Ongoing Trials Poster Session 2 – Thursday, December 9, 2021: 5:00 pm – 6:30 pm CT
   
  New drugs and therapeutic strategies
OT2-01-01 Phase 1 study of ST101, a first-in-class peptide antagonist of CCAAT/enhancer-binding protein β (C/EBPβ), in patients with advanced solid tumors, with a phase 2 expansion in patients with hormone receptor positive breast cancer (HR+ BC)
Bexon AS, Arkenau H-T, Evans J, Falchook GS, Symeonides SN, McKean MA, Fontana E, Bupath M, McLaren A, Chandana S, Ding T, Lim EA, Rotolo J, Capiaux G, Michel R, Kaesshaefer S, Lakhani NJ. Sapience Therapeutics Inc., Harrison, NY; Sarah Cannon Research Institute and University College London, London, United Kingdom; University of Glasgow, Beatson West of Scotland Cancer Center, Glasgow, United Kingdom; Sarah Cannon Research Institute, Denver, CO; Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, United Kingdom; The University of Texas MD Anderson Cancer Center, Houston, TX; Sarah Cannon Research Institute UK, London, United Kingdom; Sarah Cannon Research Institute at HealthONE, Denver, CO; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; START Midwest, Grand Rapids, MI; Columbia University-Herbert Irving Comprehensive Cancer Center, New York, NY.
OT2-01-02 First in human phase 1 dose escalation and expansion study of the safety and pharmacokinetics of the oral CDK7 inhibitor XL102 as a single-agent and in combination therapy in patients with inoperable locally advanced or metastatic solid tumors, including breast cancer
Patnaik A, Barve M, Bhave M, Subbiah V, Atwal S, Sharma K, Scheffold C, Wetmore C, Shapiro G. START Center for Cancer Care, San Antonio, TX; Mary Crowley Cancer Research Centers, Dallas, TX; Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA; Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX; Exelixis, Inc., Alameda, CA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
OT2-01-03 Trial in progress: Phase 2 study of intratumoral plasmid interleukin-12 (tavokinogene telseplasmid; TAVO™) plus electroporation in combination with pembrolizumab with or without chemotherapy in patients with inoperable locally advanced or metastatic triple-negative breast cancer (KEYNOTE-890/OMS-I141)
Telli M, Devitt B, Cuff K, Vinayak S, Nanda R, Montero AJ, Hui R, Canton DA, Twitty C, Xie S, Bannavong D, O'Keeffe B, Aung S, Joshi R. Standford University School of Medicine, Stanford, CA; Eastern Health Clinical School, Monash University, Box Hill, VIC, Australia; Princess Alexandra Hospital, Woolloongabba, QLD, Australia; University of Washington, Fred Hutchinson Cancer Center, Seattle Cancer Care Alliance, Seattle, WA; University of Chicago, Chicago, IL; University Hospitals Seidman Cancer Center Case Western Reserve University, Cleveland, OH; Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney, Australia; OncoSec Medical Incorporated, San Diego, CA; Adelaide Oncology and Haematology, Adelaide, SA, Australia.
   
  Patient management - adjuvant endocrine therapy
OT2-02-01 Utilization of patient reported outcomes generated by electronic medical record and smart pill bottles with follow up telehealth encounters to improve adherence to adjuvant endocrine therapy in breast cancer patients
Kunwor R, Strickland K, Galal AS, Silver D, Jaslow R, Murphy R, Sowers N, Hansch K, Fellin F, Zibelli A, Scarpaci A, Lopez A, Abu-Khalaf M. Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA.
   
  Patient management - chemotherapy response evaluation
OT2-03-01 RNA disruption assay (RDA) - Breast cancer response evaluation for individualized therapy (brevity/brevity-02)
Trudeau M, Tio J, Ademuyiwa F, Petit T, Hennessy B, Cazzaniga M, Generali D. Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Universitatsklinikum Munster, Munster, Germany; Siteman Cancer Center, St Louis, MO; Institut de Cancerologie de Strasbourg, Strasbourg, France; Beaumont Hospital, Dublin, Ireland; Hospital Oncologico, ASST di Monza, Monza, Italy.
   
  Patient management - circulating tumor guided adaptive therapy
OT2-04-01 Circulating tumor DNA-guided adaptive therapy escalation in ER+ MBC: A phase 1b study with letrozole, palbociclib and onapristone ER
Drago JZ, Walsh EM, Gonen M, Berger MF, Robson ME, Chandarlapaty S, Razavi P, Jhaveri K. Memorial Sloan Kettering Cancer Center, New York, NY.
   
  Patient management - HER2+
OT2-05-01 The HER2-RADiCAL study (Response ADaptive CAre pLan) - Tailoring treatment for HER2 positive early breast cancer
Macpherson I, McIntosh S, Kilburn L, Tovey H, Kernaghan S, Goddard K, Bhattacharya I, Boyd C, Coles C, Kirwan C, Mackenzie M, O’Brien C, Ring A, Snowdon C, Stobart H, Wheatley D, Wardley A, Shaaban A, Hall P, Cameron D, Bliss J. University of Glasgow, Glasgow, United Kingdom; The Queen's University of Belfast, Belfast, United Kingdom; Clinical Trials and Statistics Unit at The Institute of Cancer Research, London, United Kingdom; Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom; Belfast Health and Social Care Trust, Belfast, United Kingdom; Department of Oncology, University of Cambridge, Cambridge, United Kingdom; The Christie NHS Foundation Trust, Manchester, United Kingdom; Independent Cancer Patients' Voice, London, United Kingdom; The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom; Royal Cornwall Hospitals NHS Trust, Truro, United Kingdom; Outreach Research & Innovation Group and AstraZeneca, Manchester, United Kingdom; University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom; The University of Edinburgh, Edinburgh, United Kingdom.
   
