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139 results on '"Pérez García, José Manuel"'

1. Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial

Author

Llombart-Cussac, Antonio, Prat, Aleix, Pérez-García, José Manuel, Mateos, José, Pascual, Tomás, Escrivà-de-Romani, Santiago, Stradella, Agostina, Ruiz-Borrego, Manuel, de las Heras, Begoña Bermejo, Keyaerts, Marleen, Galvan, Patricia, Brasó-Maristany, Fara, García-Mosquera, Juan José, Guiot, Thomas, Gion, María, Sampayo-Cordero, Miguel, Di Cosimo, Serena, Pérez-Escuredo, Jhudit, de Frutos, Manuel Atienza, Cortés, Javier, and Gebhart, Geraldine

Published
2024
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2. Correlation between trophoblast cell-surface antigen-2 (Trop-2) expression and pathological complete response in patients with HER2-positive early breast cancer treated with neoadjuvant docetaxel, carboplatin, trastuzumab, and pertuzumab

Author

Gion, María, García-Mosquera, Juan José, Pérez-García, José Manuel, Peg, Vicente, Ruiz-Borrego, Manuel, Stradella, Agostina, Bermejo, Begoña, Guerrero, José Antonio, López-Montero, Laura, Mancino, Mario, Rodríguez-Morató, José, Antonarelli, Gabriele, Sampayo-Cordero, Miguel, Llombart-Cussac, Antonio, and Cortés, Javier

Published
2024
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3. Impact of coadministration of proton-pump inhibitors and palbociclib in hormone receptor-positive/HER2-negative advanced breast cancer

Author

Di Cosimo, Serena, Pérez-García, José Manuel, Bellet, Meritxell, Dalenc, Florence, Gil Gil, Miguel J., Ruiz-Borrego, Manuel, Gavilá, Joaquín, Aguirre, Elena, Schmid, Peter, Marmé, Frederik, Gligorov, Joseph, Schneeweiss, Andreas, Albanell, Joan, Zamora, Pilar, Wheatley, Duncan, Martínez de Dueñas, Eduardo, Amillano, Kepa, Shimizu, Eileen, Sampayo-Cordero, Miguel, Cortés, Javier, and Llombart-Cussac, Antonio

Published
2024
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4. Olaparib plus trastuzumab in HER2-positive advanced breast cancer patients with germline BRCA1/2 mutations: The OPHELIA phase 2 study

Author

Alés-Martínez, José Enrique, Balmaña, Judith, Sánchez-Rovira, Pedro, Salvador Bofill, Francisco Javier, García Sáenz, Jose Ángel, Pimentel, Isabel, Morales, Serafín, Fernández-Abad, María, Lahuerta Martínez, Ainhara, Ferrer, Neus, Zamora, Pilar, Bermejo, Begoña, Díaz-Redondo, Tamara, López-Ceballos, María Helena, Galán, María, Pérez-Escuredo, Jhudit, Calabuig, Laura, Sampayo, Miguel, Pérez-Garcia, José Manuel, Cortés, Javier, and Llombart-Cussac, Antonio

Published
2024
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5. Preventing alpelisib-related hyperglycaemia in HR+/HER2−/PIK3CA-mutated advanced breast cancer using metformin (METALLICA): a multicentre, open-label, single-arm, phase 2 trial

Author

Llombart-Cussac, Antonio, Pérez-Garcia, José Manuel, Ruiz Borrego, Manuel, Tolosa, Pablo, Blanch, Salvador, Fernández-Ortega, Adela, Urruticoechea, Ander, Blancas, Isabel, Saura, Cristina, Rojas, Beatriz, Bermejo, Begoña, Ponce Lorenzo, José, Gion, María, Cortez-Castedo, Patricia, Llabres, Elisenda, Galve, Elena, Cueva, Juan Fernando, López, Ana, Alonso-Romero, José Luis, González-Santiago, Santiago, Martínez de Dueñas, Eduardo, Ciruelos, Eva, Martrat, Griselda, Gener, Petra, Alcalá-López, Daniel, Sampayo-Cordero, Miguel, Gómez-Peralta, Fernando, and Cortés, Javier

Published
2024
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6. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial

Author

Pérez-García, José Manuel, Cortés, Javier, Ruiz-Borrego, Manuel, Colleoni, Marco, Stradella, Agostina, Bermejo, Begoña, Dalenc, Florence, Escrivá-de-Romaní, Santiago, Calvo Martínez, Lourdes, Ribelles, Nuria, Marmé, Frederik, Cortés, Alfonso, Albacar, Cinta, Gebhart, Geraldine, Prat, Aleix, Kerrou, Khaldoun, Schmid, Peter, Braga, Sofia, Di Cosimo, Serena, Gion, Maria, Antonarelli, Gabriele, Popa, Crina, Szostak, Emilia, Alcalá-López, Daniel, Gener, Petra, Rodríguez-Morató, Jose, Mina, Leonardo, Sampayo-Cordero, Miguel, and Llombart-Cussac, Antonio

Published
2024
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7. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial

Author

Hurvitz, Sara A, Hegg, Roberto, Chung, Wei-Pang, Im, Seock-Ah, Jacot, William, Ganju, Vinod, Chiu, Joanne Wing Yan, Xu, Binghe, Hamilton, Erika, Madhusudan, Srinivasan, Iwata, Hiroji, Altintas, Sevilay, Henning, Jan-Willem, Curigliano, Giuseppe, Perez-Garcia, José Manuel, Kim, Sung-Bae, Petry, Vanessa, Huang, Chiun-Sheng, Li, Wei, Frenel, Jean-Sebastien, Antolin, Silvia, Yeo, Winnie, Bianchini, Giampaolo, Loi, Sherene, Tsurutani, Junji, Egorov, Anton, Liu, Yali, Cathcart, Jillian, Ashfaque, Shahid, and Cortés, Javier

Published
2023
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8. Ipatasertib (IPA) combined with non-taxane chemotherapy (CT) for patients (pts) with previously treated advanced triple-negative breast cancer (aTNBC): The PATHFINDER phase IIa trial.

