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272 results on '"Ruiz-Borrego, M."'

1. A phase I dose escalation and expansion trial of the next-generation oral SERD camizestrant in women with ER-positive, HER2-negative advanced breast cancer: SERENA-1 monotherapy results

Author

Hamilton, E., Oliveira, M., Turner, N., García-Corbacho, J., Hernando, C., Ciruelos, E.M., Kabos, P., Ruiz-Borrego, M., Armstrong, A., Patel, M.R., Vaklavas, C., Twelves, C., Boni, V., Incorvati, J., Brier, T., Gibbons, L., Klinowska, T., Lindemann, J.P.O., Morrow, C.J., Sykes, A., and Baird, R.D.

Published
2024
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2. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

Zhang, Q., Xu, B., Shao, Z., Wang, X., Geng, C., Yan, X., Tong, Z., Shen, K., Yin, Y., Sun, T., Yang, J., Feng, J., Yan, M., Wang, Y., Liu, Q., Zhang, S., De Laurentiis, M., Santoro, A., Guarneri, V., Colleoni, M., Natoli, C., Cortesi, L., Placido, S., Gianni, L., Ferrau, F., Livi, L., Zambelli, A., Del Mastro, L., Tonini, G., Montemurro, F., Bianchi, G., Pedersini, R., Prete, S., Allegrini, G., Naso, G., Vici, P., Loirat, D., Mailliez, A., Priou, F., Tredan, O., Dalenc, F., Perrin, C., Gligorov, J., Timar David, M., Dohollou, N., Teixeira, L., Brocard, F., Arnaud, A., Delaloge, S., Spano, J.-P., Mansi, L., Andrade, L., Damian, F., Pedrini, J., Aleixo, S., Hegg, R., Junior, R., Reinisch, M., Schmidt, M., Wenzel, C., Grischke, E.-M., Schneeweiss, A., Just, M., Harbeck, N., Schumacher, C., Peters, U., Fischer, D., Forstbauer, H., Liersch, R., Warner, E., Bouganim, N., Doyle, C., Price Hiller, J., Vandenberg, T., Pavic, M., Robinson, A., Roldan Urgoiti, G., Califaretti, N., Alacacioglu, A., Gumus, M., Yalcin, B., Cicin, I., Kose, F., Uygun, K., Kaplan, M., Cubukcu, E., Wardley, A., Harries, M., Miles, D., Doval, D., Gupta, S., Mohapatra, P., Chatterjee, S., Ghadyalpatil, N., Singhal, M., Nag, S., Agarwal, A., Wolf, I., Gal Yam, E., Yerushalmi, R., Peretz, T., Fried, G., Ben Baruch, N., Katz, D., Hamilton, E., Kayali, F., Brufsky, A., Telli, M., Wright, G., Oyola, R., Rakowski, T., Graff, S., Tjulandin, S., Semiglazov, V., Aparicio, A., Ruiz Borrego, M., Merino, L., Guerra Martinez, J., Lopez, E., Yamashita, T., Ohtani, S., Inoue, K., Ito, Y., Niikura, N., Nakayama, T., Sagara, Y., Yanagita, Y., Kamada, Y., Kaneko, K., Kaen, D., Nervo, A., Eniu, A., Schenker, M., Priester, P., Melichar, B., Zimovjanova, M., Sormova, P., Sufliarsky, J., Kakalejcik, M., Belbaraka, R., Errihani, H., Le Than, D., Pham, D., Aravantinos, G., Papadimitriou, C., Koumakis, G., Papandreou, C., Podolski, P., Tabane, K., André, F., Cameron, D., Barrios, C., Patel, S., Patre, M., Morales, L., Patel, S.L., Kaul, M., Barata, T., and O’Shaughnessy, J.

Published
2021
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3. Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL

Author

Martin, M., Zielinski, C., Ruiz-Borrego, M., Carrasco, E., Turner, N., Ciruelos, E.M., Muñoz, M., Bermejo, B., Margeli, M., Anton, A., Kahan, Z., Csöszi, T., Casas, M.I., Murillo, L., Morales, S., Alba, E., Gal-Yam, E., Guerrero-Zotano, A., Calvo, L., de la Haba-Rodriguez, J., Ramos, M., Alvarez, I., Garcia-Palomo, A., Huang Bartlett, C., Koehler, M., Caballero, R., Corsaro, M., Huang, X., Garcia-Sáenz, J.A., Chacón, J.I., Swift, C., Thallinger, C., and Gil-Gil, M.

Published
2021
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4. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial

Author

Carcas, L., Castrellon, A., Chan, D., Cheong, K., Choi, B., Coleman, M., Conlin, A., Dichmann, R., Ellison, D., Erickson, N., Gore, I., Hansen, V., Huang, D., Hufnagel, D., Kass, F., Kendall, S.D., Kozloff, M., Lawler, W., Nahum, K.D., Pistilli, B., Reyes, E., Seeger, J., Somer, R., Chiu, E. Tan, Thomas, G., Tkaczuk, K., Vaziri, I., Wade, J., Wilkinson, M., Barcenas, C.H., Hurvitz, S.A., Di Palma, J.A., Bose, R., Chien, A.J., Iannotti, N., Marx, G., Brufsky, A., Litvak, A., Ibrahim, E., Alvarez, R.H., Ruiz-Borrego, M., Chan, N., Manalo, Y., Kellum, A., Trudeau, M., Thirlwell, M., Garcia Saenz, J., Hunt, D., Bryce, R., McCulloch, L., Rugo, H.S., Tripathy, D., and Chan, A.