  Patient management - molecular profiling
OT2-06-01 Solti-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain
Casas A, Ciruelos E, Oliveira M, Saura C, Bellet M, Pernas S, Gavilá J, Muñoz M, Vidal M, González-Farré B, Cejalvo JM, López R, Vivancos A, Malumbres M, Bofill JS, Blancas I, Alba E, Boni V, De la Cruz S, Galve E, Perelló A, Margelí M, Soler M, Olivera-Salguero R, Masanas H, Olmos R, Forns M, Fernández Pascual P, Seguí E, Pascual T, Prat A. Fundación Actitud Frente al Cáncer, Sevilla, Spain; SOLTI Breast Cancer Research Group / Hospital 12 de Octubre, Madrid, Barcelona / Madrid, Spain; SOLTI Breast Cancer Research Group / Vall d' Hebron University Hospital, Barcelona / Vall d’Hebron Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group / Institut Catala d’ Oncologia-L’Hospitalet, L’Hospitalet de Llobregat, L'Hospitalet de Llobregat, Spain; SOLTI Breast Cancer Research Group / Instituto Valenciano de Oncología, Barcelona / Valencia, Spain; SOLTI Breast Cancer Research Group / Hospital Clinic de Barcelona, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain; Hospital Clinic de Barcelona, Barcelona, Barcelona, Spain; Hospital Clínico Universitario de Valencia, Valenciamit, Spain; Complejo Universitario Santiago de Compostela, Santiago de Compostela, Spain; Vall d’Hebron Institute of Oncology, Barcelona, Spain; Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Hospital Virgen del Rocío, Sevilla, Sevilla, Spain; Hospital Universitario San Cecilio de Granada, Granada, Spain; Hospital Clínico Universitario Virgen de la Victoria, Málaga, Málaga, Spain; Centro Integral Oncológico Clara Campal, Madrid, Madrid, Spain; Complejo Hospitalario de Navarra, Pamplona, Pamplona, Spain; Hospital de Basurto, Bilbao, Bilbao, Spain; Hospital Universitari Son Espases, Palma de Mallorca, Palma de Mallorca, Spain; ICO-Badalona, BARGO Research Grup , Badalona, Badalona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Barcelona, Spain; Asociación Cáncer de Mama Metastásico, Madrid, Spain; SOLTI Breast Cancer Research Group / Hospital Clinic de Barcelona, Barcelona, Barcelona, Spain.
   
  Prognosis - genomic signatures
OT2-07-01 The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early-stage breast cancer
Ma CX, Maganini R, Whitworth P, Crozier JA, O'Shaughnessy J, Diab S, Lesnikoski B-A, Lee J, D'Abreo N, Mavromatis BH, Kelemen P, Pronin D, Abebe H, Bolner ML, Finn C, Blumencranz L, Audeh W, FLEX Investigators Group. Washington University School of Medicine, St. Louis, MO; AMITA Health, Barlett, IL; Nashville Breast Cancer, Nashville, TN; Baptist MD Anderson Cancer Center, Jacksonville, FL; Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX; Rocky Mountain Cancer Center-Aurora, Aurora, CO; Breast Specialists of South Florida, Atlantis, FL; NYU Langone Health, Mineola, NY; UPMC Western Maryland, Cumberland, MD; Northwell Health Physician Partners, Dobbs Ferry, NY; Agendia N.V., Amsterdam, Netherlands; Agendia, Inc., Irvine, CA.
   
  Racial and ethnic disparities
OT2-08-01 Racial and ethnic groups have different clustering of common cancer genes
Beitsch P, Wernecke C, Bontempo K, Bentley B, Graham M, Whitworth P Patel R. Dallas Surgical, Dallas, TX; Medneon, Cupertino, CA; Nashville Breast Center, Nashville, TN; Good Samaritan Hospital, Los Gatos, CA.
OT2-08-02 Racial and ethnic groups have different clustering of variants of uncertain significance
Beitsch P, Wernecke C, Bontempo K, Bentley B, Graham M, Whitworth P, Patel R. Dallas Surgical, Dallas, TX; Medneon, Cupertino, CA; Nashville Breast Center, Nashville, TN; Good Samaritan Hospital, Los Gatos, CA.
   
  Radiation therapy - brain mets
OT2-09-01 Phase I/II study of stereotactic radiation and abemaciclib in the management of hormone receptor positive HER2 negative breast cancer brain metastases
Ahmed KA, Kim Y, DeJesus M, Beyer SJ, Williams NO, Palmer J, Woodhouse KD, Murthy RK, Li J, Armaghani AJ, Arrington JA, Costa RL, Czerniecki BJ, Etame AB, Forsyth PA, Khong HT, Oliver DE, Rosa M, Sahebjam S, Soliman HH, Soyano AE, Vogelbaum MA, Yu M, Han HS. Moffitt Cancer Center, Tampa, FL; Ohio State University, Columbus, OH; MD Anderson Cancer Center, Houston, TX.
   
  Screening
OT2-10-01 Withdrawn
OT2-10-02 Mypebs: An international randomized study comparing personalized, risk-stratified to standard breast cancer screening in women aged 40-70
Delaloge S, Giorgi Rossi P, Guindy M, Gilbert F, Burrion J-B, Balleyguier C, Roman Exposito M, Giordano L, De Koning H, de Montgolfier S, Ragusa S, Drubay D, Rouge-Bugat M-E, Evans GD, Keatley D, Blanche H, Boland A, Gauthier E, Dubois d'Aische A, Vissac-Sabatier C, Couch D, Baron C, Deleuze J-F, Pharoah P Michiels S. Gustave Roussy, Villejuif, France; AUSL Reggio Emilia, Reggio Emilia, Italy; Assuta, Tel Aviv, Israel; University of Cambridge, Cambridge, United Kingdom; Institut Jules Bordet, Bruxelles, Belgium; Hospital del Mar, Barcelona, Spain; CPO Piemonte, Torino, Italy; Erasmus, Rotterdam, Netherlands; Paris XIII University, Créteil, France; Predilife, Villejuif, France; Université Paul sabatier Toulouse III, Toulouse, France; University of Manchester, Manchester, United Kingdom; Independent Patients Voices, London, United Kingdom; CEPH, Paris, France; CNRGH, Evry, France; Eonix, Brussels, Belgium; Unicancer, Le Kremlin Bicetre, France.
   
