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43rd Annual Miami Breast Cancer Conference® - Abstracts

TIP125 ReDiscover-2, a Phase 3 Study of Zovegalisib (RLY-2608) + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-Mutant HR+/ HER2- Breast Cancer Following Recurrence or Progression on or After Treatment With a CDK4/6 Inhibitor (Trial in Progress)

ByHope S. Rugo, MD,Cristina Saura,Komal Jhaveri,Carlos Barrios,Sherene Loi, MD, PhD,Frederik Marme,Francois Clement Bidard,Yeon Hee Park,Peter Schmid, MD,Sarah L. Sammons,Giuseppe Curigliano

TIP126 TroFuse-011: A Phase 3, Randomized, Open-Label Study of Sacituzumab Tirumotecan With or Without Pembrolizumab vs Treatment of Physician’s Choice for Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer With PD-L1 Combined Positive Score <10

ByHope S. Rugo, MD,Peter Schmid, MD,Javier Cortés, MD,Toshimi Takano,Peter A. Fasching,Yeon Hee Park,Giampaolo Bianchini,Sandra Ximena Franco,Cynthia Villarreal-Garza,Olivier Tredan,Yongmei Yin,Romualdo Barroso-Sousa,Xuan Peng,Usha Malhotra, MD,Karen Lisa Smith,Aditya Bardia, MD, MPH, FASCO

130 Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro) Vs Chemotherapy (Chemo) + Pembro in Previously Untreated PD-L1–Positive Advanced Triple-Negative Breast Cancer (TNBC): Primary Results From the Randomized Phase 3 ASCENT-04/KEYNOTE-D19 Study

BySara M. Tolaney, MD, MPH,Evandro de Azambuja,Kevin Kalinsky, MD, MS,Sherene Loi, MD, PhD,Sung-Bae Kim,Clinton Yam,Bernardo Rapoport, MD,Seock-Ah Im,Barbara Pistilli,Wassim McHayleh,David W. Cescon,Junichiro Watanabe,Manuel Alejandro Lara Banuelas,Ruffo Freitas-Junior,Javier Salvador Bofill,Maryam Afshari,Dianna Gary,Lu Wang,Catherine Lai, MD, MPH,Peter Schmid, MD

131 Primary Results From ASCENT-03: A Randomized Phase 3 Study of Sacituzumab Govitecan (SG) vs Chemotherapy (Chemo) in Patients (pts) With Previously Untreated Advanced Triple-Negative Breast Cancer (TNBC) Who Are Unable to Receive PD-(L)1 Inhibitors (PD-[L]1i)

ByJavier Cortés, MD,Aditya Bardia, MD, MPH, FASCO,Kevin Punie,Carlos Barrios,Sara A. Hurvitz, MD,Andreas Schneeweiss, MD,Joohyuk Sohn,Eriko Tokunaga,Adam M. Brufsky, MD, PhD,Yeon Hee Park,Binghe Xu,Roberto Hegg,Mafalda Oliveira,Alessandra Fabi,Natalya Vaksman,Theresa Valdez,Xinrui Zhang,Catherine Lai, MD, MPH,Sara M. Tolaney, MD, MPH

135 Elacestrant in Combination With Everolimus or Abemaciclib in Patients With ER+/HER2– Locally Advanced or Metastatic Breast Cancer (mBC): Phase 2 Results From ELEVATE, an Open-Label, Umbrella Study

ByHope S. Rugo, MD,Sara M. Tolaney, MD, MPH,Nancy Chan,Giuliano Borges,Rinat Yerushalmi,Marina N. Sharifi,Wassim McHayleh,J. Thaddeus Beck,Neelima Vidula, MD,Erika P. Hamilton, MD,Kristine J. Rinn,Joyce O’Shaughnessy, MD,Giuseppe Curigliano,Javier Cortés, MD,Paula Muñoz Romero,Giulia Tonini,Alessandro Paoli,Monica Binaschi,Li Cheng,Jennifer Crozier,Tomer Wasserman,Virginia Kaklamani, MD, DSc

TIP136 ELEGANT: Elacestrant Versus Standard Endocrine Therapy (ET) in Women and Men With Node-Positive, Estrogen Receptor–Positive (ER+), HER2-Negative (HER2–), Early Breast Cancer (eBC) With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study

ByAditya Bardia, MD, MPH, FASCO,Virginia Kaklamani, MD, DSc,Joyce O’Shaughnessy, MD,Peter Schmid, MD,J. Thaddeus Beck,Michelino De Laurentiis,Giuseppe Curigliano,Hope S. Rugo, MD,Carlos H. Barcenas,William J. Gradishar, MD,Michail Ignatiadis,David Cameron,Giulia Tonini,Simona Scartoni,Jennifer Crozier,Tomer Wasserman,Sara M. Tolaney, MD, MPH

TIP137 ADELA: A Double-blind, Placebo-Controlled, Randomized Phase 3 Trial of Elacestrant + Everolimus Versus Elacestrant + Placebo in ER+/HER2- Advanced Breast Cancer (aBC) Patients With ESR1-Mutated Tumors Progressing on Endocrine Therapy (ET) + CDK4/6i

ByAntonio Llombart-Cussac,José Manuel Pérez-García,Elena Lopez-Miranda,Cristina Saavedra,Vicente Carañana,Isabel Blancas,Carmen Hinojo-González,Alfonso Cortes-Salgado,Elena Galve,Rui Rui Zhang,Miguel Sampayo-Cordero,Daniel Alcalá-López,Juliana Carvalho-Santos,Olga Boix,Ana Garrido,Carlos H Barrios,Giuseppe Curigliano,Rupert Bartsch,Anne Claire Hardy Bessard,Tomer Wasserman,Javier Cortés, MD

138 HER2CLIMB-05: A Randomized, Double-blind, Phase 3 Study of Tucatinib Versus Placebo Added to Trastuzumab and Pertuzumab as Maintenance Therapy for HER2+ Metastatic Breast Cancer

ByErika P. Hamilton, MD,Giuseppe Curigliano,Miguel Martin, MD, PhD,Florence Lerebours,Junji Tsurutani,Marie-France Savard,Katarzyna J. Jerzak, MD, MSc, FRCPC,Xichun Hu,Luciana Carla Martins de Aquino Pimentel,Ciara C. O’Sullivan,Eriko Tokunaga,Alicia Okines,Chiun-Sheng Huang,William Jacot,Joohyuk Sohn,Eduardo Cronemberger Silva,Volkmar Mueller,Helene Viala,Shan Yang,Giovanna Granata,Qi Shen,Libero Santarpia,Veronique Dieras