Published
2020
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6. A retrospective, multicenter study of the efficacy of lapatinib plus trastuzumab in HER2-positive metastatic breast cancer patients previously treated with trastuzumab, lapatinib, or both: the Trastyvere study

Author

Gavilá, J., De La Haba, J., Bermejo, B., Rodríguez-Lescure, Á., Antón, A., Ciruelos, E., Brunet, J., Muñoz-Couselo, E., Santisteban, M., Rodríguez Sánchez, C. A., Santaballa, A., Sánchez Rovira, P., García Sáenz, J. Á., Ruiz-Borrego, M., Guerrero-Zotano, A. L., Huerta, M., Cotes-Sanchís, A., Lao Romera, J., Aguirre, E., Cortés, J., and Llombart-Cussac, A.

Published
2020
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8. A randomized adaptive phase II/III study of buparlisib, a pan-class I PI3K inhibitor, combined with paclitaxel for the treatment of HER2– advanced breast cancer (BELLE-4)

Author

Martín, M., Chan, A., Dirix, L., O’Shaughnessy, J., Hegg, R., Manikhas, A., Shtivelband, M., Krivorotko, P., Batista López, N., Campone, M., Ruiz Borrego, M., Khan, Q.J., Beck, J.T., Ramos Vázquez, M., Urban, P., Goteti, S., Di Tomaso, E., Massacesi, C., and Delaloge, S.

Published
2017
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10. Breast cancer PAM50 signature: correlation and concordance between RNA-Seq and digital multiplexed gene expression technologies in a triple negative breast cancer series

Author

Picornell, A. C., Echavarria, I., Alvarez, E., López-Tarruella, S., Jerez, Y., Hoadley, K., Parker, J. S., del Monte-Millán, M., Ramos-Medina, R., Gayarre, J., Ocaña, I., Cebollero, M., Massarrah, T., Moreno, F., García Saenz, J. A., Gómez Moreno, H., Ballesteros, A., Ruiz Borrego, M., Perou, C. M., and Martin, M.

Published
2019
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11. Correction to: Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice

Author

Blancas, I., Fontanillas, M., Conde, V., Lao, J., Martínez, E., Sotelo, M. J., Jaen, A., Bayo, J. L., Carabantes, F., Illarramendi, J. J., Gordon, M. M., Cruz, J., García-Palomo, A., Mendiola, C., Pérez-Ruiz, E., Bofill, J. S., Baena-Cañada, J. M., Jáñez, N. M., Esquerdo, G., and Ruiz-Borrego, M.

Published
2018
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12. 73P Effect of diarrheal prophylaxis or dose escalation on neratinib-associated diarrhea and tolerability in patients with HER2+ early-stage breast cancer: Final findings from the CONTROL trial

Author

Chan, A., primary, Ruiz Borrego, M., additional, Marx, G., additional, Brufsky, A., additional, Chien, A.J., additional, Thirlwell, M.P., additional, Trudeau, M.E., additional, Bose, R., additional, García Saenz, J.Á., additional, Egle, D., additional, Pistilli, B., additional, Wassermann, J., additional, Cheong, K.A., additional, Semsek, D., additional, Singer, C.F., additional, Diprimeo, D., additional, Foruzan, N., additional, McCulloch, L.M., additional, and Barcenas, C.H., additional

Published
2022
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13. 14P Gut and oral microbiota profiling in patients (pts) with hormone receptor-positive (HR+) metastatic breast cancer (MBC) receiving pembrolizumab (P) plus eribulin (E): CALADRIO

Author

Teng, N., primary, Dalby, M.J., additional, Kiu, R., additional, Robinson, T., additional, Gion Cortes, M., additional, Bermejo De Las Heras, B., additional, Perez Garcia, J.M., additional, Calvo-Martinez, L., additional, Prat, A., additional, Marquez Vazquez, R., additional, Ruiz Borrego, M., additional, de la Cruz, S., additional, Llombart Cussac, A., additional, Curigliano, G., additional, Schmid, P., additional, Mancino, M., additional, Hall, L., additional, Robinson, S., additional, Cortés, J., additional, and Malfettone, A., additional

Published
2022
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14. 92MO Neoadjuvant nivolumab (NIVO) + palbociclib (PALBO) + anastrozole (ANA) for estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) primary breast cancer (BC): CheckMate 7A8

Author

Jerusalem, G., primary, Prat, A., additional, Salgado, R.F., additional, Reinisch, M., additional, Saura, C., additional, Ruiz Borrego, M., additional, Nikolinakos, P., additional, Filian, J., additional, Ades, F., additional, Huang, N., additional, Mazzei-Abba, A., additional, and Tolaney, S.M., additional

Published
2022
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15. 93MO Optimal 18F-FDG PET/CT (FDG-PET) cut-off for pathological complete response (pCR) prediction in HER2-positive [HER2+] early breast cancer (EBC) patients (pts) treated with neoadjuvant trastuzumab (T) and pertuzumab (P) in PHERGain trial