Author

Lopez-Miranda, Elena, primary, Pérez García, José Manuel, additional, Gion, Maria, additional, Ribelles, Nuria, additional, Cortez, Patricia, additional, Alonso Romero, Jose Luis, additional, Martínez-García, María, additional, Gonzalez- Santiago, Santiago, additional, Bermejo, Begoña, additional, Morales Murillo, Serafin, additional, Carañana, Vicente, additional, Garrigós, Laia, additional, Fernández, Melissa, additional, Boix, Olga, additional, Alcalá-López, Daniel, additional, Cortes, Javier, additional, and Llombart, Antonio, additional

Published
2024
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9. Prevention of sacituzumab govitecan (SG)-related neutropenia and diarrhea in patients (pts) with triple-negative or HR+/HER2- advanced breast cancer (ABC; PRIMED): A phase 2 trial.

Author

Pérez García, José Manuel, primary, Gión, María, additional, Ruiz-Borrego, Manuel, additional, Blancas, Isabel, additional, Lopez-Miranda, Elena, additional, Blanch, Salvador, additional, Recalde, Sabela, additional, Calvo, Lourdes, additional, Gonzalez, Xavier, additional, Ancizar, Nerea, additional, Morales Murillo, Serafin, additional, Cortez, Patricia, additional, Cardona, Javier, additional, Shimizu, Eileen, additional, Guerrero, José Antonio, additional, Sampayo-Cordero, Miguel, additional, Martinez-Bueno, Alejandro, additional, Cortes, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2024
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10. Comparing 18F-FDG positron emission tomography (PET) and breast magnetic resonance imaging (MRI) to predict pathological complete response (pCR) and 3-year invasive disease-free survival (3-y iDFS) in patients (pts) with HER2+ early breast cancer (EBC): An unplanned exploratory analysis of PHERGain trial.

Author

Pérez García, José Manuel, primary, Cortes, Javier, additional, Ruiz-Borrego, Manuel, additional, Stradella, Agostina, additional, Bermejo, Begoña, additional, Escrivá-de-Romaní, Santiago, additional, Calvo, Lourdes, additional, Gebhart, Geraldine, additional, Kerrou, Khaldoun, additional, García-Mosquera, Juan José, additional, Gion, Maria, additional, Antonarelli, Gabriele, additional, López-Montero, Laura, additional, Rodríguez-Morató, José, additional, Mina, Leonardo, additional, Sampayo-Cordero, Miguel, additional, and Llombart-Cussac, Antonio, additional

Published
2024
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13. Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial.

Author

Llombart-Cussac, Antonio, Prat, Aleix, Pérez-García, José Manuel, Mateos, José, Pascual, Tomás, Escrivà-de-Romani, Santiago, Stradella, Agostina, Ruiz-Borrego, Manuel, de las Heras, Begoña Bermejo, Keyaerts, Marleen, Galvan, Patricia, Brasó-Maristany, Fara, García-Mosquera, Juan José, Guiot, Thomas, Gion, María, Sampayo-Cordero, Miguel, Di Cosimo, Serena, Pérez-Escuredo, Jhudit, de Frutos, Manuel Atienza, and Cortés, Javier

Subjects
BREAST, HER2 positive breast cancer, EARLY diagnosis, MAGNETIC resonance imaging, HER2 protein, NEOADJUVANT chemotherapy
Abstract

Background: The PHERGain study (NCT03161353) is assessing early metabolic responses to neoadjuvant treatment with trastuzumab-pertuzumab and chemotherapy de-escalation using a [18Fluorine]fluorodeoxyglucose-positron emission tomography ([18F]FDG-PET) and a pathological complete response-adapted strategy in HER2-positive (HER2+) early breast cancer (EBC). Herein, we present RESPONSE, a PHERGain substudy, where clinicopathological and molecular predictors of [18F]FDG-PET disease detection were evaluated. Methods: A total of 500 patients with HER2 + EBC screened in the PHERGain trial with a tumor size > 1.5 cm by magnetic resonance imaging (MRI) were included in the RESPONSE substudy. PET[−] criteria entailed the absence of ≥ 1 breast lesion with maximum standardized uptake value (SUVmax) ≥ 1.5 × SUVmean liver + 2 standard deviation. Among 75 PET[−] patients screened, 21 with SUVmax levels < 2.5 were randomly selected and matched with 21 PET[+] patients with SUVmax levels ≥ 2.5 based on patient characteristics associated with [18F]FDG-PET status. The association between baseline SUVmax and [18F]FDG-PET status ([−] or [+]) with clinicopathological characteristics was assessed. In addition, evaluation of stromal tumor-infiltrating lymphocytes (sTILs) and gene expression analysis using PAM50 and Vantage 3D™ Cancer Metabolism Panel were specifically compared in a matched cohort of excluded and enrolled patients based on the [18F]FDG-PET eligibility criteria. Results: Median SUVmax at baseline was 7.2 (range, 1–39.3). Among all analyzed patients, a higher SUVmax was associated with a higher tumor stage, larger tumor size, lymph node involvement, hormone receptor-negative status, higher HER2 protein expression, increased Ki67 proliferation index, and higher histological grade (p < 0.05). [18F]FDG-PET [−] criteria patients had smaller tumor size (p = 0.014) along with the absence of lymph node involvement and lower histological grade than [18F]FDG-PET [+] patients (p < 0.01). Although no difference in the levels of sTILs was found among 42 matched [18F]FDG-PET [−]/[+] criteria patients (p = 0.73), [18F]FDG-PET [−] criteria patients showed a decreased risk of recurrence (ROR) and a lower proportion of PAM50 HER2-enriched subtype than [18F]FDG-PET[+] patients (p < 0.05). Differences in the expression of genes involved in cancer metabolism were observed between [18F]FDG-PET [−] and [18F]FDG-PET[+] criteria patients. Conclusions: These results highlight the clinical, biological, and metabolic heterogeneity of HER2+ breast cancer, which may facilitate the selection of HER2+ EBC patients likely to benefit from [18F]FDG-PET imaging as a tool to guide therapy. Trial registration: Clinicaltrials.gov; NCT03161353; registration date: May 15, 2017. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial

