Magnitude of clinical benefit in trials supporting US Food and Drug Administration (FDA) accelerated approval (AA) and European Medicines Agency (EMA) conditional marketing authori... von Borrell Puy, M., Molto Valiente, C., Vokinger, K., Hwang, T., Ocana Fernandez, A., Templeton, A.J., Seruga, B., Gich Saladich, I., Barnadas, A., Amir, E., Tibau, A.

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1706P Time to full approval of novel anticancer medicines granted accelerated approval and implications for reform of the accelerated approval pathway von Hwang, T., Molto, C., Borrell Puy, M., Tibau, A.

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473P Predictive factors for drug-induced liver injury in patients with ER-positive HER2-negative metastatic breast cancer treated with first-line cyclin-dependent kinase 4/6 inhibi... von Cano, K.S. Vega, Javierre, G. Villacampa, Baselga, P. Mascaró, Mirallas, O., Adelantado, E. Zamora, Gomez, L. Sanz, Ortiz, C., Lapena, M. Cruellas, Arumi de Dios, M., Puy, M. Borrell, Filippi-Arriaga, F., Joval, L., Yaringaño, J.G., Martínez-Albaladejo, P., Buch, P.B., Esteban, P., Ruiz-Ortega, L., Manich, C. Saura, Riveiro-Barciela, M., Ezquerra, M. Bellet

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1552P Magnitude of clinical benefit of cancer drugs used in advanced soft tissue sarcomas and GIST von Teres Lleida, R., Cerda Serda, P., Martin Cullell, B., Borrell Puy, M., Bujosa, A., Gallardo Melo, P., Gavira Diaz, J., Tapia, J.C., Aguado Sorolla, M., Piedra-Cascon, A., Tibau, A., Lopez Pousa, A., Sebio Garcia, A.

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165P EPclin, OncotypeDx and Prosigna in lobular breast cancer (ILC): Is there an association with Ki67? von Leao, I.I.L., Zamora, E., Cayuela, R., Villacampa Javierre, G., Gomez Pardo, P., Arumi de Dios, M.A., Pimentel, I., Escriva de Romani, S., Ortiz Velez, C., Cruellas Lapena, M., Sanz, L., Borrell Puy, M., De La Torre, J., Espinosa-bravo, M., Gorria, T., Oliveira, M., Saura Manich, C., Peg, V., Vidal Losada, M.J., Bellet Ezquerra, M.

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1563PDMagnitude of clinical benefit in trials supporting US Food and Drug Administration (FDA) accelerated approval (AA) and European Medicines Agency (EMA) conditional marketing a... von Borrell Puy, M, Molto Valiente, C, Vokinger, K, Hwang, T, Ocana Fernandez, A, Templeton, A J, Seruga, B, Gich Saladich, I, Barnadas, A, Amir, E, Tibau, A

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1638P Are all leiomyosarcomas created equal? Clinical characteristics and experience of a single reference centre von Teres Lleida, R., Martin Cullell, B., Borrell Puy, M., Bujosa Rodríguez, A., Gallardo Melo, P.G., Molto Valiente, C., Riudavets Melia, M., Aguado Sorolla, M., Piedra Cascon, A., Tapia, J.C., Gavira Diaz, J., Orellana Fernandez, R., Bague Rosell, S., Gallardo Alcañiz, A., Lopez-Pousa, A., Serda, P. Cerda, Sebio Garcia, A.

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Clinical benefit of randomized controlled trials (RCT) supporting US Food and Drug Administration (FDA) conversion from accelerated to full approval von Puy, M. Borrell, Valiente, C. Molto, Fernandez, A. Ocana, Templeton, A., Seruga, B., Gich, I., Barnadas, A., Amir, E., Tibau, A.

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19P Tumor-associated microbiome composition and response to neoadjuvant chemotherapy (NACT) in early triple-negative breast cancer (TNBC) von Papakonstantinou, A., Napoli, S., Joval, L., Butjosa-Espin, M., Malavila, A. Mas, Puy, M. Borrell, Pimentel, I., Zamora, E., Torres, P. Gonzalez, Rodas, N. Carron, Manich, C. Saura, Seoane, J.A., Nonell, L., Nuciforo, P.G., Oliveira, M.