Author

Gebhart, G., primary, Keyaerts, M., additional, Guiot, T., additional, Flamen, P., additional, Ruiz Borrego, M., additional, Stradella, A., additional, Bermejo De Las Heras, B., additional, Escriva de Romani, S., additional, Calvo-Martinez, L., additional, Ribelles Entrena, N., additional, Martinez, N., additional, Albacar Miro, C.R., additional, Colleoni, M.A., additional, Atienza de Frutos, M., additional, Sampayo-Cordero, M., additional, Cortés, J., additional, Perez Garcia, J.M., additional, and Llombart Cussac, A., additional

Published
2022
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16. 205TiP ATRACTIB: A phase II trial of first-line (1L) atezolizumab (A) in combination with paclitaxel (P) and bevacizumab (B) in metastatic triple-negative breast cancer (mTNBC)

Author

Cortés Salgado, A., primary, Perez Garcia, J.M., additional, Cortez Castedo, S.P., additional, Gion Cortes, M., additional, Morales Murillo, S., additional, Blancas López-Barajas, I., additional, Blanch, S., additional, Calvo Plaza, I., additional, Diaz Fernandez, N., additional, Marmé, F., additional, Martinez Bueno, A., additional, Taberner Bonastre, M.T., additional, De Laurentiis, M., additional, Ruiz Borrego, M., additional, Schmid, P., additional, Guarneri, V., additional, Gligorov, J., additional, Sampayo-Cordero, M., additional, Llombart Cussac, A., additional, and Cortés, J., additional

Published
2022
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17. 62P Outcomes of high-risk breast cancer (BC) patients from El Álamo IV registry and GEICAM adjuvant clinical trials

Author

Martin Jimenez, M., primary, Rodríguez-Lescure, A., additional, Andres Conejero, R., additional, Servitja Tormo, S., additional, Anton Torres, A., additional, Ruiz Borrego, M., additional, Bermejo De Las Heras, B., additional, Guerrero, A., additional, Ramos Vazquez, M., additional, Santaballa Bertran, A., additional, Munoz, M., additional, Batista, J.N., additional, Lopez-Tarruella Cobo, S., additional, Chacon Lopez-Muniz, J.I., additional, Alvarez Lopez, I., additional, Martinez del Prado, M.P., additional, Miralles, J.J., additional, Polonio, O., additional, Jara Sanchez, C., additional, and Mori de Santiago, M., additional

Published
2022
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18. 175P Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Subgroup analyses from the BYLieve study

Author

Cardoso, F., primary, Juric, D., additional, Lerebours, F., additional, Krop, I., additional, Ruiz Borrego, M., additional, Neven, P., additional, Park, Y.H., additional, Yardley, D., additional, Jhaveri, K., additional, Arce, C., additional, Gu, E., additional, Akdere, M., additional, and Rugo, H.S., additional

Published
2022
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19. Trastuzumab Deruxtecan in Patients with Central Nervous System Involvement from HER2-Positive Breast Cancer: The DEBBRAH Trial

Author

Pérez-García JM, Batista MV, Cortez P, Ruiz-Borrego M, Cejalvo JM, de la Haba-Rodriguez J, Garrigós L, Racca F, Servitja S, Blanch S, Gion M, Nave M, Fernández-Abad M, Martinez-Bueno A, Llombart-Cussac A, Sampayo-Cordero M, Malfettone A, Cortés J, and Braga S

Subjects
advanced breast cancer, brain metastases, Trastuzumab deruxtecan, HER2-positive, T-DXd
Abstract

BACKGROUND: Trastuzumab deruxtecan (T-DXd) has shown durable antitumor activity in pretreated patients with HER2-positive advanced breast cancer (ABC), but its efficacy has not yet been evaluated in patients with active brain metastases (BMs). DEBBRAH aims to assess T-DXd in patients with HER2-positive or HER2-low ABC and central nervous system involvement.; METHODS: This ongoing, five-cohort, phase II study (NCT04420598) enrolled patients with pretreated HER2-positive or HER2-low ABC with stable, untreated, or progressing BMs and/or leptomeningeal carcinomatosis. Here, we report findings from HER2-positive ABC patients with non-progressing BMs after local therapy (n=8; cohort 1), asymptomatic untreated BMs (n=4; cohort 2), or progressing BMs after local therapy (n=9; cohort 3). Patients received 5.4mg/kg T-DXd intravenously once every 21 days. The primary endpoint was 16-week progression-free survival (PFS) for cohort 1 and intracranial overall response rate (ORR-IC) for cohorts 2 and 3.; RESULTS: As of October 20, 2021, 21 patients received T-DXd. In cohort 1, 16-week PFS rate was 87.5% (95%CI, 47.3-99.7; P

Published
2022

20. Outcomes of high-risk breast cancer (BC) patients from El Alamo IV registry and GEICAM adjuvant clinical trials

Author

Martin Jimenez, M., Rodriguez-Lescure, A., Andres Conejero, R., Servitja Tormo, S., Anton Torres, A., Ruiz Borrego, M., Bermejo De Las Heras, B., Guerrero, A., Ramos Vazquez, M., Santaballa Bertran, A., Munoz, M., Batista, J. N., Lopez-Tarruella Cobo, S., Chacon Lopez-Muniz, J. I., Alvarez Lopez, I., Martinez del Prado, M. P., Miralles, J. J., Polonio, O., Jara Sanchez, C., and Mori de Santiago, M.