Author

Pérez-García, José Manuel, Gebhart, Geraldine, Ruiz Borrego, Manuel, Stradella, Agostina, Bermejo, Begoña, Schmid, Peter, Marmé, Frederik, Escrivá-de-Romani, Santiago, Calvo, Lourdes, Ribelles, Nuria, Martinez, Noelia, Albacar, Cinta, Prat, Aleix, Dalenc, Florence, Kerrou, Khaldoun, Colleoni, Marco, Afonso, Noemia, Di Cosimo, Serena, Sampayo-Cordero, Miguel, Malfettone, Andrea, Cortés, Javier, and Llombart-Cussac, Antonio

Published
2021
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16. Phase II, Multicenter, Single-arm Trial of Eribulin as First-line Therapy for Patients With Aggressive Taxane-pretreated HER2-Negative Metastatic Breast Cancer: The MERIBEL Study

Author

Ortega, Vanesa, Antón, Antonio, Garau, Isabel, Afonso, Noemia, Calvo, Lourdes, Fernández, Yolanda, Martínez-García, María, Blanco, Esperanza, Zamora, Pilar, García, Mirta, Illarramendi, José Juan, Rodríguez Sánchez, César Augusto, Sampayo, Miguel, Aguirre, Elena, Pérez-García, José Manuel, Cortés, Javier, and Llombart-Cussac, Antonio

Published
2019
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17. A single-arm study design with non-inferiority and superiority time-to-event endpoints: a tool for proof-of-concept and de-intensification strategies in breast cancer

Author

Sampayo-Cordero, Miguel, primary, Miguel-Huguet, Bernat, additional, Malfettone, Andrea, additional, López-Miranda, Elena, additional, Gion, María, additional, Abad, Elena, additional, Alcalá-López, Daniel, additional, Pérez-Escuredo, Jhudit, additional, Pérez-García, José Manuel, additional, Llombart-Cussac, Antonio, additional, and Cortés, Javier, additional

Published
2023
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19. Trastuzumab and pertuzumab without chemotherapy in early-stage HER2+ breast cancer: a plain language summary of the PHERGain study

Author

Pérez-García, José Manuel, Gebhart, Geraldine, Borrego, Manuel Ruiz, Schmid, Peter, Marmé, Frederik, Prat, Aleix, Dalenc, Florence, Kerrou, Khaldoun, Colleoni, Marco, Braga, Sofía, Malfettone, Andrea, Sampayo-Cordero, Miguel, Cortés, Javier, and Llombart-Cussac, Antonio

Subjects
Adjuvant treatment of cancer, Cancer Research, Receptor, ErbB-2, Breast Neoplasms, General Medicine, Trastuzumab, HER2-positive, Neoadjuvant Therapy, de-escalation, Càncer de mama, pathologic complete response, Breast cancer, Oncology, pertuzumab, Fluorodeoxyglucose F18, Antineoplastic Combined Chemotherapy Protocols, Quality of Life, Humans, Female, early breast cancer, FDG-PET, Tractament adjuvant del càncer
Abstract

What is this summary about? This is a summary of a publication about the PHERGain study, which was published in The Lancet Oncology in May 2021. The study includes 376 women with a type of breast cancer called HER2-positive breast cancer that can be removed by surgery. In the study, researchers wanted to learn if participants could be treated with two medicines called trastuzumab and pertuzumab without the need for chemotherapy. To identify HER2-positive tumors with more sensitivity to anti-HER2 therapies, the researchers used a type of imaging called a FDG-PET scan to check how well the treatments were working. What happened in the PHERGain study? Participants took a treatment before surgery, consisting of either chemotherapy (docetaxel and carboplatin) plus trastuzumab and pertuzumab (group A) or trastuzumab and pertuzumab alone (plus hormone therapy if the tumor was hormone receptor-positive; group B). After two cycles of treatment, participants underwent a FDG-PET scan. Participants assigned to group A completed 6 cycles of treatment regardless of 18F-FDG-PET results. Participants in group B continued the same treatment until surgery if their FDG-PET scan showed the treatment was working. While participants who did not show a response started treatment with chemotherapy in addition to trastuzumab and pertuzumab. All participants then had surgery. What were the results? The results revealed that, of the participants in group B who showed a response using FDG-PET scan, 37.9% achieved a disappearance of all invasive cancer in the breast and axillary lymph nodes. This rate appears to be higher than those reported in previous studies evaluating the same treatment. These participants also had less side effects and improved overall quality of life compared with participants taking chemotherapy plus trastuzumab and pertuzumab. What do the results of the study mean? Early monitoring of how well participants respond to treatment by FDG-PET scan seems to identify participants with operable HER2-positive breast cancer who were more likely to benefit from trastuzumab and pertuzumab without the need to have chemotherapy. The PHERGain study is still ongoing and results on long-term survival are expected to be released in 2023. Clinical Trial Registration: NCT03161353 ( ClinicalTrials.gov )

