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1. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2 †

Author

Piccart, M, Hortobagyi, GN, Campone, M, Pritchard, KI, Lebrun, F, Ito, Y, Noguchi, S, Perez, A, Rugo, HS, Deleu, I, Burris, HA, Provencher, L, Neven, P, Gnant, M, Shtivelband, M, Wu, C, Fan, J, Feng, W, Taran, T, and Baselga, J

Subjects
Clinical Research, Cancer, Breast Cancer, Clinical Trials and Supportive Activities, Aging, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Androstadienes, Breast Neoplasms, Double-Blind Method, ErbB Receptors, Everolimus, Female, Humans, Placebos, Sirolimus, Survival Analysis, everolimus, hormone-receptor-positive breast cancer, exemestane, overall survival, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundThe BOLERO-2 study previously demonstrated that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) by more than twofold in patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs). The overall survival (OS) analysis is presented here.Patients and methodsBOLERO-2 is a phase III, double-blind, randomized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo (PBO) + EXE 25 mg/day in postmenopausal women with HR(+) advanced breast cancer with prior exposure to NSAIs. The primary end point was PFS by local investigator assessment; OS was a key secondary end point.ResultsAt the time of data cutoff (3 October 2013), 410 deaths had occurred and 13 patients remained on treatment. Median OS in patients receiving EVE + EXE was 31.0 months [95% confidence interval (CI) 28.0-34.6 months] compared with 26.6 months (95% CI 22.6-33.1 months) in patients receiving PBO + EXE (hazard ratio = 0.89; 95% CI 0.73-1.10; log-rank P = 0.14). Poststudy treatments were received by 84% of patients in the EVE + EXE arm versus 90% of patients in the PBO + EXE arm. Types of poststudy therapies were balanced across arms, except for chemotherapy (53% EVE + EXE versus 63% PBO + EXE). No new safety concerns were identified.ConclusionsIn BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001). Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting.Trial registration numberNCT00863655.

Published
2014

3. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2

Author

Rugo, HS, Pritchard, KI, Gnant, M, Noguchi, S, Piccart, M, Hortobagyi, G, Baselga, J, Perez, A, Geberth, M, Csoszi, T, Chouinard, E, Srimuninnimit, V, Puttawibul, P, Eakle, J, Feng, W, Bauly, H, El-Hashimy, M, Taran, T, and Burris, HA

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Breast Neoplasms, Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions, Everolimus, Female, Humans, Middle Aged, Neoplasm Staging, Postmenopause, Sirolimus, TOR Serine-Threonine Kinases, advanced breast cancer, everolimus, mammalian target of rapamycin, safety, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the BOLERO-2 trial, everolimus (EVE), an inhibitor of mammalian target of rapamycin, demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane (EXE) in postmenopausal women with hormone receptor-positive (HR(+)) advanced breast cancer. We report on the incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs) as well as incidence of dose modifications during the extended follow-up of this study.Patients and methodsPatients were randomized (2:1) to receive EVE 10 mg/day or placebo (PBO), with open-label EXE 25 mg/day (n = 724). The primary end point was progression-free survival. Secondary end points included overall survival, objective response rate, and safety. Safety evaluations included recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations.ResultsThe safety population comprised 720 patients (EVE + EXE, 482; PBO + EXE, 238). The median follow-up was 18 months. Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia, were generally of mild or moderate severity and occurred relatively early after treatment initiation (except pneumonitis); incidence tapered off thereafter. EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age. The median duration of dose interruption was 7 days. Discontinuation of both study drugs because of AEs was higher with EVE + EXE (9%) versus PBO + EXE (3%).ConclusionsMost EVE-associated AEs occur soon after initiation of therapy, are typically of mild or moderate severity, and are generally manageable with dose reduction and interruption. Discontinuation due to toxicity was uncommon. Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education.Trial registration numberNCT00863655.

Published
2014

4. RAD51 foci as a functional biomarker of homologous recombination repair and PARP inhibitor resistance in germline BRCA-mutated breast cancer

Author

Cruz, C., Castroviejo-Bermejo, M., Gutiérrez-Enríquez, S., Llop-Guevara, A., Ibrahim, Y.H., Gris-Oliver, A., Bonache, S., Morancho, B., Bruna, A., Rueda, O.M., Lai, Z., Polanska, U.M., Jones, G.N., Kristel, P., de Bustos, L., Guzman, M., Rodríguez, O., Grueso, J., Montalban, G., Caratú, G., Mancuso, F., Fasani, R., Jiménez, J., Howat, W.J., Dougherty, B., Vivancos, A., Nuciforo, P., Serres-Créixams, X., Rubio, I.T., Oaknin, A., Cadogan, E., Barrett, J.C., Caldas, C., Baselga, J., Saura, C., Cortés, J., Arribas, J., Jonkers, J., Díez, O., O’Connor, M.J., Balmaña, J., and Serra, V.