Published
2022

21. 266P MEN1611, a PI3K inhibitor, combined with trastuzumab (T) ± fulvestrant (F) for HER2+/PIK3CA mutant (mut) advanced or metastatic (a/m) breast cancer (BC): Safety and efficacy results from the ongoing phase Ib study (B-PRECISE-01)

Author

Piccart, M., primary, Ruiz Borrego, M., additional, Arkenau, H-T., additional, Escrivá-de-Romaní, S.I., additional, Howell, S.J., additional, Hennequin, A., additional, Jimenez-Rodriguez, B., additional, Del Conte, G., additional, Simonelli, M., additional, Palleschi, M., additional, Duhoux, F., additional, Doger De Speville Uribe, B., additional, Curigliano, G., additional, Waters, S., additional, Aftimos, P.G., additional, Wildiers, H., additional, Tosi, D., additional, Amair-Pinedo, F., additional, Pellacani, A.U.E., additional, and Laurent, D.O., additional

Published
2021
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22. 330TiP Trastuzumab deruxtecan (T-DXd; DS-8201) in HER2-positive (HER2+) and HER2-low expressing (HER-LE) metastatic breast cancer (MBC) with brain metastases (BM) and/or leptomeningeal carcinomatosis (LMC): DEBBRAH

Author

Vaz Batista, M., primary, Pérez-Garcia, J.M., additional, Llombart Cussac, A., additional, Cortez, P., additional, Ruiz Borrego, M., additional, De La Haba, J., additional, Cejalvo, J.M., additional, Racca, F., additional, Servitja, S., additional, Blanch, S., additional, Lema, L., additional, Galàn Garmaje, M., additional, Fernández-Abad, M., additional, Fernández, A., additional, Iranzo, V., additional, González-Santiago, S., additional, Gion, M., additional, Nave, M., additional, Cortés, J., additional, and Braga, S., additional

Published
2021
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23. 229MO Overall survival (OS) of palbociclib (P) plus endocrine therapy (ET) versus capecitabine (CAP) in hormone-receptor+/HER2- metastatic breast cancer (MBC) that progressed on aromatase inhibitors (AIs): Final results of the PEARL study

Author

Martin Jimenez, M., primary, Zielinski, C., additional, Ruiz-Borrego, M., additional, Carrasco, E., additional, Ciruelos, E.M., additional, Muñoz, M., additional, Bermejo, B., additional, Margeli, M., additional, Csoszi, T., additional, Anton, A., additional, Turner, N., additional, Casas, M.I., additional, Morales, S., additional, Alba, E., additional, Calvo, L., additional, De La Haba, J., additional, Ramos, M., additional, Corsaro, M., additional, Kahan, Z., additional, and Gil-Gil, M., additional

Published
2021
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24. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

Miles, D., primary, Gligorov, J., additional, André, F., additional, Cameron, D., additional, Schneeweiss, A., additional, Barrios, C., additional, Xu, B., additional, Wardley, A., additional, Kaen, D., additional, Andrade, L., additional, Semiglazov, V., additional, Reinisch, M., additional, Patel, S., additional, Patre, M., additional, Morales, L., additional, Patel, S.L., additional, Kaul, M., additional, Barata, T., additional, O’Shaughnessy, J., additional, Zhang, Q., additional, Shao, Z., additional, Wang, X., additional, Geng, C., additional, Yan, X., additional, Tong, Z., additional, Shen, K., additional, Yin, Y., additional, Sun, T., additional, Yang, J., additional, Feng, J., additional, Yan, M., additional, Wang, Y., additional, Liu, Q., additional, Zhang, S., additional, De Laurentiis, M., additional, Santoro, A., additional, Guarneri, V., additional, Colleoni, M., additional, Natoli, C., additional, Cortesi, L., additional, Placido, S., additional, Gianni, L., additional, Ferrau, F., additional, Livi, L., additional, Zambelli, A., additional, Del Mastro, L., additional, Tonini, G., additional, Montemurro, F., additional, Bianchi, G., additional, Pedersini, R., additional, Prete, S., additional, Allegrini, G., additional, Naso, G., additional, Vici, P., additional, Loirat, D., additional, Mailliez, A., additional, Priou, F., additional, Tredan, O., additional, Dalenc, F., additional, Perrin, C., additional, Timar David, M., additional, Dohollou, N., additional, Teixeira, L., additional, Brocard, F., additional, Arnaud, A., additional, Delaloge, S., additional, Spano, J.-P., additional, Mansi, L., additional, Damian, F., additional, Pedrini, J., additional, Aleixo, S., additional, Hegg, R., additional, Junior, R., additional, Schmidt, M., additional, Wenzel, C., additional, Grischke, E.-M., additional, Just, M., additional, Harbeck, N., additional, Schumacher, C., additional, Peters, U., additional, Fischer, D., additional, Forstbauer, H., additional, Liersch, R., additional, Warner, E., additional, Bouganim, N., additional, Doyle, C., additional, Price Hiller, J., additional, Vandenberg, T., additional, Pavic, M., additional, Robinson, A., additional, Roldan Urgoiti, G., additional, Califaretti, N., additional, Alacacioglu, A., additional, Gumus, M., additional, Yalcin, B., additional, Cicin, I., additional, Kose, F., additional, Uygun, K., additional, Kaplan, M., additional, Cubukcu, E., additional, Harries, M., additional, Miles, D., additional, Doval, D., additional, Gupta, S., additional, Mohapatra, P., additional, Chatterjee, S., additional, Ghadyalpatil, N., additional, Singhal, M., additional, Nag, S., additional, Agarwal, A., additional, Wolf, I., additional, Gal Yam, E., additional, Yerushalmi, R., additional, Peretz, T., additional, Fried, G., additional, Ben Baruch, N., additional, Katz, D., additional, Hamilton, E., additional, Kayali, F., additional, Brufsky, A., additional, Telli, M., additional, Wright, G., additional, Oyola, R., additional, Rakowski, T., additional, Graff, S., additional, Tjulandin, S., additional, Aparicio, A., additional, Ruiz Borrego, M., additional, Merino, L., additional, Guerra Martinez, J., additional, Lopez, E., additional, Yamashita, T., additional, Ohtani, S., additional, Inoue, K., additional, Ito, Y., additional, Niikura, N., additional, Nakayama, T., additional, Sagara, Y., additional, Yanagita, Y., additional, Kamada, Y., additional, Kaneko, K., additional, Nervo, A., additional, Eniu, A., additional, Schenker, M., additional, Priester, P., additional, Melichar, B., additional, Zimovjanova, M., additional, Sormova, P., additional, Sufliarsky, J., additional, Kakalejcik, M., additional, Belbaraka, R., additional, Errihani, H., additional, Le Than, D., additional, Pham, D., additional, Aravantinos, G., additional, Papadimitriou, C., additional, Koumakis, G., additional, Papandreou, C., additional, Podolski, P., additional, and Tabane, K., additional

