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43rd Annual Miami Breast Cancer Conference® - Abstracts

93 monarchE: Primary Overall Survival Results of Adjuvant Abemaciclib + Endocrine Therapy for HR+/HER2−, High-Risk, Early Breast Cancer

ByStephen R.D. Johnston,Miguel Martin, MD, PhD,Joyce O’Shaughnessy, MD,Roberto Hegg,Sara M. Tolaney, MD, MPH,Valentina Guarneri, MD,Lucia Del Mastro,Mario Campone,Javier Cortés, MD,Hope S. Rugo, MD,Matthew P. Goetz, MD,Erika P. Hamilton, MD,Elzbieta Senkus,Laura Testa,Patrick Neven, MD, PhD,Jens Huober, MD,Ran Wei,Maria Munoz,Priya Rastogi, MD,Nadia Harbeck, MD, PhD,Victoria Jennifer Stefaniak (Non-Author Presenter)

95 monarchE: Subgroup Analysis of Adjuvant Abemaciclib + Endocrine Therapy for HR+/HER2−, High-Risk, Early Breast Cancer by Nodal Status

ByJavier Cortés, MD,Stephen R.D. Johnston,Miguel Martin, MD, PhD,Sara M. Tolaney, MD, MPH,Matthew P. Goetz, MD,Hope S. Rugo, MD,Joohyuk Sohn,Ozgur Ozyilkan,Miguel Henriques Abreu,Matthias Zaiss,Karina Maia Vianna,Hanne Melgaard Nielsen,Arlene Chan,Haralambos Kalofonos, MD,Serafin Morales,Belen San Antonio,Maria Munoz Fernandez,Sasha Amdur,Patrick Neven, MD, PhD,Brenda Grimes

98 A Phase 1/2 Trial of LY4064809, A Pan-Mutant-Selective PI3Kα Inhibitor in HR+/HER2− Advanced Breast Cancer, Updated Results From PIKALO-1

ByKomal L. Jhaveri,Dejan Juric,Antonio Giordano,Antoine Italiano,Gennaro Daniele,Jordi Rodón,Amita Patnaik, MD,Jorge Bartolomé,Anthony D. Elias, MD,Pamela N. Munster, MD,Patricia Lorusso, DO,Aixa Soyano,Maria de Miguel,Joyce O’Shaughnessy, MD,Robert Wesolowski,Giuseppe Curigliano,Tatiana Hernández,Aurélie Lombard,Shawn T. Estrem,Lin Du,Xiaofan Xu,Alberto J. Montero, MD, MBA, CPHQ

99 Imlunestrant With or Without Abemaciclib in Advanced Breast Cancer: Updated Efficacy Results From the Phase 3 EMBER-3 Trial

ByKomal L. Jhaveri,Patrick Neven, MD, PhD,Monica Lis Casalnuovo,Sung-Bae Kim,Eriko Tokunaga,Phillippe Aftimos,Cristina Saura,Joyce O’Shaughnessy, MD,Nadia Harbeck, MD, PhD,Lisa A. Carey, MD,Giuseppe Curigliano,Junichiro Watanabe,Elgene Lim, MBBS, FRACP, PhD,Juan Huang,Qingyuan Zhang,Antonio Llombart-Cussac,Chiun-Sheng Huang,Bhardwaj Desai,Xuejing Aimee Wang,Shanshan Cao,Francois Clement Bidard

100 Imlunestrant Plus Abemaciclib Versus Fulvestrant Plus Abemaciclib in Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2–) Advanced Breast Cancer (ABC): An Indirect Treatment Comparison (ITC) of Three Phase 3 Trials

ByKomal L. Jhaveri,Francois Clement Bidard,Kevin Kalinsky, MD, MS,Patrick Neven, MD, PhD,Hope S. Rugo, MD,Sara M. Tolaney, MD, MPH,Lacey Litchfield,Christoph Cramer von Laue,Sory Traore,Francisco Sapunar,Yujia Li,Joyce O’Shaughnessy, MD