  SERDs
OT2-11-01 EMBER-3: A randomized phase 3 study of LY3484356, a novel, oral selective estrogen receptor degrader vs investigator’s choice of endocrine therapy of either fulvestrant or exemestane, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer previously treated with endocrine-based therapy
Jhaveri K, Harbeck N, Aftimos P, Kim S-B, Pivot X, Saura C, Curigliano G, Casalnuovo M, Wang XA, Young SRL, Smyth L, O'Shaughnessy J. Memorial Sloan Kettering Cancer Center, New York, NY; Department of Obstetrics and Gynecology, Breast Center, LMU University Hospital, Munich, Germany; Clinical Trials Conduct Unit, Institut Jules Bordet - Université Libre de Bruxelles, Brussels, Belgium Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institut Régional Du Cancer, Strasbourg, France; Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; Istituto Europeo di Oncologia, IRCCS, and University of Milano, Milano, Italy; Fundación Cenit Para La Investigación En Neurociencias, Buenos Aires, Argentina; Loxo Oncology at Lilly, Indianapolis, IN; Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX.
OT2-11-02 Ameera-1 Arm 4: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with everolimus in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer
Campone M, Neven P, Petrakova K, Braga S, Celanovic M, Cohen P, Gosselin A, Cartot-Cotton S, Pelekanou V, Boni V. Institut de Cancérologie de l'Ouest, René Gauducheau, St Herblain, France; Universitair Ziekenhuis Leuven, Leuven, Belgium; Masarykův Onkologický Ustav, Brno, Czech Republic; Instituto CUF de Oncologia, Lisbon, Portugal; Sanofi, Cambridge, MA; Sanofi, Paris, France; START Madrid-CIOCC, Centro Oncológico Clara Campal, HM Hospitales Sanchinarro, Madrid, Spain.
OT2-11-03 AMEERA-1 : Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with alpelisib in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2-)PIK3CA-mutated advanced breast cancer
Campone M, Bardia A, Kabos P, Chandarlapaty S, Neven P, Boni V, Lord S, Cartot-Cotton S, Celanovic M, Gosselin A, Pelekanou V, Linden HM. Institut de Cancérologie de l'Ouest, René Gauducheau, St Herblain, France; Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; University of Colorado, Aurora, CO; Memorial Sloan Kettering Cancer Center, New York, NY; Universitair Ziekenhuis Leuven, Leuven, Belgium; START Madrid-CIOCC, Centro Oncológico Clara Campal, HM Hospitales Sanchinarro, Madrid, Spain; University of Oxford, Oxford, United Kingdom; Sanofi, Paris, France; Sanofi, Cambridge, MA; University of Washington Medical Center, Seattle Cancer Care Alliance, Seattle, WA.
OT2-11-04 Ameera-1 Arm 5: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with abemaciclib in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer
Campone M, Chandarlapaty S, Bardia A, Neven P, Petrakova K, Kabos P, Boni V, Braga S, Celanovic M, Cohen P, Gosselin A, Cartot-Cotton S, Pelekanou V, Linden H. Institut de Cancérologie de l'Ouest, René Gauducheau, St Herblain, France; Memorial Sloan Kettering Cancer Center, New York, NY; Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Universitair Ziekenhuis Leuven, Leuven, Belgium; Masarykův Onkologický Ustav, Brno, Czech Republic; University of Colorado, Aurora, CO; START Madrid-CIOCC, Centro Oncológico Clara Campal, HM Hospitales Sanchinarro, Madrid, Spain; Instituto CUF de Oncologia, Lisbon, Portugal; Sanofi, Cambridge, MA; Sanofi, Paris, France; University of Washington Medical Center, Seattle Cancer Care Alliance, Seattle, WA.
OT2-11-05 SERENA-6: A Phase III study to assess the efficacy and safety of AZD9833 (camizestrant) compared with aromatase inhibitors when given in combination with palbociclib or abemaciclib in patients with HR+/HER2- metastatic breast cancer with detectable ESR1m who have not experienced disease progression on first-line therapy
Bidard F-C, Kalinsky K, Cristofanilli M, Bianchini G, Chia SKL, Janni W, Ma CX, Mayer EL, Park YH, Fox S, Liu X, Walding A, Huang Bartlett C, Turner NC. Institut Curie, Paris, France; Emory University, Atlanta, GA; Northwestern University Feinberg School of Medicine, Chicago, IL; IRCCS Ospedale San Raffaele, Milan, Italy; British Columbia Cancer Agency, Vancouver, BC, Canada; University Hospital Ulm, Ulm, Germany; Washington University School of Medicine, St Louis, MO; Dana-Farber Cancer Institute, Boston, MA; Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; AstraZeneca, Cambridge, United Kingdom; AstraZeneca, Gaithersburg, MD; Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom.
OT2-11-06 SERENA-4: A Phase III comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive/HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease
André F, Im S-A, Neven P, Baird RD, Ettl J, Goetz MP, Hamilton E, Iwata H, Jiang Z, Joy AA, Haddad V, Walding A, Selvi Miralles M, Huang Bartlett C, Llombart-Cussac A. Institute Gustave Roussy, Villejuif, France; Seoul National University Hospital, Seoul, Republic of Korea; Universitair Ziekenhuis, Leuven, Belgium; Cancer Research UK Cambridge Centre, Cambridge, United Kingdom; Technical University Munich, Klinikum rechts der Isar, Munich, Germany; Mayo Clinic, Rochester, MN; Sarah Cannon Research Institute, Nashville, TN; Aichi Cancer Center Hospital, Nagoya, Japan; The Fifth Medical Center of the Chinese PLA General Hospital, Beijing, China; University of Alberta, Edmonton, AB, Canada; AstraZeneca, Cambridge, United Kingdom; AstraZeneca, Gaithersburg, MD; Universidad Católica de Valencia, Valencia, Spain.
OT2-11-07 Solti-1905. Elacestrant in preoperative setting, a window of opportunity study (ELIPSE trial)
Vidal M, Muñoz M, Margeli M, González X, Amillano K, Sánchez-Bayona R, Salvador F, Pascual T, Prat A, Bellet M. SOLTI Breast Cancer Research Group/Hospital Clinic de Barcelona/August Pi i Sunyer Biomedical Research Institute (IDIBAPS)/University of Barcelona, Barcelona, Spain; SOLTI Breast Cancer Research Group/Hospital Clinic de Barcelona/August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; ICO Badalona, Barcelona, Spain; Hospital General de Cataluña, Barcelona, Spain; Hospital Sant Joan de Reus, Barcelona, Spain; Hospital 12 de Octubre, Barcelona, Spain; SOLTI, Barcelona, Spain; Vall d’Hebron University Hospital/Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain.
OT2-11-08 AMEERA-5 : A randomized, double-blind phase 3 study of amcenestrant (SAR439859) + palbociclib versus letrozole + palbociclib for previously untreated ER+/HER2- advanced breast cancer
Bardia A, Cortes J, Hurvitz S, Delaloge S, Iwata H, Shao Z-M, Kanagavel D, Cohen P, Liu Q, Cartot-Cotton S, Pelekanou V, O’Shaughnessy J. Massachusetts General Hospital, Harvard Medical School, Boston, MA; International Breast Cancer Center (IBCC), Barcelona, Spain; UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA; Institute Gustave Roussy, Villejuif, France; Aichi Cancer Center Hospital, Nagoya, Japan; Fudan University, Shanghai, China; Sanofi, Vitry-sur-seine, France; Sanofi, Cambridge, MA; Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX.
OT2-11-09 Lidera breast cancer: A phase III adjuvant study of giredestrant (GDC-9545) vs physician’s choice of endocrine therapy (ET) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+/HER2- EBC)
Bardia A, Schmid P, Harbeck N, Rimawi MF, Hurvitz SA, Loi S, Saji S, Jung KH, Werutsky G, Stroyakovskii D, López-Valverde V, Tesarowski D, Ye C, Davis M, Badovinac Crnjevic T, Perez-Moreno PD Geyer Jr CE. Massachusetts General Hospital, Harvard Medical School, Boston, MA; Barts Cancer Institute, London, United Kingdom; Breast Center, Department of Obstetrics and Gynecology and CCCMunich, LMU University Hospital, Munich, Germany; Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX; University of California, Los Angeles/Jonsson Comprehensive Cancer Center (UCLA/JCCC), Los Angeles, CA; Peter MacCallum Cancer Centre, Melbourn, Australia; Fukushima Medical University, Fukushima, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of Korea; Hospital São Lucas, PUCRS University, Porto Alegre, Brazil; City Clinical Oncology Hospital 62, Moscow, Russian Federation; F. Hoffmann-La Roche Ltd, Basel, Switzerland; Genentech, Inc, South San Francisco, CA; NSABP Foundation and Houston Methodist Cancer Center, Houston, TX.
   