Published
2022

20. Supplementary Figure S2 from Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

Author

Albanell, Joan, primary, Pérez-García, José Manuel, primary, Gil-Gil, Miguel, primary, Curigliano, Giuseppe, primary, Ruíz-Borrego, Manuel, primary, Comerma, Laura, primary, Gibert, Joan, primary, Bellet, Meritxell, primary, Bermejo, Begoña, primary, Calvo, Lourdes, primary, de la Haba, Juan, primary, Espinosa, Enrique, primary, Minisini, Alessandro Marco, primary, Quiroga, Vanesa, primary, Santaballa Bertran, Ana, primary, Mina, Leonardo, primary, Bellosillo, Beatriz, primary, Rojo, Federico, primary, Menéndez, Silvia, primary, Sampayo-Cordero, Miguel, primary, Popa, Crina, primary, Malfettone, Andrea, primary, Cortés, Javier, primary, and Llombart-Cussac, Antonio, primary

Published
2023
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21. Supplementary Tables S1-14 from Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

Author

Albanell, Joan, primary, Pérez-García, José Manuel, primary, Gil-Gil, Miguel, primary, Curigliano, Giuseppe, primary, Ruíz-Borrego, Manuel, primary, Comerma, Laura, primary, Gibert, Joan, primary, Bellet, Meritxell, primary, Bermejo, Begoña, primary, Calvo, Lourdes, primary, de la Haba, Juan, primary, Espinosa, Enrique, primary, Minisini, Alessandro Marco, primary, Quiroga, Vanesa, primary, Santaballa Bertran, Ana, primary, Mina, Leonardo, primary, Bellosillo, Beatriz, primary, Rojo, Federico, primary, Menéndez, Silvia, primary, Sampayo-Cordero, Miguel, primary, Popa, Crina, primary, Malfettone, Andrea, primary, Cortés, Javier, primary, and Llombart-Cussac, Antonio, primary

Published
2023
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23. La agricultura gallega y sus rendimientos. Un estudio evolutivo (1700-1850)

Author

Pérez García, José Manuel

Subjects
History of Spain, DP1-402, Modern history, 1453-, D204-475
Abstract

Sometemos a la consideración del lector la segunda parte de una encuesta sobre los rendimientos agrícolas, iniciada hace algunos años por nosotros. La presentación de la fuente aquí utilizada—los patrimonios eclesiásticos—, su crítica y la viabilidad de su empleo ya han ocupado nuestra atención, por lo que nos limitaremos ahora a la presentación de los resultados obtenidos. El área geográfica encuestada en este trabajo corresponde a la Galicia occidental, encuadrada desde la gran dorsal al mar y desde la cuenca del Tambre a la del Miño.

Published
1983
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24. Abstract PD13-10: PD13-10 Impact of Proton Pump Inhibitors (PPI) on Palbociclib (PAL) Outcomes in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (HR+/HER2- ABC): Exploratory Analysis of the PARSIFAL Trial

Author

Cosimo, Serena Di, primary, Pérez-García, José Manuel, additional, Ezquerra, Meritxell Bellet, additional, Dalenc, Florence, additional, Gil, Miguel Gil, additional, Borrego, Manuel Ruiz, additional, Gavilá, Joaquín, additional, Sampayo-Cordero, Miguel, additional, Aguirre, Elena, additional, Schmid, Peter, additional, Marmé, Frederik, additional, Gligorov, Joseph, additional, Schneeweiss, Andreas, additional, Albanell, Joan, additional, Zamora, Pilar, additional, Wheatley, Duncan, additional, De Dueñas, Eduardo Martínez, additional, Carañana, Vicente, additional, Amillano, Kepa, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2023
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25. Abstract GS2-02: GS2-02 Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated survival results of the randomized, phase 3 study DESTINY-Breast03

Author

Hurvitz, Sara, primary, Hegg, Roberto, additional, Chung, Wei-Pang, additional, Im, Seock-Ah, additional, Jacot, William, additional, Ganju, Vinod, additional, Chiu, Joanne Win Yang, additional, Xu, Binghe, additional, Hamilton, Erika, additional, Madhusudan, Srinivasan, additional, Iwata, Hiroji, additional, Altintas, Sevilay, additional, Henning, Jan-Willem, additional, Curigliano, Giuseppe, additional, Pérez-García, José Manuel, additional, Egorov, Anton, additional, Liu, Yali, additional, Cathcart, Jillian, additional, Ashfaque, Shahid, additional, and Cortés, Javier, additional

Published
2023
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26. Abstract PD8-02: Metformin (MET) for the prevention of Alpelisib (ALP)-related Hyperglycemia (HG) in PIK3CA-mutated, Hormone Receptor-Positive (HR[+]) HER2-Negative (HER2[-]) Advanced Breast Cancer (ABC): The METALLICA study