101 Patient-Reported Outcomes (PROs) in Patients With ER+, HER2- Advanced Breast Cancer (ABC) Treated with Imlunestrant, Investigator’s Choice Standard Endocrine Therapy, or Imlunestrant+Abemaciclib: Results From the Phase III EMBER-3 Trial

ByGiuseppe Curigliano,Joyce O'Shaughnessy, MD,François-Clément Bidard,Sung-Bae Kim,Eriko Tokunaga,Philippe Aftimos,Cristina Saura,Lisa A. Carey, MD,Meena Okera,Everton Melo,Flora Zagouri,Manuel Ernesto Magallanes Maciel,Nuri Karadurmus,Shakeela Bahadur,Rebecca M Speck,Xuejing Aimee Wang,Suzanne Young,Komal L. Jhaveri,Nadia Harbeck, MD, PhD

102 Imlunestrant (imlu) With or Without Abemaciclib (abema) in Advanced Breast Cancer (ABC): Safety Analyses From the Phase III EMBER-3 Trial

ByJoyce O’Shaughnessy, MD,Francois Clement Bidard,Patrick Neven, MD, PhD,Monica Lis Casalnuovo,Philippe Aftimos,Cristina Saura,Nadia Harbeck, MD, PhD,Lisa A. Carey, MD,Giuseppe Curigliano,J A Garcia-Saenz,Maria Fernandez Abad,Larissa de Paula,Yeon Hee Park,Ozgur Ozyilkan,Maria Munoz,Sabrina Formentini,Emily Barrett,Shanshan Cao,Aarti Chawla,Komal L. Jhaveri

TIP103 Randomized Phase 3 Clinical Trial Evaluating Atirmociclib Plus Letrozole Versus a CDK4/6 Inhibitor Plus Letrozole as First-Line Treatment for Patients With HR+/HER2− Advanced/Metastatic Breast Cancer

ByFrancois Clement Bidard,Michail Ignatiadis,Giuseppe Curigliano,Binghe Xu,Theresa Link,Yoichi Naito,Huiping Li,Madoka Iwase,Mark A. Taylor,Carlos H Barrios,Tomofumi Osako,Kevin Kalinsky, MD, MS,Antonio Giordano,Shom Goel, MD,Libero Santarpia,Jason Quan Gong,Kathrine C. Fernandez,Zhe Zhang,Hope S. Rugo, MD

107 Updated Results and an Exploratory Analysis of ESR1 Mutations (ESR1m) Circulating Tumor DNA (ctDNA) Dynamics From SERENA-6, a Phase III Trial of Camizestrant + CDK4/6 Inhibitor (CDK4/6i) for Emergent ESR1m During First-Line (1L) Endocrine-Based Therapy and Ahead of Disease Progression in Patients With HR+/HER2– Advanced Breast Cancer (ABC)

ByAdam M. Brufsky, MD, PhD,François-Clément Bidard,Erica L. Mayer, MD, MPH,Yeon Hee Park,Wolfgang Janni,Cynthia X. Ma, MD, PhD,Massimo Cristofanilli, MD,Giampaolo Bianchini,Kevin Kalinsky, MD, MS,Hiroji Iwata,Stephen Chia,Peter A. Fasching,Zbigniew Nowecki,Javier Pascual,Einav Nili Gal-Yam,Wei-Pang Chung,Seock-Ah Im,Alberto Zambelli,Florence Dalenc,Mafalda Oliveira,Steven Fox,Manuel Selvi Miralles,Christopher Morrow,Cynthia Huang Bartlett,Nicholas C. Turner, MD

110 Randomized Phase II Trial Evaluating Three Anti-diarrheal Prophylaxis Strategies in Patients (pts) with HER2+/HR+ Early Breast Cancer (EBC) Treated with Extended Adjuvant Neratinib (Dianer Geicam/2018-06)

ByJ. Gil-Gil,M. Ruíz-Borrego,E. Carrasco,Y. Izarzugaza,C. Martínez-Vila,E. Galve,B. López-Barajas,E. Adrover,T. Silovski,M. Valero-Arbizu,Á. Guerrero-Zotano,S. González-Santiago,M. Echarri,A. Cano-Jiménez,A. Vethencourt-Casado,M. De Laurentis,C. Bueno-Muiño,B. Adamo,R. Andrés,C. Villanueva,F. Rojo,M. Casas,P. Wilson,J. Suissa,V. Adams,M. Martin