  Surgery
OT2-12-01 Mastectomy with reconstruction including robot endoscopic surgery (MARRES): A prospective cohort study of the Korea robot-endoscopy minimal access breast surgery study group (KoREa-BSG)
Lee J, Ryu JM, Lee JY, Ko BS, Lee S, Kim JH, Choi HJ, Shin H-J, Chang YW, Lee HY, Kim H-K, Park HS. Samsung Medical Center, Seoul, Republic of Korea; Kyungpook National University School of Medicine, Daegu, Republic of Korea; University of Ulsan College of Medicine, Seoul, Republic of Korea; Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Republic of Korea; Samsung Changwon Hospital, Changwon, Republic of Korea; Myongji Hospital, Goyang, Republic of Korea; Korea University College of Medicine, Seoul, Republic of Korea; Seoul National University College of Medicine, Seoul, Korea, Republic of9Yonsei University, Seoul, Republic of Korea.
OT2-12-02 Feasibility study to evaluate performance of the LUM imaging system for intraoperative detection of residual tumor in patients with breast cancer receiving neoadjuvant therapy
Smith KP, Ferrer J, Webster A, Kelly B, Schlossberg B, Chang M Smith B. Lumicell, Inc, Newton, MA; Massachusetts General Hospital, Boston, MA.
OT2-12-03 Pivotal study of the Lum imaging system for assisting intraoperative detection of residual cancer in the tumor bed of female patients with breast cancer: The INCITE trial
Ferrer J, Carr D, Blumencranz P, Wapnir I, Dyess D, Hwang S, Dekhne N, Dodge D, Lesnikoski B-A, Hunt K, Clark P, Valente S, Lee MC, Clark L, Schlossberg B, Madden S, Rodriguez A, Smith K, Chang M, Smith B. Lumicell, Inc, Newton, MA; Novant Health, Raleigh, NC; Baycare Medical Center, Clearwater, FL; Stanford University, Palo Alto, CA; University of South Alabama, Mobile, AL; Duke University, Durham, NC; Beaumont Health, Royal Oak, MI; Penn State Medical Center, Hershey, PA; Baptist MD Anderson Cancer Center, Jacksonville, FL; MD Anderson Medical Center, Houston, TX; Honor Health Medical Center, Scottsdale, AZ; Cleveland Clinic, Cleveland, OH; Moffitt Cancer Center, Tampa, FL; CHI Franciscan, Tacoma, WA; Massachusetts General Hospital, Boston, MA.
   
  Survivorship
OT2-13-01 Supervised training exercise program during chemotherapy for breast cancer (STRENGTH) trial
Teplinsky E, Podolski A, Burke B, Bessada K, Klein L, Christoudias M, Abbate K. Valley Health System, Paramus, NJ.
   
  Targeted therapy - AKTi
OT2-14-01 CAPItello-292: A phase Ib/III study of capivasertib, palbociclib and fulvestrant, versus placebo, palbociclib and fulvestrant, for endocrine therapy-resistant HR+/HER2− advanced breast cancer
Rugo HS, Schiavon G, Grinsted LM, De Bruin EC, Catanese MT, Hamilton E. UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, CA; AstraZeneca, Cambridge, United Kingdom; Sarah Cannon Research Institute, Nashville, TN.
   
  Targeted therapy - anti-HER2/3 antibodies
OT2-15-01 Updated analysis of MCLA-128 (zenocutuzumab), trastuzumab, and vinorelbine in patients (pts) with HER2 positive/amplified (HER2+) metastatic breast cancer (MBC) who progressed on previous anti-HER2 ADCs
Hamilton E, Petit T, Pistilli B, Goncalves A, Ferreira AA, Dalenc F, Cardoso F, Mita MM, Manso L, Karim SM, Bidard F-C, Aftimos P, Escriváa-de-Romaníi S, Afonso N, Wasserman E, Bol K, Stalbovskaya V, Vliet A, Murat A, Bekradda M, Bachelot T. Tennessee Oncology and Sarah Cannon Research Institute, Nashville, TN; Institut de Cancérologie Strasbourg – Europe, Strasbourg, France; Gustave Roussy, Villejuif, France; Institut Paoli-Calmettes, Marseille, France; Centro Hospitalar e Universitario do Porto, Porto, Portugal; Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France; Champalimaud Clinical Center/Champalimaud Foundation, Breast Unit, Lisbon, Portugal; Cedars-Sinai Comprehensive Cancer Center, Los Angeles, CA; Hospital 12 de Octubre, Madrid, Spain; Sarah Cannon Cancer Institutes HCA Midwest Health, Overland, KS; Institut Curie, Institut Curie, France; Institut Jules Bordet, Brussels, Belgium; Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Medical Oncology Service, Barcelona, Spain; Merus N.V., Utrecht, Netherlands; Oncology Therapeutic Development, Clichy, France; Centre Léon Bérard, Lyon, France.
   