Published
2021
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26. 150P Validation of a genomic assay in early-stage HER2+ breast cancer (BC) treated with trastuzumab and pertuzumab (HP): A correlative analysis from PHERGain phase II trial

Author

Llombart Cussac, A., Pérez-García, J.M., Pare Brunet, L., Villacampa Javierre, G., Brasó-Maristany, F., Gion Cortes, M., Schmid, P., Colleoni, M.A., Ruiz Borrego, M., Galván, P., Parker, J., Perou, C.M., Villagrasa Gonzalez, P., Guerrero, J.A., Sampayo-Cordero, M., Mancino, M., Prat, A., and Cortés, J.

Published
2023
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28. Original Research Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study

Author

Kahan, Z, Gil-Gil, M, Ruiz-Borrego, M, Carrasco, E, Ciruelos, E, Munoz, M, Bermejo, B, Margeli, M, Anton, A, Casas, M, Csoszi, T, Murillo, L, Morales, S, Calvo, L, Lang, I, Alba, E, de la Haba-Rodriguez, J, Ramos, M, Lopez, IA, Gal-Yam, E, Garcia-Palomo, A, Alvarez, E, Gonzalez-Santiago, S, Rodriguez, CA, Servitja, S, Corsaro, M, Rodrigalvarez, G, Zielinski, C, and Martin, M

Subjects
Endocrine therapy, CDK4, Hormone receptor-positive metastatic breast cancer, Health-related quality of life, 6 inhibitor, Palbociclib
Abstract

Background: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis compared patient-reported outcomes. Patients and methods: The PEARL quality of life (QoL) population comprised 537 patients, 268 randomised to palbociclib/ET (exemestane or fulvestrant) and 269 to capecitabine. Patients completed the European Organisation for Research and Treatment of Cancer QLQC30 and QLQ-BR23 and EQ-5D-3L questionnaires. Changes from the baseline and time to deterioration (TTD) were analysed using linear mixed-effect and stratified Cox regression models, respectively. Results: Questionnaire completion rate was high and similar between treatment arms. Significant differences were observed in the mean change in global health status (GHS)/QoL scores from the baseline to cycle 3 (2.9 for palbociclib/ET vs.-2.1 for capecitabine (95% confidence interval [CI], 1.4-8.6; P = 0.007). The median TTD in GHS/QoL was 8.3 months for palbociclib/ET versus 5.3 months for capecitabine (adjusted hazard ratio, 0.70; 95% CI, 0.55-0.89; P = 0.003). Similar improvements for palbociclib/ET were also seen for other scales as physical, role, cognitive, social functioning, fatigue, nausea/vomiting and appetite loss. No differences were observed between the treatment arms in change from the baseline in any item of the EQ-5D-L3 questionnaire as per the overall index score and visual analogue scale. Conclusion: Patients receiving palbociclib/ET experienced a significant delay in deterioration of GHS/QoL and several functional and symptom scales compared with capecitabine, providing additional evidence that palbociclib/ET is better tolerated. Trial registration number: NCT02028507 (ClinTrials.gov). EudraCT study number: 2013-003170-27. 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Published
2021

29. 129TiP Metformin (MF) in the prevention of hyperglycemia (HG) in patients (pts) with PIK3CA-mutated, hormone receptor (HR)[+]/HER2[–] advanced breast cancer (ABC) treated with alpelisib (ALP) plus fulvestrant (F): METALLICA