Author

Borrego, Manuel Ruiz, primary, Tolosa, Pablo, additional, Blanch, Salvador, additional, Fernández, Adela, additional, Urriticoechea, Ander, additional, Blancas, Isabel, additional, Saura, Cristina, additional, Rojas, Beatriz, additional, Bermejo, Begoña, additional, Ponce, Jose, additional, Gión, Maria, additional, Llabres, Elisenda, additional, Galve, Elena, additional, Cueva, Juan Fernando, additional, López, Ana, additional, Alonso-Romero, José L, additional, González-Santiago, Santiago, additional, De Dueñas, Eduardo Martínez, additional, Peralta, Fernando Gomez, additional, Ciruelos, Eva, additional, Pérez-García, José Manuel, additional, Llombart-Cussac, Antonio, additional, and Cortés, Javier, additional

Published
2023
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27. Abstract PD7-02: Trastuzumab Deruxtecan in patients with Unstable Central Nervous System Involvement from HER2-Low Advanced Breast Cancer: The DEBBRAH Trial

Author

Pérez-García, José Manuel, primary, Batista, Marta Vaz, additional, Cortez-Castedo, Patricia, additional, Borrego, Manuel Ruiz, additional, Cejalvo, Juan Miguel, additional, de la Haba-Rodríguez, Juan, additional, Garrigós, Laia, additional, Racca, Fabriccio, additional, Servitja, Sonia, additional, Blanch, Salvador, additional, Gión, Maria, additional, Nave, Mónica, additional, Fernández, Adela, additional, Martínez-Bueno, Alejandro, additional, Llombart-Cussac, Antonio, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Braga, Sofía, additional

Published
2023
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28. Abstract P4-07-29: Olaparib plus Trastuzumab in HER2[+] BRCA-Mutated Advanced Breast Cancer Patients: The OPHELIA Study

Author

Alés-Martínez, José E., primary, Balmaña, Judith, additional, Sánchez-Rovira, Pedro, additional, Bofill, Francisco Javier Salvador, additional, García-Sáenz, José Ángel, additional, Pimentel, Isabel, additional, Murillo, Serafin Morales, additional, Fernández, Adela, additional, Martínez, Ainhara Lahuerta, additional, Ferrer, Neus, additional, Zamora, Pilar, additional, Bermejo, Begoña, additional, Díaz-Redondo, Tamara, additional, Lopez-Ceballos, María Helena, additional, Galán, María, additional, Malfettone, Andrea, additional, Calabuig, Laura, additional, Sampayo-Cordero, Miguel, additional, Pérez-García, José Manuel, additional, Cortés, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2023
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29. Abstract P5-02-38: Leptin receptor (Ob-R)/leptin axis significantly modulates tumour-infiltrating lymphocytes (TILs) and PD-1 expression in early HER2+ breast cancer (BC) emerging as a new surrogate marker for immunotherapy

Author

García-Estévez, Laura, primary, Fernández, Adela, additional, Palacios, José, additional, Sampayo, Miguel, additional, Calvo, Isabel, additional, Díaz, Eva, additional, González, Marta, additional, Pérez-Míes, Belén, additional, González, Silvia, additional, Pérez-García, José Manuel, additional, Cortés, Javier, additional, and Moreno-Bueno, Gema, additional

Published
2023
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30. Consumo intensivo de alcohol en jóvenes universitarios: un estudio de seguimiento mediante neuroimagen estructural

Author

Pérez García, José Manuel, Cadaveira Mahía, Fernando, Doallo Pesado, Sonia, Universidade de Santiago de Compostela. Escola de Doutoramento Internacional (EDIUS), and Universidade de Santiago de Compostela. Programa de Doutoramento en Neurociencia e Psicoloxía Clínica

Subjects
Longitudinal, estudiantes universitarios, Investigación::32 Ciencias médicas::3201 Ciencias clínicas::320105 Psicología clínica [Materias], Investigación::61 Psicología::6113 Psicofarmacología::611303 Abuso de drogas [Materias], resonancia magnética estructural, binge drinking, Investigación::61 Psicología::6113 Psicofarmacología::611304 Efecto de las drogas [Materias]
Abstract

El binge drinking (BD) es un patrón de consumo de alcohol muy prevalente entre los estudiantes universitarios y que se ha asociado con diferentes anomalías neuropsicológicas, neuroestructurales y neurofuncionales. Sin embargo, los efectos a largo plazo del BD en el cerebro de los jóvenes y adolescentes aún no han sido suficientemente explorados. Con el objetivo principal de caracterizar las consecuencias estructurales del mantenimiento de esta forma de consumo, en esta tesis se seleccionó a un grupo de estudiantes universitarios para examinar, mediante resonancia magnética estructural, el impacto del patrón BD en tres características de la sustancia gris (i.e., el grosor cortical, el área de superficie y el volumen). La muestra final incluyó 44 estudiantes universitarios que fueron evaluados inicialmente a la edad de 18-19 años (línea base) y posteriormente tras un período de 2 años, cuando los estudiantes tenían 20-21 años (evaluación de seguimiento). Los resultados obtenidos revelaron que los binge drinkers, en comparación con los controles, presentaban alteraciones estructurales en distintas regiones corticales (i.e., la ínsula izquierda, el giro frontal rostral derecho) y subcorticales (i.e., el núcleo accumbens derecho) implicadas en el procesamiento de la recompensa, la regulación emocional y las funciones ejecutivas. Asimismo, algunas de estas anomalías fueron dependientes del sexo de los participantes y pueden reflejar un efecto diferencial del mantenimiento de un patrón BD en los procesos típicos de neuromaduración entre hombres y mujeres.

Published
2023

31. A single-arm study design with non-inferiority and superiority time-to-event endpoints: a tool for proof-of-concept and deintensification strategies in breast cancer.