  Targeted therapy - antiprogestin onapristone
OT2-16-01 The SMILE study: A phase 2 trial of onapristone in combination with fulvestrant for patients with ER+ and HER2- metastatic breast cancer after progression on endocrine therapy and CDK4/6 inhibitors
Kamaraju S, Fowler A, Cheng CY, Chaudhary LN, Burfeind J, Retseck J, Tevaarwerk AJ, Burkard M, Paplomata E, Parkes AM, Jorns JM, Tarima S, Yee D, Rui H, Lange C, Sahmoud T, Wisinski KB. Medical College of Wisconsin, Milwaukee, WI; University of Wisconsin - Madison, Madison, WI; University of Minnesota, Minneapolis, MN; University of Minnesota, Minneapolis, WI; Context Therapeutics, Philadelphia, PA.
   
  Targeted therapy - AR
OT2-17-01 Randomized, multicenter, international phase 3 ARTEST study to evaluate the efficacy and safety of enobosarm versus active control for the treatment of AR+ ER+ HER2- metastatic breast cancer in patients who progressed on a nonsteroidal aromatase inhibitor, fulvestrant and CDK 4/6 inhibitor
Brufsky A, Linden H, Rugo H, Vogel C, O'Shaughnessy JA, Getzenberg RH, Barnette KG, Rodriguez D, Steiner MS, Mayer E. Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, PA; University of Washington/ Seattle Cancer Care Alliance, Seattle, WA; University of California San Francisco, San Francisco, CA; Miami Cancer Institute, Baptist Health, Miami, FL; Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX; Veru Inc, Miami, FL; Dana Farber Cancer Institute, Boston, MA.
   
  Targeted therapy - BRCA mutants
OT2-18-01 Harnessing olaparib, palbociclib, and endocrine therapy (HOPE): Phase I/II trial of olaparib, palbociclib and fulvestrant in patients with BRCA1/2-associated, hormone receptor-positive, HER2-negative metastatic breast cancer
Torres A, Kokkonen C, Oladeji M, D'Andrea K, Mick R, Narayan V, Mallamaci M, Ewing G, Knollman H, Tung NM, Robson M, Nathanson KL, Domchek S, Shah PD. University of Pennsylvania School of Medicine, Philadelphia, PA; AstraZeneca, Wilmington, DE; Beth Israel Deaconess Medical Center, Boston, MA; Memorial Sloan Kettering Cancer Center, New York, NY.
   