112 First-Line (1L) Datopotamab Deruxtecan (Dato-DXd) vs Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer (mTNBC) for Whom Immunotherapy Was Not an Option: Primary Results From the Randomized, Phase 3 TROPION-Breast02 Trial

ByRebecca Dent, MD,Zhimin Shao,Peter Schmid, MD,Javier Cortés, MD,David W. Cescon,Shighira Saji,Kyung Hae Jung,Thomas Bachelot,Shouman Wang,Gul Basaran,Yee Soo Chae,Rofhiwa Mathiba,Shin-Cheh Chen,Agostina Stradella,Nicola Battelli,Naoki Niikura,Kechen Zhao,Petra Vukovic,Michah Maxwell,Tiffany Traina, MD, FASCO

TIP113 HERTHENA-PanTumor01 (NCT06172478): Expansion of a Global Phase 2 Trial of HER3-DXd in Patients With Advanced/Metastatic HR+/HER2− Breast Cancer

ByFunda Meric-Bernstam, MD,Christos Fountzilas,Izuma Nakayama,Takahiro Kogawa,Tomohiro Nishina,Thomas Powles, MBBS, MCRP, MD,Jin Won Kim,Yen-Yang Chen,Francois Ghiringhelli,Valentina Gambardella,James W. Smithy,Jérome Fayette,Fan Jin,Y.K. Chang,Kendall Sullivan,Sue Yueh,Ajlan Atasoy,Andrea Sporchia,Ragini Kudchadkar, MD,Hidetoshi Hayashi

117 Risk of Recurrence (ROR) Among Patients With HR+/HER2− Early Breast Cancer (EBC) Involving 1-3 Axillary Lymph Nodes (N1): A Real-World Evaluation

ByPedram Razavi,Joyce O’Shaughnessy, MD,Lasika Seneviratne, MD,Mehnaj Ahmed,Ashley Roush,Siddhi Korgaonkar,Abigail Hitchens,Keith L. Davis,Anton Safonov,Mark Robson, MD,Yanjun Ma,Brittni Smith,Lorraine Brisbin,Siraje Mahmud,Laura Ensley,Robert Milford,Elan Ingram,Vaidyanathan Ganapathy,Corinth Auld,Mumbi E. Kimani,Liz Santarsiero,L. Johnetta Blakely, MD

119 Progression-Free Survival (PFS) and Overall Survival (OS) Results From the Phase 3 MONALEESA-3 Trial of Postmenopausal Patients With Hormone Receptor–Positive (HR+)/Human Epidermal Growth Factor Receptor 2–Negative (HER2−) Advanced Breast Cancer (ABC) Treated With Ribociclib (RIB) + Fulvestrant (FUL): A Subgroup Analysis of Patients With Invasive Lobular Carcinoma (ILC)

ByMichelino De Laurentiis,Jason Mouabbi,Seock-Ah Im,Megan Kruse, MD,Stephen Chia,Sara Brucker,Cristian Villanueva,Guy Jerusalem,Melissa Gao,Gary Sopher,Jiwen Wu,Juan Pablo Zarate,J. Thaddeus Beck

122 Adjuvant Ribociclib (RIB) Plus Nonsteroidal Aromatase Inhibitor (NSAI) in Patients With HR+/HER2− Early Breast Cancer (EBC): NATALEE 5-Year Outcomes

ByJohn Crown,Daniil Stroyakovskii,Denise A. Yardley, MD,Chiun-Sheng Huang,Peter A. Fasching,Aditya Bardia, MD, MPH, FASCO,Stephen Chia,Seock-Ah Im,Miguel Martin, MD, PhD,Binghe Xu,Carlos H Barrios,Michael Untch, MD, PhD,Rebecca Moroose,Sara A. Hurvitz, MD,Gabriel N. Hortobagyi, MD, FACP,Dennis J. Slamon, MD, PhD,Frances Visco,Gonzalo Spera,Zheng Li,Sherene Loi, MD, PhD