense Gynecologic Cancer Center of Excellence, Annandale, VA, Stanford University Medical Center, Palo Alto, CA, Pingtung Veterans General Hospital, Pingtung, South Korea, Jonsson Comprehensive Cancer Center, Santa Monica, CA, Gustave Roussy Institute, Villejuif, France, Weill Cornell Medicine, New York, NY,

Abstract

Oral elacestrant vs standard-of-care in estrogen receptor-positive, HER2-negative (ER+/HER2-) advanced or metastatic breast cancer (mBC) without detectable ESR1 mutation (EMERALD): Subgroup analysis by prior duration of CDK4/6i plus endocrine therapy (ET).

Org: UT Health San Antonio, MD Anderson Cancer Center, Institut Curie, Saint Cloud, France, Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute, University Hospitals Seidman Cancer Center, Jean Perrin Cancer Centre,

Abstract

Circulating tumor cells (CTCs) dynamics after CDK4/6i for hormone-receptor positive (HR+) metastatic breast cancer (MBC): A biomarker analysis of the PACE randomized phase II study.

Org: CRO Aviano National Cancer Institute, IRCCS, Aviano, Italy, Dana-Farber Cancer Institute, Boston, MA, USA, Weill Cornell Medicine, New York, NY, Miami Cancer Institute, Baptist Health South Florida, Plantation, FL, Washington University School of Medicine, St. Louis, MO,

Abstract

Clinical characteristics and outcome of PIK3CA mutated hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2-), advanced breast cancer (BC) treated with cyclin-dependent kinase 4/6 inhibitors (CDK4/6i): Real world data.

Org: University Hospital Centre Zagreb, Clinical Hospital Centre Zagreb,

Abstract

Tolerability and effectiveness of fulvestrant as first-line endocrine therapy in unselected patients with advanced breast cancer (ABC): Results of a multicenter, single arm, non-interventional study.

Org: Department of Breast Cancer and Urological Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China, Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, China, Zhongshan Hospital, Fudan University, Shanghai, China, Departments of Medical Oncology, The Affiliated Tumour Hospital of Harbin Medical University, Harbin, China, Haerbin, China,

Abstract

Outcomes among Hispanic metastatic breast cancer patients treated with alpelisib and fulvestrant: Single institution retrospective study.

Org: Miami Cancer Institute - Baptist Health South Florida, Baptist Health South Florida,

Abstract

Palbociclib, trastuzumab, pyrotinib and fulvestrant in patients with brain metastasis from ER/PR positive, HER-2 positive breast cancer: Report from an interim analysis of a multicenter, prospective study in China.

Org: Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China, Sun Yat-sen University Cancer Center, Guangzhou, China, Affiliated cancer hospital of Guangxi Medical University, Guangxi, China,

Abstract

BPI-16350, a novel promising CDK4/6 inhibitor for HR+/HER2- metastatic breast cancer (MBC): Results from a phase I study.

Org: Phase I Clinical Trial Center, Fudan University Shanghai Cancer Center, Shanghai, China, Fudan University Shanghai Cancer Center, Shanghai, China, Gracell Biotechnologies, Ltd., Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy, Italy, The Third Hospital of Nanchang,

Abstract

Circulating tumor cells in patients with hormone receptor-positive, HER2-negative metastatic breast cancer receiving palbociclib with fulvestrant after progression on palbociclib with an aromatase inhibitor.

Org: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University Bloomberg School of Public Health, RPS Hematology Oncology, Allegheny General Hospital, University of Michigan,

Abstract

CDK4/6 inhibitors and cardiovascular toxicity: Real-world evidence.

Org: National and Kapodistrian University of Athens, Alexandra University Hospital,

Abstract

The real-world modeling of benefits demonstrated in major clinical trials on 2 HR+/HER2− metastatic breast cancer treatment with CDK4/6 inhibitor in the US: PALOMA-2 and MONALEESA-3.

Org: University of Virginia Health System, Duke University Medical Center / Duke Cancer Institute, University of Virginia, Charlottesville, VA, USA,

Abstract

The association between baseline patient characteristics and alpelisib-induced hyperglycaemia in patients with HR+, HER2-, PIK3CA-mutated metastatic breast cancer.

Org: Faculty of Health, Medicine and Life Sciences, Maastricht University, Institute of Oncology Ljubljana, Division of Medical Oncology, Institute of Oncology Ljubljana,

Abstract

Feasibility of treatment with another CDK4/6 inhibitor after severe ribociclib liver toxicity.

Org: EHC, Morges, Switzerland, University Hospital 12 de Octubre, Institut Curie, Saint Cloud, France, Centre GF Leclercq,

Abstract

Comparative effectiveness of palbociclib plus aromatase inhibitor versus fulvestrant alone as initial endocrine therapy for HR+/HER2- advanced breast cancer in Chinese clinical practice: A real-world study.

Org: National Cancer Center Hospital East, Kashiwa, Japan, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China, National Cancer Centre Singapore,

Abstract

Real-world efficacy of ribociclib (RIB) + aromatase inhibitor (AI)/fulvestrant (FUL), or endocrine monotherapy (ET), or chemotherapy (CT) as first-line (1L) treatment (tx) in elderly patients (pts; > 75 years) with hormone receptor–positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC): Results of fifth interim analysis (IA) from RIBANNA.

Org: Onkologie Ravensburg, University Women’s Hospital, Paracelsus Medical University, Winicker Norimed GmbH, Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China,

Product

Fulvestrant + Abemaciclib

Product

afuresertib plus fulvestrant

Product

tucidinostat, metronomic capecitabine, fulvestrant

Product

abemaciclib + fulvestrant

Abstract

https://www.abstractsonline.com/pp8/#!/10828/presentation/10500

Abstract

https://www.abstractsonline.com/pp8/#!/10828/presentation/10416