  Targeted therapy - CDK4/6i
OT2-19-01 Presurgical treatment with ribociclib and letrozole in patients with locally advanced breast cancer: The NEOLETRIB study
Tekpli X, Goel S, Holm B, Fallang L-E, Cornelus Reitsma L, Beate Geisler S, Presterud Ødegård H, Bergquist Fosskaug C, Lindem IC, Seyedzadeh M, Terje Geitung J, Reis J, Inge Gjesdal K, Buvarp U-C, Loeng M, Kleivi Sahlberg K, Porojnicu AC, Skjerven HK, Tahiri A, Jabeen S, Lüders T, Bemanian V, Jahnsen J, Lyngra M, Hurtado A, Carroll J, Chen S, Kristensen V, Geisler J. Department of Medical Genetics, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo & Oslo University Hospital, Oslo, Norway; Peter MacCallum Cancer Centre & The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Novartis, Medical Affairs Oncology, Kista, Sweden; Novartis, Medical Affairs Oncology, Oslo, Norway; Department of Breast and Endocrine Surgery, Akershus University Hospital, Oslo, Norway; Department of Oncology, Akershus University Hospital, Oslo, Norway; Department of Radiology, Akershus University Hospital, Oslo, Norway; University of Oslo, Institute of Clinical Medicine & Department of Radiology, Akershus University Hospital, Oslo, Norway; Norwegian University of Science and Technology, Trondheim, Norway; Department of Research and Innovation, Vestre Viken Hospital Trust and Department of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway; Department of Surgery, Section of Oncology, Drammen Hospital, Vestre Viken Hospital Trust, Drammen, Norway; Department of Surgery, Section of Breast and Endocrine Surgery, Drammen Hospital, Vestre Viken Hospital Trust, Drammen, Norway; Department of Medical Genetics, Oslo University Hospital, Ullevål & Department of Clinical Molecular Biology (EPIGEN), Akershus University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo & Department of Clinical Molecular Biology (EPIGEN), Akershus University Hospital, Oslo, Norway; Department of Gene Technology, Akershus University Hospital, Oslo, Norway; University of Oslo, Institute of Clinical Medicine & Department of Gastroenterology, Akershus University Hospital, Oslo, Norway; Department of Pathology, Akershus University Hospital, Oslo, Norway; Cancer Genomics and Proteomics Group, Department of Biomedical Sciences, University of Barcelona & August Pi i Sunyer Research Center (IDIBAPS), Barcelona, Barcelona, Spain; Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, United Kingdom; Department of Cancer Biology, Beckman Research Institute of City of Hope, Duarte, CA; Department of Medical Genetics, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo & Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Ullevål, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo & Department of Oncology, Akershus University Hospital, Oslo, Norway.
OT2-19-02 Clinical evaluation of the efficacy and liquid molecular analysis of abemaciclib rechallenge upon progression to abemaciclib combination therapies for ER-positive HER2-negative metastatic breast cancer patients
Nishimura M, Kogawa T, Akaishi Y, Ogata M, Masuda J, Terada M, Sakai H, Nozawa K, Kurozumi S, Yokoe T, Ozaki Ozaki Y, Yazaki S, Onishi M, Iwasa T, Onoe T, Okumura Y, Nakayama S, Hagio K, Takahashi Y, Tanino H, Tsurutani J, Matsumoto K, Shimokawa M, Takano T. Department of Medical Oncology/Hematology, Kobe University hospital, Kobe, Japan; Division of Early Clinical Development for Cancer, Advanced Medical Development Center, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan; Department of Medical Oncology, Hyogo Cancer Center, Akashi, Japan; Department of Breast Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Department of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan; Department of Clinical Oncology, Breast Oncology Aichi Cancer Center Hospital, Nagoya, Japan; Department of Breast Surgery, International University of Health and Welfare, Chiba, Japan; Department of Translational Molecular Medicine, Saint John’s Cancer Institute, Santa Monica, CA; Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Kobe, Japan; Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan; Department of Internal Medicine, Kyushu University Beppu Hospital, Oita, Japan; Department of Breast Surgical Oncology, Showa University Hospital, Tokyo, Japan; Department of Breast Surgery, Hokkaido University Hospital, Sapporo, Japan; Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan; Department of Breast Surgery, Kobe University Hospital, Kobe, Japan; Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
OT2-19-03 Solti-1801. Analysis of the efficacy of CDK4/6 inhibitors in combination with hormonal treatment in luminal breast cancer in relation to the intrinsic subtype and markers of immunity (CDK-predict)
Tolosa P, Pascual T, Hernando C, Servitja S, Fernández Abad M, Brasó-Maristany F, Benítez J, Lema L, Martínez M, Ruano Y, Parrilla L, Bernardini A, Roncero AM, Paré L, Canes J, Villagrasa P, Salvador F, Prat A, Ciruelos E. Medical Oncology Department, Hospital 12 de Octubre, Madrid, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain; Hospital Clínico Universitario de Valencia, Valencia, Spain; Hospital del Mar, Barcelona, Spain; Hospital Universitario Ramón y Cajal, Madrid, Spain; Hospital Clinic de Barcelona/August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Oncology Department, Hospital Clínico San Carlos, Madrid, Spain; Pathology Department, Hospital Universitario 12 de Octubre, Madrid, Spain; Molecular Pathology Unit, Hospital Universitario 12 de Octubre Research Institute, Madrid, Spain; Molecular Oncology Unit CIEMAT/Biomedical Research Institute, University Hospital "12 de Octubre", Madrid, Spain; SOLTI Breast Cancer Research Group/Hospital Clinic de Barcelona/August Pi i Sunyer Biomedical Research Institute (IDIBAPS)/Medicine Department, University of Barcelona, Barcelona, Spain; SOLTI Breast Cancer Research Group/Hospital 12 de Octubre, Madrid, Spain.
OT2-19-04 European treatment patterns and outcomes associated with first-line CDK4/6 inhibition and hormonal therapies assessed in a real-world non-interventional study (EUCHARIS)
Law EH, Galve-Calvo E, Wöckel A, Parikh R, Kurosky SK, Derrien Ansquer V, Frugier G, Davis KL, Esterberg EJ, Oikonomidou O. Pfizer Inc, New York, NY; Osakidetza, Bilbao, Spain; Universitätsklinikum Würzburg, Würzburg, Germany; RTI Health Solutions, Research Triangle Park, NC; RTI Health Solutions, Lyon, France; University of Edinburgh, Edinburgh, United Kingdom.
OT2-19-05 A phase I/II trial of abemaciclib and T-DM1 in women and men with HER2-positive advanced or metastatic breast cancer that has progressed on treatment with a taxane, trastuzumab and pertuzumab (THP) (ACCRU-BR-1801)
Sullivan CCO, He J, Suman VJ, Kalari KR, Leon-Ferre RA, Villasboas-Bisneto JC, Chalasani P, Gokalp Yasar D, Anderson DM, Stella PJ, Jaslowski AJ, Tannenbaum SH, Saverimuthu A, Northfelt D, Moreno-Aspitia A, Carter JM, Liu MC, Wang L, Lou Z, Goetz MP. Mayo Clinic, Rochester, MN; Carle Cancer Institute, Urbana, IL; Marshfield Medical Center, Minocqua, WI; Regions Hospital-Cancer Care Center, Saint Paul, MN; IHA Hematology Oncology at St. Joe's Ann Arbor, Ann Arbor, MI; UConn Health, Farmington, CT; Yuma Regional Medical Center, Yuma, AZ; Mayo Clinic, Scottsdale, AZ;9Mayo Clinic, Jacksonville, FL.
OT2-19-06 Phase 2 study of abemaciclib in combination with endocrine therapy with or without paclitaxel induction in patients with hormone receptor-positive, HER2-negative advanced breast cancer and aggressive disease criteria: ABIGAIL
Llombart-Cussac A, Gligorov J, Di Cosimo S, Albacar C, Cortez P, Martinez-De Dueñas E, López A, Carañana V, Medioni J, Cavanna L, Cazzaniga ME, Braga S, Coelho P, Sampayo-Cordero M, Malfettone A, Pérez-García JM, Cortes J. Hospital Arnau de Vilanova; FISABIO; Universidad Católica de Valencia; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Institut Universitaire de Cancérologie AP-HP. Sorbonne Université, Paris, France; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Hospital Sant Joan de Reus, Reus, Spain; IOB Institute of Oncology, Hospital Ruber Internacional, Quiron Group, Madrid, Spain; Hospital Provincial Castellón, Castelló De La Plana, Spain; Hospital Universitario de León, León, Spain; Hospital Arnau de Vilanova, Valencia, Spain; Hôpital Européen Georges Pompidou AP-HP, Paris, France; Azienda Ospedaliera Piacenza, Piacenza, Italy; School of Medicine and Surgery, University of Milano-Bicocca; ASST-Monza, Monza, Italy; Hospital Prof. Doutor Fernando Fonseca, Amadora, Portugal; Hospital Da Luz Lisboa, Lisbon, Portugal; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; International Breast Cancer Center (IBCC), Quironsalud Group; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain16International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR); Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
OT2-19-07 A phase I/Ib trial of the CDK4/6 antagonist ribociclib (RIB) and the HDAC inhibitor belinostat (BEL) in patients with metastatic triple negative breast cancer and recurrent ovarian cancer with response prediction by genomics (CHARGE)
Sama S, Kelley K, Vaklavas C, Bild A, Boucher K, Lamb J, Lehman J, Moos P, Werner T, Cohen A. University of Utah, Salt Lake City, UT; Huntsman Cancer Institute, Salt Lake City, UT; Department of Medical Oncology & Therapeutics Research, City of Hope National Medical Center, Duarte, CA; University of Utah, Department of Pharmacology and Toxicology, Salt Lake City, UT; Inova Schar Cancer Institute, Fairfax, VA.
OT2-19-08 Phase IB/II trial of palbociclib and binimetinib in advanced triple-negative breast cancer with hyperactivation of ERK and/or CDK4/6
Manso L, Cortes A, Cejalvo JM, Morales S, García Saenz JA, Colomer R, Sanchez-Bayona R, Silva J, Guerra JA, Malon D, Mouron S, Caleiras E, Quintela-Fandino M. Hospital 12 de Octubre, Madrid, Spain; Hospital Universitario Ramon y Cajal, Madrid, Spain; Hospital Clinico Universitario de Valencia, Valencia, Spain; Hospital Arnau de Vilanova, Lleida, Spain; Hospital Universitario Clinico San Carlos, Madrid, Spain; Hospital Universitario La Princesa, Madrid, Spain; Hospital Universitario de Fuenlabrada, Madrid, Spain; CNIO, Madrid, Spain.
   