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27P Impact of chemotherapy (CT) use and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer (TNBC) von Barberi, V., Panet, F., Joval, L., Jaramillo, J.F. Chabla, Adelantado, E. Zamora, Pimentel, I., Puy, M. Borrell, Ezquerra, M. Bellet, Arumi de Dios, M.A., Gomez, L. Sanz, Calzado, E. Monescillo, Ortiz, C., Rezqallah Aron, M.A., Escrivá-De-Romaní, S., Lapena, M. Cruellas, Jimenez, J., Espinosa-Bravo, M., Cámara, V. Peg, Manich, C. Saura, Oliveira, M.

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265TiP SOLTI-2201 ACROSS-TROP2 trial: A phase II study to identify predictive biomarkers of sacituzumab govitecan benefit and to understand resistance mechanisms in HR+/HER2- advan... von Ciruelos, E.M., Pascual, T., Vazquez, R. Villanueva, Cejalvo, J.M., Parraga, K. Amillano, Bofill, F.J. Salvador, López-Barajas, I. Blancas, Diez, A. Ferrando, Peron, Y. Izarzugaza, Puy, M. Borrell, Fernandez-Martinez, A., Javierre, G. Villacampa, Ferrero-Cafiero, J.M., Dias, M. Paes, Salvador, F., Oliveira, M.

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155TiP A randomised phase II trial of neoadjuvant multi-agent chemotherapy (CHT) OR patritumab deruxtecan (HER3-DXd; U3-1402) +/- endocrine therapy (ET) for high-risk hormone recep... von Oliveira, M., Pascual, T., Villacampa, G., Munoz, M., Martorell, A. Perello, Lopez, M.E. Perez, Parraga, K. Amillano, Farre, X. González, Vila, C. Martinez, Ortega, P. Tolosa, Puy, M. Borrell, Vila, M. Margeli, Cejalvo, J.M., Zheteyava, Y., Sternberg, D.W., Fan, P.D., Santhanagopal, A., Bayona, R. Sanchez, Ferrero-Cafiero, J.M., Prat, A.

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115P Longterm prognostic utility of 70-gene signature by clinical and genomic risks, including Ultralow (gUL) risk patients (pts) von Gomez, L. Sanz, Zamora, E., Joval, L., Velez, C. Ortiz, Puy, M. Borrell, Arumi de Dios, M.A., Puerto, D.A. Gomez, Garces, V. Navarro, Rezqallah Aron, M.A., Cano, K.S. Vega, Escrivá-De-Romaní, S., Mirallas, O., Pimentel, I., Lapena, M. Cruellas, Villacampa, G., Oliveira, M., Manich, C. Saura, Pardo, P. Gomez, Cámara, V. Peg, Bellet-Ezquerra, M.

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250P Liver Toxicity (LT) in patients (pts) with ER-positive HER2-negative metastatic breast cancer (MBC) treated with first-line Cyclin-Dependent Kinase 4/6 inhibitors (CDKi) von Cano, K.S. Vega, Mascaro, P., Mirallas, O., Filippi-Arriaga, F., Joval, L., Zamora, E., Gomez, L. Sanz, Velez, C. Ortiz, Lapena, M. Cruellas, Arumi de Dios, M.A., Puy, M. Borrell, Esteban, P., Ruiz-Ortega, L., Buch, P.B., Yaringaño, J., Lores, G. Molina, Gomez-Puerto, D., Manich, C. Saura, Riveiro-Barciela, M., Bellet-Ezquerra, M.

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63P Ki67 values and MammaPrint (MP) genomic risk in early breast cancer: Correlation by ductal vs lobular histology von Zamora, E., Gomez, L. Sanz, Joval, L., Ortiz Velez, C., Arumi de Dios, M.A., Puy, M. Borrell, Puerto, D.A. Gomez, Leao, I.I.L., Rezqallah Aron, M.A., Garces, V. Navarro, Villacampa, G., Manich, C. Saura, Pardo, P. Gomez, Cámara, V. Peg, Bellet-Ezquerra, M.

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