Author

Llombart Cussac, A., primary, Pérez-Garcia, J.M., additional, Blanch, S., additional, Tolosa, P., additional, Ruiz Borrego, M., additional, Gion Cortes, M., additional, Fernádez, A., additional, Urruticoechea, A., additional, Galve, E., additional, Cueva Banuelos, J.F., additional, Ponce, J., additional, Alonso, J.L., additional, Capelán, M., additional, Martínez, E., additional, Bermejo De Las Heras, B., additional, Rojas, B., additional, Martos, T., additional, López, A., additional, Gómez-Peralta, F., additional, and Cortés, J., additional

Published
2021
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32. The economic burden of metastatic breast cancer in Spain

Author

de las Heras B, Cajal J, Calvo E, Rodriguez J, Mata J, Anton F, Fernandez I, Rodriguez-Lescure A, Sanchez C, Ruiz-Borrego M, Remak E, Barra M, Rivero M, and Alvarez J

Subjects
stomatognathic system, skin and connective tissue diseases, neoplasms
Abstract

Objectives The study aimed to estimate the burden of metastatic breast cancer (mBC) in Spain over 5 years. Methods An incidence-based cost-of-illness model was developed in which a cohort of patients with mBC was followed from the diagnosis of metastatic disease over 5 years or death. Resource use data were collected through a physician survey conducted with 10 clinical experts in Spain. The model distinguished patients according to HER2 and hormonal receptor (HR) status, and followed the patient cohort in monthly cycles. Results The incident cohort was estimated to be 2,923 patients with mBC, consisting of 1,575 HER2-/ HR+, 520 HER2+/HR+, 324 HER2+/HR-, and 503 triple negative patients. The estimated mean survival over the 5-year time period was 2.51 years, on average, with longer survival of 3.36 years for HER2+/HR+, 2.41 years for HER2-/HR+, 2.82 years for HER2+/ HR- and shortest mean survival of 1.74 years for triple negative patients. The total costs were (sic)469,92,731 for the overall population, (sic)190,079,787 for the HER2-/ HR+, (sic)151,045,260 for the HER2+/HR+, (sic)80,827,171 for the HER2+/HR- and _47,540,512 for the triple negative subgroups over 5 years. Per patient total costs were (sic)160,642 on average, (sic)120,664 for HER2-/HR+, (sic)290,346 for HER2+/HR+, (sic)249,152 for HER2+/HR- and (sic)94,572 for triple negative patients over 5 years. Conclusions The economic burden of mBC in Spain is significant, but differs by HER2 and HR status. HER2-/ HR +patients account for the highest burden due to the prevalence of this category, but HER2+/HR +patients have the highest per patient costs.

Published
2020

34. Contextualizing pertuzumab approval in the treatment of HER2-positive breast cancer patients

Author

Cortes J, Ciruelos E, Perez-Garcia J, Albanell J, Garcia-Estevez L, Ruiz-Borrego M, Espinosa R, Gallegos I, Gonzalez S, Alvarez I, and Llombart A

Subjects
Dual blockade, Breast cancer, Pertuzumab, HER2, Trastuzumab, Adjuvant therapy
Abstract

The use of adjuvant pertuzumab in HER2-positive early-stage breast cancer has recently been approved by the EMA on the basis of data from the APHINITY trial. Accordingly, we have produced this opinion article with the aim of putting the study data in perspective against other add-on therapeutic strategies, to clarify methodological or statistical doubts about the study, and to define the population of high-risk patients with hormone receptor-negative breast cancer that we agree, in general, should be treated. With this approval, physicians must be well prepared to place the APHINITY study data in context. It is now up to each country to ratify the EMA-approved indications and to agree on reimbursement, and doctors must optimize their use based on knowledge and discussion with patients.

Published
2020

35. Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01)

Author

Lluch A, Barrios C, Torrecillas L, Ruiz-Borrego M, Bines J, Segalla J, Guerrero-Zotano A, Garcia-Saenz J, Torres R, de la Haba J, Garcia-Martinez E, Gomez H, Llombart A, Bofill J, Baena-Canada J, Barnadas A, Calvo L, Perez-Michel L, Ramos M, Fernandez I, Rodriguez-Lescure A, Cardenas J, Vinholes J, de Duenas E, Godes M, Segui M, Anton A, Lopez-Alvarez P, Moncayo J, Amorim G, Villar E, Reyes S, Sampaio C, Cardemil B, Escudero M, Bezares S, Carrasco E, Martin M, Corona J, Jara C, Toro R, Pimentel C, Hernando B, Vicente E, Zagame L, Gil M, Estevez L, Rodriguez C, de la Cruz M, Tello J, Campos S, Lomas M, Capdevile D, Campos M, Margeli M, Andres R, Tusquets I, Ballesteros A, Guerrero A, Arguello M, Rodriguez J, Munoz M, Florian J, Azevedo S, Mondragon R, Peralta J, Palomo A, Barajas L, Arcusa A, Carranza H, Garcia C, Umbria C, Ales J, Vega J, Romeo M, Valero J, Alonso J, Mathias C, Gutierrez F, Adrover E, Nunez P, Mendiola C, Cassinello J, de la Huerta A, Geicam Spanish Breast Canc Grp, CIBOMA Iberoamer Coalition Res Bre, and LACOG

Abstract

PURPOSE Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC. PATIENTS AND METHODS Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal v nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms. RESULTS Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P = .136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test P = .0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test P = .0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles. CONCLUSION This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation. (C) 2019 by American Society of Clinical Oncology