  Targeted therapy - FGFR1/2+ BC
OT2-20-01 Rogaratinib, palbociclib and fulvestrant in advanced hormone receptor-positive (HR+), FGFR1/2-positive breast cancer: Phase I trial plus an expansion cohort
Pernas S, Hernando C, Bermejo B, Martinez-Jañez N, García Saenz JA, Morales S, Manso L, Silva J, Guerra JA, Malon D, Mouron S, Caleiras E, Quintela-Fandino M. Institut Catala d'Oncologia-H.U.Bellvitge-IDIBELL, L´Hospitalet-Barcelona, Spain; Hospital Clinico Universitario de Valencia, Valencia, Spain; Hospital Universitario Ramon y Cajal, Madrid, Spain; Hospital Universitario Clinico San Carlos, Madrid, Spain; Hospital Arnau de Vilanova, Lleida, Spain; Hospital 12 de Octubre, Madrid, Spain; Hospital Universitario de Fuenlabrada, Fuenlabrada, Spain; CNIO, Madrid, Spain.
   
  Targeted therapy - filgrastim vs. peg-filgrastim - bone pain
OT2-21-01 A randomized, multicenter pragmatic trial comparing bone pain from a single dose of pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant / adjuvant chemotherapy (REaCT-5G)
Ng TL, Taljaard M, Savard M-F, Stober C, Nicholls S, Vandermeer L, Thavorn K, Hampel C, Shamess J, Mills N, Hilton JF, Clemons M. University of Ottawa, Ottawa, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada; The Ottawa Hospital, Ottawa, ON, Canada.
   
  Targeted therapy - HDAC inhibitors
OT2-22-01 Rationale and design of a phase 1b/2 trial of OKI-179, an oral class 1-selective depsipeptide HDAC inhibitor, in combination with tamoxifen in patients with previously treated metastatic ER+ HER2- breast cancer
Kabos P, Kagihara JA, Heim AM, Piscopio AD, Winkler JD, Diamond JR. University of Colorado Anschutz Medical Campus, Aurora, CO; OnKure Therapeutics, Boulder, CO
   
  Targeted therapy - MAPK pathway
OT2-23-01 A Phase 1b / 2a, open-label platform study to evaluate mirdametinib in combination with fulvestrant in ER+ metastatic breast cancers harboring MAPK-activating mutations
Rosen EY, Patel P, Sarapa N, Edris B, Iasonos A, Jhaveri K, Razavi P, Robson M, Drilon A, Berger MF, Solit DB, Chandarlapaty S. Memorial Sloan Kettering Cancer Center, New York, NY; SpringWorks Therapeutics, Stamford, CT.
   
  Targeted therapy - PARPi's
OT2-24-01 PARTNER: Randomised, phase II/III trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in triple negative and/or germline BRCA mutated breast cancer patients
Drewett LM, Pinilla KA, Grybowicz L, Wulff J, Dayimu A, Demiris N, Martin J, de Pontes CM, Johnson N, Harvey C, Demir E, St John Green K, Jones J, Young G, Vallier A-L, Qian W, Machin A, McAdam K, Roylance R, Copson ER, Armstrong A, Levitt N, Provenzano E, Tischkowitz M, McMurtry E, Earl H, Abraham JE. The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom; The University of Cambridge and Cancer Research UK Cambridge Centre, Cambridge, United Kingdom; Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom; Cambridge Clinical Trials Unit, Cambridge, United Kingdom; University College London Hospitals NHS Foundation Trust, London, United Kingdom; Cancer Sciences Academic Unit, University of Southampton, Southampton, United Kingdom; The Christie NHS Foundation Trust, Manchester, United Kingdom; Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom; The University of Cambridge, Cambridge, United Kingdom; EMC2 Clinical Consultancy, Manchester, United Kingdom; The University of Cambridge and NIHR Cambridge Biomedical Research Centre, Cambridge, United Kingdom; The University of Cambridge, Cambridge University Hospitals NHS Foundation Trust and Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.
OT2-24-02 ZEST: Randomized phase III study evaluating efficacy and safety of niraparib in patients with HER2-negative BRCA-mutated or triple-negative breast cancer with detectable circulating tumor DNA after definitive therapy
Turner NC, Cescon DW, Loibl S, Janni W, Rugo H, Balmaña J, Crowley C, Chung J, Fucli G, Hofstatter E, Frenkl T, Telli ML. Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital and Institute of Cancer Research, London, London, United Kingdom; Princess Margaret Cancer Centre, University Health Network of Toronto, Toronto, ON, Canada; German Breast Group, Neu-Isenburg, Germany; Ulm University Hospital, Ulm, Germany; University of California San Francisco, San Francisco, CA; Vall d’Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Barcelona, Spain; GlaxoSmithKline, Waltham, MA; GlaxoSmithKline, Philadelphia, PA; Stanford University School of Medicine, Stanford, CA.
OT2-24-03 Phase II study of a PARP inhibitor in metastatic breast cancer with somaticBRCA1/2mutations identified by cell-free DNA: Genotyping based clinical trial
Vidula N, Blouch E, Basile E, Ruffle-Deignan NR, Horick N, Damodaran S, Moreno Aspitia A, Bhave M, Shah A, Liu MC, Sparano J, Ostrer H, Rugo H, Ellisen LW, Bardia A. Massachusetts General Hospital, Boston, MA; MD Anderson, Houston, TX; Mayo Clinic, Jacksonville, FL; Emory University, Atlanta, GA; Northwestern University, Chicago, IL; Mayo Clinic, Rochester, MN; Albert Einstein Medical Center, Bronx, NY; Albert Einstein College of Medicine, Bronx, NY; University of California San Francisco, San Francisco, CA.
   
  Targeted therapy - PD-1i + oncolytic virus
OT2-25-01 Irene study: Phase 2 study of Incmga00012 and the oncolytic virus pelareorep in metastatic triple negative breast cancer
George M, Williams N, Omene C, Chan N, Lu S-E, Tang D, Wilkinson G, Ganesan S, Toppmeyer D. Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ohio State University Comprehensive Cancer Center, Columbus, OH; Rutgers School of Public Health, New Brunswick, NJ; Oncolytics Biotech, Calgary, ON, Canada.
   
  Targeted therapy - T-DXd, brain mets
OT2-26-01 Open-label, multinational, multicenter, phase 3b/4 study of trastuzumab deruxtecan (T-DXd) in patients with or without baseline brain metastasis with previously treated advanced/metastatic human epidermal growth factor receptor 2-positive breast cancer (HER2+ BC): DESTINY-Breast12
Lin NU, Ciruelos E, Jerusalem G, Müller V, Niikura N, Viale G, Oscroft E, Anand S, Walker G, Harbeck N. Dana-Farber Cancer Institute, Boston, MA; University Hospital 12 de Octubre, Madrid, Spain; Centre Hospitalier Universitaire du Sart Tilman Liège and Liège University, Liège, Belgium; University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Tokai University School of Medicine, Kanagawa, Japan; European Institute of Oncology, Milan, Italy; AstraZeneca Pharmaceuticals, Gaithersburg, MD; Breast Center, LMU University Hospital, Munich, Germany.
   
