Portal de recerca
Ensayo de fase 2 de quimioterapia neoadyuvante estándar o patritumab deruxtecán (U3-1402; HER3-DXd) con o sin tratamiento endocrino para el cáncer de mama HR+/HER2- de alto riesgo: Ensayo VALENTINE.
Dades bàsiques
- Protocol:
- SOLTI-2103
- EURDRACT:
- 2022-001181-36
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
Objectius del projecte
Objetivo Principal: Evaluar la eficacia de HER3-DXd en una dosis de 5,6 mg/kg (en monoterapia o en combinación con letrozol) cuando se administra a pacientes con cáncer de mama incipiente operable como tratamiento neoadyuvante programado. Objetivos Secundarios: 1. Evaluar otros parámetros de la eficacia de HER3-DXd con o sin ET (letrozol) y quimioterapia (QT) 2. Evaluar los resultados de eficacia a largo plazo de HER3-DXd con o sin ET y LA QT. 3. Evaluar la puntuación de CelTIL en C1D21 y su capacidad para predecir la respuesta patológica en la cirugía y otros criterios de valoración de la respuesta. 4. Evaluar la capacidad de los niveles de expresión del receptor HER3 por el nivel de expresión de ARNm de IHC y ERBB3 para predecir la respuesta patológica en la cirugía. 5. Evaluar Ki67 en C1D21 y su capacidad para predecir la respuesta patológica en la cirugía y otros criterios de valoración de la respuesta. 6. Describir la seguridad y tolerabilidad de HER3-DXd con o sin ET vs QT en el entorno neoadyuvante 7. Evaluar la calidad de vida de los participantes tratados con HER3-DXd con o sin ET y QT.
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A Smart Digital Health Platform to Enable Monitoring of Quality of Life and Frailty in Older Patients with Cancer: A Mixed-Methods, Feasibility Study Protocol.
Papachristou, Nikolaos; (...); Bamidis, Panagiotis D.
Article. 10.1016/j.soncn.2023.151437. 2023
Analysis of Tumor Microenvironment Changes after Neoadjuvant Chemotherapy with or without Bevacizumab in Advanced Ovarian Cancer (GEICO-89T/MINOVA Study).
Tavira B; (...); González-Martín A
Article. 10.1158/1078-0432.CCR-23-0771. 2024
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Atezolizumab (atezo) combined with platinum-based chemotherapy (CT) and maintenance niraparib for recurrent ovarian cancer (rOC) with a platinum-free interval (TFIp) >6 months: Primary analysis of the double-blind placebo (pbo)controlled ENGOT-Ov41/GEICO 69-O/ANITA phase III trial
Martin, A. Gonzalez; (...); Selle, F.
Meeting Abstract. 10.1016/j.annonc.2023.10.031. 2023
Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial.
Gonzalez-Martin, Antonio; (...); Selle, Frederic
Article. 10.1200/JCO.24.00668. 2024
Clinical and molecular signature of survival and resistance to olaparib plus pegylated liposomal doxorubicin in platinum-resistant ovarian cancer: a stratified analysis from the phase II clinical trial ROLANDO, GEICO-1601.
Perez-Fidalgo, Jose Alejandro; (...); Gonzalez-Martin, Antonio
Article. 10.1136/ijgc-2022-004028. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Cyclin E cytoplasmatic isoform to predict outcome and benefit to capecitabine treatment in patients with HR+/HER2-metastatic breast cancer from the GEICAM/2013-02 PEARL study
Guerrero, Angel; (...); Martin, Miguel
Meeting Abstract. 2023
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Effect of aging on the human myometrium at single-cell resolution.
Punzon-Jimenez, Paula; (...); Mas, Aymara
Article. 10.1038/s41467-024-45143-z. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Hypertension as predictive factor for bevacizumab-containing first-line therapy in metastatic breast and colorectal cancer in BRECOL (GEICAM/2011-04) study.
Rodríguez-Lescure Á; (...); de la Haba-Rodriguez J
Article. 10.1007/s12094-024-03411-w. 2024
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Alamo IV registry.
Martin, Miguel; (...); Aguiar-Bujanda, David
Article. 10.1007/s10549-023-07002-1. 2023
Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study.
Kristeleit, Rebecca; (...); Subbiah, Vivek
Article. 10.1007/s10637-023-01383-2. 2023
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
Methylation and expression profiling for Sex CordStromal Tumors of the ovary subtype characterization
Roca, Carla; (...); Rivera, Barbara
Meeting Abstract. 2024
Molecular characterization of pregnancy-associated breast cancer and insights on timing from GEICAM-EMBARCAM study.
Pena-Enriquez, Regina; (...); de la Haba-Rodriguez, Juan
Article. 10.1038/s41523-025-00718-x. 2025
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
Open-label phase II clinical trial of ketoconazole as CYP17 inhibitor in metastatic or advanced non-resectable granulosa cell ovarian tumors: the GREKO (GRanulosa Et KetOconazole) trial, GETHI 2011-03.
Garcia-Donas, Jesus; (...); Grande, Enrique
Article. 10.1007/s12094-023-03085-w. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016-01).
García-Donas J; (...); Navarro P
Article. 10.1016/j.ygyno.2024.10.019. 2024
Plasma mutational burden in PIK3CA and TP53 independently predicts early progression in patients with HR+/HER2-metastatic breast cancer (MBC) enrolled in the GEICAM/2014-12 FLIPPER trial
Gustavo, Federico; (...); Albanell, Joan
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.1029. 2024
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial.
Tibau, Ariadna; (...); Albanell, Joan
Article. 10.1177/17588359221148921. 2023
Real-world safety and effectiveness of maintenance niraparib for platinum-sensitive recurrent ovarian cancer: A GEICO retrospective observational study within the Spanish expanded-access programme.
Cueva, Juan F.; (...); Gonzalez-Martin, Antonio
Article. 10.1016/j.ejca.2022.12.023. 2022
Role of the receptor for advanced glycation end products (RAGE) in blood as a potential biomarker for progression to olaparib: A post hoc analysis of patients with platinum-resistant ovarian cancer (PROC) treated in the ROLANDO-GEICO 1601 trial
Perez-Fidalgo, Jose Alejandro; (...); Gonzalez-Martin, Antonio
Meeting Abstract. 2024
Rucaparib for PARP inhibitor-pretreated ovarian cancer: A GEICO retrospective subgroup analysis from the Spanish Rucaparib Access Program.
Yubero, Alfonso; (...); Gonzalez-Martin, Antonio
Case Reports. 10.1016/j.gore.2023.101211. 2023
Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain - A GEICO study
Yubero, Alfonso; (...); Gonzalez-Martin, Antonio
Article. 10.1186/s12885-022-10191-5. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The Prognostic Significance of Tumor-Infiltrating Lymphocytes, PD-L1, BRCA Mutation Status and Tumor Mutational Burden in Early-Stage High-Grade Serous Ovarian Carcinoma-A Study by the Spanish Group for Ovarian Cancer Research (GEICO).
Pizarro, David; (...); Palacios, Jose
Article. 10.3390/ijms241311183. 2023
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Use of liquid biomarker thymidine kinase activity (TKa) to predict outcome and progression in patients with metastatic breast cancer (MBC) in the GEICAM/2014-12 FLIPPER trial
Albanell, Joan; (...); Rojo Todo, Federico Gustavo
Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.1028. 2024
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023