Published
2020

36. Results from PEARL study (GEICAM/2013-02_CECOG/BC.1.3.006): A phase 3 trial of Palbociclib (PAL) in combination with endocrine therapy (ET) versus Capecitabine (CAPE) in hormonal receptor (HR)-positive/human epidermal growth factor receptor (HER) 2-negative metastatic breast cancer (MBC) patients (pts) whose disease progressed on aromatase inhibitors (AIs)

Author

Martin, M, Zielinski, C, Ruiz-Borrego, M, Carrasco, E, Ciruelos, E, Munoz, M, Bermejo, B, Margeli, M, Turner, N, Casas, M, Anton, A, Csoszi, T, Corsaro, M, Murillo, L, Morales, S, Alba, E, Bartlett, CH, Koehler, M, Guerrero, A, Kahan, Z, and Gil-Gil, M

Published
2020

37. Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer

Author

Albanell, J., González, A., Ruiz-Borrego, M., Alba, E., García-Saenz, J. A., Corominas, J. M., Burgues, O., Furio, V., Rojo, A., Palacios, J., Bermejo, B., Martínez-García, M., Limon, M. L., Muñoz, A. S., Martín, M., Tusquets, I., Rojo, F., Colomer, R., Faull, I., and Lluch, A.

Published
2012
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38. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial

Author

Barcenas, C.H., primary, Hurvitz, S.A., additional, Di Palma, J.A., additional, Bose, R., additional, Chien, A.J., additional, Iannotti, N., additional, Marx, G., additional, Brufsky, A., additional, Litvak, A., additional, Ibrahim, E., additional, Alvarez, R.H., additional, Ruiz-Borrego, M., additional, Chan, N., additional, Manalo, Y., additional, Kellum, A., additional, Trudeau, M., additional, Thirlwell, M., additional, Garcia Saenz, J., additional, Hunt, D., additional, Bryce, R., additional, McCulloch, L., additional, Rugo, H.S., additional, Tripathy, D., additional, Chan, A., additional, Carcas, L., additional, Castrellon, A., additional, Chan, D., additional, Cheong, K., additional, Choi, B., additional, Coleman, M., additional, Conlin, A., additional, Dichmann, R., additional, Ellison, D., additional, Erickson, N., additional, Gore, I., additional, Hansen, V., additional, Huang, D., additional, Hufnagel, D., additional, Kass, F., additional, Kendall, S.D., additional, Kozloff, M., additional, Lawler, W., additional, Nahum, K.D., additional, Pistilli, B., additional, Reyes, E., additional, Seeger, J., additional, Somer, R., additional, Chiu, E. Tan, additional, Thomas, G., additional, Tkaczuk, K., additional, Vaziri, I., additional, Wade, J., additional, and Wilkinson, M., additional

Published
2020
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39. 101P Predictors of 18F-fluorodeoxyglucose (F) positron-emission tomography (PET)-driven disease detection in patients (pts) with HER2[+] early breast cancer (EBC). A substudy of the PHERGain trial

Author

Llombart Cussac, A., primary, Prat, A., additional, Pérez-García, J.M., additional, Mateos, J., additional, Pascual, T., additional, Escrivà-De-Romani, S., additional, Stradella, A., additional, Ruiz-Borrego, M., additional, Bermejo De Las Heras, B., additional, Keyaerts, M., additional, Sampayo-Cordero, M., additional, Malfettone, A., additional, Cortés, R., additional, Galván, P., additional, Cortés, J., additional, and Gebhart, G., additional

Published
2020
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40. 83P Impact of treatment duration of extended adjuvant therapy with neratinib in early stage HER2+ HR+ breast cancer after trastuzumab-based therapy on patient outcomes

Author

Martin Jimenez, M., primary, Gnant, M.I., additional, Ejlertsen, B., additional, Mansi, J.L., additional, Ruiz-Borrego, M., additional, Jakobsen, E.H., additional, Osborne, C.K., additional, Birhiray, R., additional, Zhang, B., additional, Wong, A., additional, Moy, B., additional, and Holmes, F.A., additional

Published
2020
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41. 143P Quality of life (QoL) with palbociclib (PAL) plus endocrine therapy (ET) versus (vs) capecitabine (CAP) in luminal metastatic breast cancer (MBC) patients (pts) in the PEARL study

Author

Kahan, Z., primary, Gil-Gil, M., additional, Ruiz-Borrego, M., additional, Carrasco, E.M., additional, Ciruelos, E.M., additional, Muñoz, M., additional, Bermejo De Las Heras, B., additional, Margeli Vila, M., additional, Anton, A., additional, Casas, M., additional, Calvo, L., additional, de la Haba, J., additional, Ramos, M., additional, Álvarez-López, I., additional, Gal-Yam, E., additional, Gautier, E., additional, Corsaro, M., additional, Rodrigálvarez, G., additional, Zielinski, C., additional, and Martin Jimenez, M., additional

Published
2020
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42. Assessment of prognostic and therapeutic factors in men with breast cancer

Author

Herrero Rivera, D., primary, Morales Herrero, M.D.R., additional, Almeida González, C., additional, Sánchez Camacho-Mejías, A., additional, Carrasco García, I., additional, Benedetti Pedroza, J., additional, Falcon Gonzalez, A., additional, Montaño Periáñez, Á, additional, Salvador Bofil, F.J., additional, and Ruiz Borrego, M., additional