Author

Sampayo-Cordero, Miguel, Miguel-Huguet, Bernat, Malfettone, Andrea, López-Miranda, Elena, Gion, María, Abad, Elena, Alcalá-López, Daniel, Pérez-Escuredo, Jhudit, Pérez-García, José Manuel, Llombart-Cussac, Antonio, and Cortés, Javier

Subjects
OVERTREATMENT of cancer, PROOF of concept, EXPERIMENTAL design, BREAST cancer, MAXIMUM likelihood statistics, DISTRIBUTION (Probability theory)
Abstract

De-escalation trials in oncology evaluate therapies that aim to improve the quality of life of patients with low-risk cancer by avoiding overtreatment. Non-inferiority randomized trials are commonly used to investigate de-intensified regimens with similar efficacy to that of standard regimens but with fewer adverse effects (ESMO evidence tier A). In cases where it is not feasible to recruit the number of patients needed for a randomized trial, single-arm prospective studies with a hypothesis of non-inferiority can be conducted as an alternative. Single-arm studies are also commonly used to evaluate novel treatment strategies (ESMO evidence tier B). A single-arm design that includes both non-inferiority and superiority primary objectives will enable the ranking of clinical activity and other parameters such as safety, pharmacokinetics, and pharmacodynamics data. Here, we describe the statistical principles and procedures to support such a strategy. The non-inferiority margin is calculated using the fixed margin method. Sample size and statistical analyses are based on the maximum likelihood method for exponential distributions. We present example analyses in metastatic and adjuvant settings to illustrate the usefulness of our methodology. We also explain its implementation with nonparametric methods. Single-arm designs with non-inferiority and superiority analyses are optimal for proof-of-concept and de-escalation studies in oncology. [ABSTRACT FROM AUTHOR]

Published
2023
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32. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial

Author

Di Cosimo, Serena, primary, Pérez-García, José Manuel, additional, Bellet, Meritxell, additional, Dalenc, Florence, additional, Gil Gil, Miguel J, additional, Ruiz Borrego, Manuel, additional, Gavilá, Joaquín, additional, Sampayo-Cordero, Miguel, additional, Aguirre, Elena, additional, Schmid, Peter, additional, Marmé, Frederik, additional, Gligorov, Joseph, additional, Schneeweiss, Andreas, additional, Albanell, Joan, additional, Zamora, Pilar, additional, Wheatley, Duncan, additional, Martínez-De Dueñas, Eduardo, additional, Carañana, Vicente, additional, Amillano, Kepa, additional, Mina, Leonardo, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2022
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33. Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

Author

Albanell, Joan, primary, Pérez-García, José Manuel, additional, Gil-Gil, Miguel, additional, Curigliano, Giuseppe, additional, Ruíz-Borrego, Manuel, additional, Comerma, Laura, additional, Gibert, Joan, additional, Bellet, Meritxell, additional, Bermejo, Begoña, additional, Calvo, Lourdes, additional, de la Haba, Juan, additional, Espinosa, Enrique, additional, Minisini, Alessandro Marco, additional, Quiroga, Vanesa, additional, Santaballa Bertran, Ana, additional, Mina, Leonardo, additional, Bellosillo, Beatriz, additional, Rojo, Federico, additional, Menéndez, Silvia, additional, Sampayo-Cordero, Miguel, additional, Popa, Crina, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2022
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34. Safety interim analysis (SIA) of atractib: A phase 2 trial of first-line (1L) atezolizumab (A) in combination with paclitaxel (P) and bevacizumab (B) in metastatic triple-negative breast cancer (mTNBC).

Author

Cortes, Maria, primary, Cortés Salgado, Alfonso, additional, Morales Murillo, Serafin, additional, Blancas, Isabel, additional, Cortez, Patricia, additional, Calvo Plaza, Isabel, additional, Diaz Fernandez, Nieves, additional, Martinez-Bueno, Alejandro, additional, Ruiz-Borrego, Manuel, additional, Blanch, Salvador, additional, Llabres, Elisenda, additional, Marmé, Frederik, additional, Schmid, Peter, additional, Guarneri, Valentina, additional, Gligorov, Joseph, additional, Pérez-García, José Manuel, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Llombart Cussac, Antonio, additional, and Cortes, Javier, additional

Published
2022
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35. Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: The DEBBRAH trial

Author

Pérez-García, José Manuel, primary, Vaz Batista, Marta, additional, Cortez, Patricia, additional, Ruiz-Borrego, Manuel, additional, Cejalvo, Juan Miguel, additional, de la Haba-Rodriguez, Juan, additional, Garrigós, Laia, additional, Racca, Fabricio, additional, Servitja, Sonia, additional, Blanch, Salvador, additional, Gion, María, additional, Nave, Monica, additional, Fernández-Abad, María, additional, Martinez-Bueno, Alejandro, additional, Llombart-Cussac, Antonio, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Braga, Sofía, additional

Published
2022
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36. Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: The DEBBRAH trial.

Author

Pérez-García, José Manuel, Batista, Marta Vaz, Cortez, Patricia, Ruiz-Borrego, Manuel, Cejalvo, Juan Miguel, de la Haba-Rodriguez, Juan, Garrigós, Laia, Racca, Fabricio, Servitja, Sonia, Blanch, Salvador, Gion, María, Nave, Monica, Fernández-Abad, María, Martinez-Bueno, Alejandro, Llombart-Cussac, Antonio, Sampayo-Cordero, Miguel, Malfettone, Andrea, Cortés, Javier, and Braga, Sofía

Published
2023
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37. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial.

