Brief Summary

The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

Conditions

• Breast Cancer

Intervention / Treatment

• Drug: Dato-DXd
• Drug: Capecitabine
• Drug: Gemcitabine
• Drug: Eribulin
• Drug: Vinorelbine

Primary Outcome Measures

• Progression-Free Survival (On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months)
  PFS is defined as time from randomization until progression per RECIST 1.1, as assessed by BICR, or death due to any cause. The analysis will include all randomized participants as randomized regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1.
• Overall Survival (From date of randomization until death due to any cause. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.)
  OS is defined as time from randomization until the date of death due to any cause. The comparison will include all randomized participants as randomized, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the hazard ratio of OS.

Countries

Argentina, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Netherlands, Poland, Russia, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States

Locations and Investigators

• Centre hospitalier universitaire de Liege, Liege, Belgium
  • Joelle, Collignon
• UZ Leuven, Leuven, Belgium
  • Hans, Wildiers
• Central Hospital Of Northern Pest Military Hospital, Budapest VI, Hungary
  • Zsuzsanna, Pápai
• Tolna Varmegyei Balassa Janos Korhaz, Szekszard, Hungary
  • Yousuf, Al-Farhat
• Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, Hungary
  • Tibor, Csőszi
• Orszagos Onkologiai Intezet, Budapest XII, Hungary
  • Gábor László, Rubovszky
• Hospital Universitario Basurto, Bilbao, Spain
  • Elena, Galve Calvo
• Hospital Universitario Ramon Y Cajal, Madrid, Spain
  • Noelia, Martínez Jáñez
• Hospital Universitari Dexeus Grupo Quironsalud, Barcelona, Spain
  • Javier, Cortes Castan
• Complexo Hospitalario Universitario A Coruna, A Coruna, Spain
  • Silvia, Antolín Novoa
• Hospital Universitario Virgen De La Victoria, Malaga, Spain
  • María Emilia, Domínguez Recio
• Hospital Clinico Universitario De Valencia, Valencia, Spain
  • Begoña, Bermejo de las Heras
• Hospital Universitario Juan Ramon Jimenez, Huelva, Spain
  • Juan, Bayo Calero
• Institut Catala D'oncologia, L'hospitalet De Llobregat, Spain
  • Sonia, Pernas
• Hospital Clinic De Barcelona, Barcelona, Spain
  • Barbara, Adamo
• Hospital Clinico San Carlos, Madrid, Spain
  • José Ángel, García Sáenz
• University Hospital Virgen Del Rocio S.L., Sevilla, Spain
  • Manuel, Ruiz Borrego
• Istituto Europeo Di Oncologia S.r.l., Milan, Italy
  • Marco, Colleoni
• Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Candiolo, Italy
  • Vanesa, Gregorc
• Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico, Bologna, Italy
  • Claudio, Zamagni
• Careggi University Hospital, Florence, Italy
  • Icro, Meattini
• Ospedale San Raffaele S.r.l., Milan, Italy
  • Giampaolo, Bianchini
• Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Meldola, Italy
  • Ugo, De Giorgi
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
  • Ida, Paris
• Istituto Oncologico Veneto, Padova, Italy
  • Valentina, Guarneri
• Istituto Nazionale Dei Tumori, Naples, Italy
  • Michelino, De Laurentiis
• Azienda USL Toscana Centro, Prato, Italy
  • Laura, Biganzoli
• Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku, Bialystok, Poland
  • Bogumila, Czartoryska-Arlukowicz
• Instytut Msf Sp. z o.o., Lodz, Poland
  • Ewa, Kalinka
• I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka, Konin, Poland
  • Boguslawa, Karaszewska
• Uniwersyteckie Centrum Kliniczne, Gdansk, Poland
  • Jacek, Jassem
• Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warsaw, Poland
  • Zbigniew, Nowecki
• Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o., Tomaszow Mazowiecki, Poland
  • Ewa, Chmielowska
• Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie, Koszalin, Poland
  • Mariusz, Kwiatkowski
• Szpitale Pomorskie Sp. z o.o., Gdynia, Poland
  • Iwona, Danielewicz
• Rotkreuzklinikum Muenchen gGmbH, Munich, Germany
  • Michael, Braun
• Studienzentrum Onkologie Ravensburg GmbH, Ravensburg, Germany
  • Thomas, Decker
• National Center For Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany
  • Andreas, Schneeweiss
• Universitaet Leipzig, Leipzig, Germany
  • Bahriye, Aktas
• Universitaet Des Saarlandes, Homburg, Germany
  • Julia, Radosa
• Institut Universitaire Du Cancer Toulouse-Oncopole, Toulouse Cedex 9, France
  • Mony, Ung