Published
2019
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43. Palbociclib rechallenge in hormone receptor (HR)[+]/HER2[-] advanced breast cancer (ABC). PALMIRA trial

Author

Llombart Cussac, A., primary, Medioni, J., additional, Colleoni, M.A., additional, Ettl, J., additional, Schmid, P., additional, Macpherson, I., additional, Gligorov, J., additional, Albanell, J., additional, Bellet Ezquerra, M., additional, Fernández, A., additional, Ruiz Borrego, M., additional, Gavilá-Gregori, J., additional, Wheatley, D., additional, Zamora, P., additional, Martínez, E., additional, Sampayo, M., additional, Riva, F., additional, Malfettone, A., additional, Pérez-García, J.M., additional, and Cortés, J., additional

Published
2019
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44. Alpelisib (ALP) + endocrine therapy (ET) by last prior therapy in patients (pts) with PIK3CA-mutated hormone-receptor positive (HR+) human epidermal growth factor receptor-2-Negative (HER2–) advanced breast cancer (ABC): Additional study cohort in BYLieve

Author

Ciruelos, E., primary, Lerebours, F., additional, Ruiz Borrego, M., additional, Bachelot, T., additional, Polikoff, J., additional, Chia, S., additional, Juric, D., additional, Turner, N., additional, Ridolfi, A., additional, Sophos, N., additional, Cooper, B., additional, Thuerigen, A., additional, and Rugo, H.S., additional

Published
2019
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46. A retrospective, multicenter study of the efficacy of lapatinib plus trastuzumab in HER2-positive metastatic breast cancer patients previously treated with trastuzumab, lapatinib, or both: the Trastyvere study

Author

Gavilá, J., primary, De La Haba, J., additional, Bermejo, B., additional, Rodríguez-Lescure, Á., additional, Antón, A., additional, Ciruelos, E., additional, Brunet, J., additional, Muñoz-Couselo, E., additional, Santisteban, M., additional, Rodríguez Sánchez, C. A., additional, Santaballa, A., additional, Sánchez Rovira, P., additional, García Sáenz, J. Á., additional, Ruiz-Borrego, M., additional, Guerrero-Zotano, A. L., additional, Huerta, M., additional, Cotes-Sanchís, A., additional, Lao Romera, J., additional, Aguirre, E., additional, Cortés, J., additional, and Llombart-Cussac, A., additional

Published
2019
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48. Abstract GS2-04: Efficacy results from CIBOMA/2004-01_GEICAM/2003-11 study: A randomized phase III trial assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer

Author

Martín, M, primary, Barrios, CH, additional, Torrecillas, L, additional, Ruiz-Borrego, M, additional, Bines, J, additional, Segalla, J, additional, Ruiz, A, additional, García-Sáenz, JA, additional, Torres, R, additional, de la Haba, J, additional, García, E, additional, Gómez, HL, additional, Llombart, A, additional, Rodríguez de la Borbolla, M, additional, Baena, JM, additional, Barnadas, A, additional, Calvo, L, additional, Pérez-Michel, L, additional, Ramos, M, additional, Castellanos, J, additional, Rodríguez-Lescure, A, additional, Cárdenas, J, additional, Vinholes, J, additional, Martínez de Dueñas, E, additional, Godes, MJ, additional, Seguí, MA, additional, Antón, A, additional, López-Álvarez, P, additional, Moncayo, J, additional, Amorim, G, additional, Villar, E, additional, Reyes, S, additional, Sampaio, C, additional, Cardemil, B, additional, Escudero, MJ, additional, Bezares, S, additional, Carrasco, E, additional, and Lluch, A, additional

Published
2019
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49. Abstract OT3-06-01: Phase Ib clinical trial of coPANlisib in combination with Trastuzumab emtansine (T-DM1) in pre-treated unresectable locally advanced or metastatic HER2-positive breAst cancer (BC) “PANTHERA”-CTRIAL-IE 17-13

Author

Hassan, A, primary, Gullo, G, additional, O'Reilly, S, additional, Ruiz-Borrego, M, additional, Toomey, S, additional, Grogan, L, additional, Breathnach, O, additional, Morris, PG, additional, Walshe, JM, additional, Crown, J, additional, O'Mahony, D, additional, Falcon, A, additional, Egan, K, additional, Hernando, A, additional, Teiserskiene, A, additional, Kelly, CM, additional, Coate, L, additional, and Hennessy, BT, additional

Published
2019
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50. Abstract P2-08-06: Standardized nCounter-based determination of estrogen receptor (ER), progesterone receptor (PR) and HER2 receptor status in breast cancer

Author

Pascual, T, primary, Tsai, YS, additional, Martín, M, additional, Lluch, A, additional, Cortes, J, additional, Llombart, A, additional, Conte, P, additional, Guarneri, V, additional, Rimawi, MF, additional, Alba, E, additional, Ruiz-Borrego, M, additional, Rojo, F, additional, de la Haba, J, additional, Schiff, R, additional, Adamo, B, additional, Vidal, M, additional, Paré, L, additional, Chic, N, additional, Muñoz, M, additional, Galvan, P, additional, Gonzalez-Farre, B, additional, Brauer, HA, additional, Sullivan, A, additional, Nuciforo, P, additional, Parker, JS, additional, and Prat, A, additional

Published
2019
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