Author

Cosimo, Serena Di, Pérez-García, José Manuel, Bellet, Meritxell, Dalenc, Florence, Gil, Miguel J Gil, Borrego, Manuel Ruiz, Gavilá, Joaquín, Sampayo-Cordero, Miguel, Aguirre, Elena, Schmid, Peter, Marmé, Frederik, Gligorov, Joseph, Schneeweiss, Andreas, Albanell, Joan, Zamora, Pilar, Wheatley, Duncan, Dueñas, Eduardo Martínez-De, Carañana, Vicente, Amillano, Kepa, and Mina, Leonardo

Subjects
THERAPEUTIC use of antineoplastic agents, DRUG efficacy, LETROZOLE, DRUG tolerance, VEINS, LEUCOPENIA, DIARRHEA, PULMONARY embolism, PROTEIN kinase inhibitors, AGE distribution, FULVESTRANT, NEUTROPENIA, JOINT pain, INTERSTITIAL lung diseases, ASTHENIA, THROMBOEMBOLISM, ANEMIA, PROGRESSION-free survival, FATIGUE (Physiology), HORMONE receptor positive breast cancer, PATIENT safety, DISEASE risk factors, EVALUATION
Abstract

Background Palbociclib has gained a central role in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC). Despite its manageable toxicity profile, venous thromboembolism (VTE) or interstitial lung disease (ILD)/pneumonitis may infrequently occur. Therefore, we provide a comprehensive summary of the safety and tolerability of the combination of endocrine therapy and palbociclib among patients included in the randomized phase 2 PARSIFAL study. Materials and Methods Patients with endocrine-sensitive HR+/HER2- ABC and no prior therapy in an advanced setting (n  = 486) were randomly assigned 1:1 to receive fulvestrant–palbociclib (FP) or letrozole–palbociclib (LP). Laboratory tests and the incidence of adverse events (AEs) were recorded at baseline and day 1 of each cycle. Progression-free survival (PFS) was estimated for patients with and without VTE. Results A total of 483 patients were analyzed. Neutropenia, leukopenia, anemia, asthenia, arthralgia, fatigue, and diarrhea were the most frequent AEs in both groups. Febrile neutropenia occurred in 3 (1.2%) patients of the FP group and in 1 (0.4%) patient in the LP group. Six (2.5%; 0.4% grade 3) patients in the FP group and 6 patients (2.5%; 0.4% grade 3) in the LP group experienced ILD/pneumonitis. Pulmonary embolism was reported in 12 (5.0%) patients in the FP group and 6 (2.5%) patients in the LP group. Advanced age at baseline was the only factor significantly associated with an increased risk of pulmonary embolism (P  < .01). Conclusion The PARSIFAL data confirmed the favorable safety profile of both palbociclib regimens. VTE and ILD/pneumonitis were occasionally reported, and their early detection allowed patients to continue treatment effectively without detriment to efficacy. ClinicalTrials.gov Identifier NCT02491983; https://clinicaltrials.gov/ct2/show/NCT02491983). [ABSTRACT FROM AUTHOR]

Published
2023
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38. Pembrolizumab in combination with tocilizumab in high-risk hospitalized COVID-19 patients (COPERNICO): A randomized proof-of-concept phase II study

Author

Sánchez-Conde, Matilde, primary, Vizcarra, Pilar, additional, Pérez-García, José Manuel, additional, Gion, María, additional, Martialay, María Pilar, additional, Taboada, Javier, additional, Alonso-Fernández, Alberto, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Tena, Isabel, additional, Torre, Sergio De La, additional, Llombart, Antonio, additional, and Cortes, Javier, additional

Published
2022
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39. Abstract OT1-12-07: A phase 2 study of chemotherapy de-escalation using a pathological response-guided strategy in patients with HER2-positive, low-risk early breast cancer: PHERGain-2

Author

Pérez-García, José Manuel, primary, Guerrero-Zotano, Ángel, additional, Medioni, Jacques, additional, Schneeweiss, Andreas, additional, Colleoni, Marco, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2022
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40. Abstract P5-13-30: Analysis of αβ and γδ circulating T cells in the PHERGain randomized phase 2 trial for patients with HER2-positive early breast cancer receiving neoadjuvant trastuzumab and pertuzumab without chemotherapy: LINGain

Author

Andreu-Ballester, Juan Carlos, primary, Pérez-García, José Manuel, additional, Bermejo, Begoña, additional, Carañana, Vicente, additional, Iranzo, Vega, additional, Gavilà, Joaquín, additional, Santaballa, Ana, additional, Gómez-Soler, María Carmen, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Cortes, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2022
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41. Abstract P5-16-12: Neoadjuvant letrozole plus palbociclib in patients (pts) with hormone receptor (HR)-positive/HER2-negative early breast cancer (EBC) with baseline Ki67 ≥20% and an Oncotype DX Breast Recurrence Score® result (RS) ≥18: DxCARTES

Author

Llombart-Cussac, Antonio, primary, Guerrero-Zotano, Ángel, additional, Ruiz, Manuel, additional, Bermejo, Begoña, additional, Gil-Gil, Miguel, additional, de la Haba, Juan, additional, Alba, Emilio, additional, Quiroga, Vanesa, additional, Carañana, Vicente, additional, Urruticoechea, Ander, additional, Morales, Serafín, additional, Bellet, Meritxell, additional, Antón, Antonio, additional, Pérez-García, José Manuel, additional, Fernández-Abad, María, additional, Servitja, Sonia, additional, Sánchez-Rovira, Pedro, additional, Braga, Sofia, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, and Cortes, Javier, additional