  Targeted therapy - TKIs
OT2-27-01 Solti-1718 NEREA Trial: Neratinib in hormone receptor (HR)-positive/HER2-negative HER2-enriched (HER2-E) advanced breast cancer (BC)
Ciruelos E, Saura C, González-Farré X, Bofill JS, Vidal M, Blancas I, López-Miranda E, Iglesias M, Arumi M, Margelí M, Pulido C, Morales S, Henao F, Sánchez P, Alves S, Branco D, Manel Gasent J, Sánchez-Rovira P, Godoy A, Passos-Coelho JL, Escrivá-de-Romaní S, Ferrero-Cafiero JM, Pascual T, Prat A. Medical Oncology Department, Hospital 12 de Octubre / SOLTI Breast Cancer Research Group, Madrid/Barcelona, Spain; Medical Oncology Department, Vall d'Hebron University Hospital/SOLTI Breast Cancer Research Group/Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; Medical Oncology Department, Hospital General de Catalunya, Sant Cugat del Vallès, Spain; Medical Oncology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain; Medical Oncology Department, Hospital Clínic de Barcelona/SOLTI Breast Cancer Research Group/Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; Oncology Unit. Hospital Universitario Clínico San Cecilio, Granada, Spain; Medical Oncology Department, Hospital Ramon y Cajal, Madrid, Spain; Medical Oncology Department, Hospital Son Llatzer, Palma, Illes Balears, Spain; Medical Oncology Department, Vall d'Hebron University Hospital / Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO)/Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; Medical Oncology Department, ICO Badalona, Institut Català d’Oncologia, Barcelona, Spain; Medical Oncology Department, Hospital da Luz Lisboa, Lisboa, Portugal; Medical Oncology Department, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain; Medical Oncology Department, Hospital Virgen Macarena, Sevilla, Spain; Hospital Universitario Virgen de la Arrixaca, Murcia, Spain; Medical Oncology Department, Instituto Português de Oncologia do Porto FG, EPE (IPO-Porto), Porto, Portugal; Medical Oncology Department, Instituto Português de Oncologia de Lisboa FG (IPO-Lisboa), Lisboa, Portugal; Medical Oncology Department, Hospital Marina Salud Denia, Denia, Spain; Medical Oncology Department, Hospital Universitario de Jaén, Jaén, Spain; Medical Oncology Department, Vall d'Hebron University Hospital / Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain; SOLTI Breast Cancer Research Group/ Medical Oncology Department, Hospital Clínic de Barcelona / Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute/Medicine Department, University of Barcelona, Barcelona, Spain.
OT2-27-02 A prospective phase II study on efficacy and safety of anlotinib combined with fulvestrant in patients with HR-positive and HER2-negative, secondary endocrine-resistant, locally advanced or metastatic breast cancer
Wang X, Huang J. Department of Breast Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Hangzhou, China.
   
  Targeted therapy - tyrosine kinase inhibitors
OT2-28-01 A phase 2 study of sitravatinib in metastatic, pre-treated, triple negative breast cancer, NCT # 04123704
Nemati Shafaee M, Otte K, Neill NJ, Osborne KC, Westbrook TF, Hilseneck S, Ellis MJ. Baylor College of Medicine, Houston, TX.
   
  TNBC - checkpoint inhibitors
OT2-29-01 neoMono - An adaptive randomized neoadjuvant two arm trial in patients with TNBC comparing a mono atezolizumab window followed by atezolizumab and chemotherapy with atezolizumab and chemotherapy
Kolberg-Liedtke C, Schumacher J, Erber R, Braun M, Heinrich B, Hoffmann O, Fasching P, Forstbauer H, Kleine-Tebbe A, Kunz G, Lux M, Rom J, Schem C, Stahl N, Hartmann A, Kasimir-Bauer S, Kolberg H-C. Phaon Scientific / University Hospital Essen, Wiesbaden / Essen, Germany; Palleos Healthcare, Wiesbaden, Germany; Institute of Pathology, University Hospital Erlangen, Erlangen, Germany; Phaon Scientific, Wiesbaden, Germany; Hämatologisch-Onkologische Praxis Augsburg, Augsburg, Germany; Universitätsklinikum Essen, Essen, Germany; University Hospital Erlangen, Erlangen, Germany; Onkologie Rheinsieg, Rheinsieg, Germany; Klinikum Köpenick, Berlin, Germany; St. Johannes Spital Dortmund, Dortmund, Germany; Klinikum Paderborn, Paderborn, Germany; Klinikum Frankfurt, Frankfurt, Germany; Mammazentrum Hamburg, Hamburg, Germany; Helios Kliniken Schwerin, Schwerin, Germany; University of Erlangen, Institute of Pathology, Erlangen, Germany16Phaon Scientific / Marienhospital Bottrop, Wiesbaden / Bottrop, Germany.
   
  TNBC - neoadjuvant chemotherapy
OT2-30-01 Nordictrip, a translational randomized phase-3study exploring the effect of the addition of capecitabine to carboplatinum-based chemotherapy in early “triple negative” breast cancer, ClinicalTrials.gov Identifier: NCT04335669
Loman N, Linderholm B, Ahlgren J, Kimbung S, Zander L, Grill Magnusson H, Kjellman E-C, Raaberg AJ, Raaby Jensen M-B, Borg Å, Staaf J, Ståhlberg A, Bendahl P-O, Laenkholm A-V, Tanner M, Bjarnadóttir O, Johannsson O, Ejlertsen B, Lindman H. Dept of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Sweden; Dept of Oncology, Jubileumskliniken, Sahlgrenska University Hospital, Sweden; Regional Cancer Center, Central Sweden, Uppsala, Sweden; Division of Oncology, Dept of Clinical Sciences Lund, Lund University, Sweden; Danish Breast Cancer Group, Rigshospitalet, Copenhagen, Denmark; Insititute of Biomedicine, University of Gothenburg, Sweden; Dept of Surgical Pathology, Zeeland University Hospital, Roskilde, Denmark; Dept of Oncology, Tampere University Hospital, Finland; Dept of Oncology, Landspitali, Reykjavik, Iceland; Dept of Oncology, Akademiska Hospital, Uppsala, Sweden.