Published
2022
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42. Abstract OT2-19-06: Phase 2 study of abemaciclib in combination with endocrine therapy with or without paclitaxel induction in patients with hormone receptor-positive, HER2-negative advanced breast cancer and aggressive disease criteria: ABIGAIL

Author

Llombart-Cussac, Antonio, primary, Gligorov, Joseph, additional, Di Cosimo, Serena, additional, Albacar, Cinta, additional, Cortez, Patricia, additional, Martinez-De Dueñas, Eduardo, additional, López, Ana, additional, Carañana, Vicente, additional, Medioni, Jacques, additional, Cavanna, Luigi, additional, Cazzaniga, Marina Elena, additional, Braga, Sofia, additional, Coelho, Passos, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Pérez-García, José Manuel, additional, and Cortes, Javier, additional

Published
2022
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43. Late Breaking Abstract - Tocilizumab (T) plus pembrolizumab (P) in patients (pts) with Covid-19 pneumonia: COPERNICO

Author

Vizcarra, Pilar, primary, Sanchez, Matilde, additional, Pérez-García, José Manuel, additional, Gion, María, additional, Martialay, María Pilar, additional, Taboada, Javier, additional, De La Torre, Sergio, additional, Sampayo-Cordero, Miguel, additional, Malfettone, Andrea, additional, Llombart-Cussac, Antonio, additional, and Cortés, Javier, additional

Published
2021
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45. KEYNOTE-355: Final results from a randomized, doubleblind phase III study of first-line pembrolizumab + chemotherapy vs placebo + chemotherapy for metastatic TNBC

Author

Cortés Castán, Javier, Cescon, D. W., Rugo, H. S., Im, S. A., Yuso, M. Md., Gallardo, C., Lipatov, O., Barrios, C. H., Pérez García, José Manuel, and Schmid, P.

Subjects
Placebos, Tratamiento médico, Efectos fisiológicos, Neoplasias de la mama triple negativas, Quimioterapia, Cáncer
Abstract

Sin financiación 51.769 JCR (2021) Q1, 5/245 Oncology 8.590 SJR (2021) Q1, 2/133 Hematology No data IDR 2020 UEM

Published
2021

46. La historiografía en Demografía Histórica española durante la Edad Moderna : un estado de la cuestión

Author

Pérez García, José Manuel

Abstract

El profesor José Manuel Pérez García nos presenta en síntesis una periodificación de la evolución seguida por la Demografia Histórica en nuestro país durante las tres últimas décadas para reflexionar, posteriormente, sobre algunos de los problemas pendientes en este terreno, en especial sobre la investigación demogrdfíca en el medio urbano y la aplicación, aún escasa, del método de reconstrucción de familias a nivel general. The professor José Manuel Pérez García offer to us in a synthetic way the evolution by periods of the Historical Demography in our counrry through the three last decades, to make then a reflection about the demographical research work in the urban environment and the application -still little today, in a general level- of the method to the reconstruction of families.

Published
2021

47. The Impact of Excluding Nonrandomized Studies From Systematic Reviews in Rare Diseases: “The Example of Meta-Analyses Evaluating the Efficacy and Safety of Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis”

Author

Sampayo-Cordero, Miguel, primary, Miguel-Huguet, Bernat, additional, Malfettone, Andrea, additional, Pérez-García, José Manuel, additional, Llombart-Cussac, Antonio, additional, Cortés, Javier, additional, Pardo, Almudena, additional, and Pérez-López, Jordi, additional

Published
2021
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48. Abstract PS10-17: Palbociclib (P) in combination with fulvestrant (F) or letrozole (L) in endocrine-sensitive patients (pts) with hormone receptor (HR)[+]/HER2[-] metastatic breast cancer (MBC): detailed safety analysis from a multicenter, randomized, open-label, phase II trial (PARSIFAL)

Author

Pérez-García, José Manuel, primary, Llombart-Cussac, Antonio, additional, Bellet, Meritxell, additional, Dalenc, Florence, additional, Gil, Miguel J. Gil, additional, Borrego, Manuel Ruiz, additional, Gavilá, Joaquín, additional, Sampayo-Cordero, Miguel, additional, Aguirre, Elena, additional, Schmid, Peter, additional, Marmé, Frederik, additional, Di Cosimo, Serena, additional, Gligorov, Joseph, additional, Schneeweiss, Andreas, additional, Albanell, Joan, additional, Zamora, Pilar, additional, Wheatley, Duncan, additional, Martínez-De Dueñas, Eduardo, additional, Carañana, Vicente, additional, Amillano, Kepa, additional, Malfettone, Andrea, additional, and Cortés, Javier, additional

Published
2021
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49. Abstract PS10-27: A phase II proof-of-concept study of palbociclib (P) rechallenge in patients (pts) with hormone receptor (HR)[+]/HER2[-] metastatic breast cancer (MBC) and clinical benefit to prior P-based treatment (BIOPER)

Author

Llombart-Cussac, Antonio, primary, Cortés, Javier, additional, Paricio, Beatriz Bellosillo, additional, Gil, Miguel Gil, additional, Curigliano, Giuseppe, additional, Pérez-García, José Manuel, additional, Blesa, Laura Comerma, additional, Borrego, Manuel Ruíz, additional, Espinosa, Enrique, additional, Calvo, Lourdes, additional, Bermejo, Begoña, additional, Bellet, Meritxell, additional, Todo, Federico Rojo, additional, de la Haba, Juan, additional, Quiroga, Vanesa, additional, Minisini, Alessandro, additional, Santaballa, Ana, additional, Sampayo, Miguel, additional, Malfettone, Andrea, additional, and Albanell, Joan, additional

Published
2021
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