Published
2018
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5. The use of breast imaging for predicting response to neoadjuvant lapatinib, trastuzumab and their combination in HER2-positive breast cancer: Results from Neo-ALTTO

Author

Di Cosimo, S., Campbell, C., Azim, H.A., Jr., Galli, G., Bregni, G., Curigliano, G., Criscitiello, C., Izquierdo, M., de la Pena, L., Fumagalli, D., Fein, L., Vinholes, J., Ng, W.M.J., Colleoni, M., Ferro, A., Naume, B.J., Patel, A., Huober, J., Piccart-Gebhart, M.J., Baselga, J., and de Azambuja, E.

Published
2018
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6. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017

Author

Curigliano, G, Burstein, H.J., Winer, E.P., Gnant, M., Dubsky, P., Loibl, S., Colleoni, M., Regan, M.M., Piccart-Gebhart, M., Senn, H.-J., Thürlimann, B., André, F., Baselga, J., Bergh, J., Bonnefoi, H., Brucker, S.Y., Cardoso, F., Carey, L., Ciruelos, E., Cuzick, J., Denkert, C., Di Leo, A., Ejlertsen, B., Francis, P., Galimberti, V., Garber, J., Gulluoglu, B., Goodwin, P., Harbeck, N., Hayes, D.F., Huang, C.-S., Huober, J., Khaled, H., Jassem, J., Jiang, Z., Karlsson, P., Morrow, M., Orecchia, R., Osborne, K.C., Pagani, O., Partridge, A.H., Pritchard, K., Ro, J., Rutgers, E.J.T., Sedlmayer, F., Semiglazov, V., Shao, Z., Smith, I., Toi, M., Tutt, A., Viale, G., Watanabe, T., Whelan, T.J., and Xu, B.

Published
2017
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13. Reply to ‘The St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2017: the point of view of an International Panel of Experts in Radiation Oncology’ by Kirova et al.

Author

Dubsky, P, Curigliano, G, Burstein, H J, Winer, E P, Gnant, M, Loibl, S, Colleoni, M, Regan, M M, Piccart-Gebhart, M, Senn, H -J, Thürlimann, B, André, F, Baselga, J, Bergh, J, Bonnefoi, H, Brucker, S Y, Cardoso, F, Carey, L, Ciruelos, E, Cuzick, J, Denkert, C, Di Leo, A, Ejlertsen, B, Francis, P, Galimberti, V, Garber, J, Gulluoglu, B, Goodwin, P, Harbeck, N, Hayes, D F, Huang, C -S, Huober, J, Khaled, H, Jassem, J, Jiang, Z, Karlsson, P, Morrow, M, Orecchia, R, Osborne, K C, Pagani, O, Partridge, A H, Pritchard, K, Ro, J, Rutgers, E J T, Sedlmayer, F, Semiglazov, V, Shao, Z, Smith, I, Toi, M, Tutt, A, Viale, G, Watanabe, T, Whelan, T J, and Xu, B

Published
2018
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14. Weekly paclitaxel with trastuzumab and pertuzumab in patients with HER2-overexpressing metastatic breast cancer: overall survival and updated progression-free survival results from a phase II study

Author

Smyth, L. M., Iyengar, N. M., Chen, M. F., Popper, S. M., Patil, S., Wasserheit-Lieblich, C., Argolo, D. F., Singh, J. C., Chandarlapaty, S., Sugarman, S. M., Comen, E. A., Drullinsky, P. R., Traina, T. A., Troso-Sandoval, T., Baselga, J., Norton, L., Hudis, C. A., and Dang, C. T.

Published
2016
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20. Implementing multiplexed genotyping of non-small-cell lung cancers into routine clinical practice

Author

Sequist, L.V., Heist, R.S., Shaw, A.T., Fidias, P., Rosovsky, R., Temel, J.S., Lennes, I.T., Digumarthy, S., Waltman, B.A., Bast, E., Tammireddy, S., Morrissey, L., Muzikansky, A., Goldberg, S.B., Gainor, J., Channick, C.L., Wain, J.C., Gaissert, H., Donahue, D.M., Muniappan, A., Wright, C., Willers, H., Mathisen, D.J., Choi, N.C., Baselga, J., Lynch, T.J., Ellisen, L.W., Mino-Kenudson, M., Lanuti, M., Borger, D.R., Iafrate, A.J., Engelman, J.A., and Dias-Santagata, D.

Published
2011
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33. Degradación hidrolítica de recubrimientos polisiloxánicos de fibras de vidrio

Author

Jiménez, M., González-Benito, J., Aznar, A. J., and Baselga, J.

Subjects
Glass fibers, aminosilanes, coupling region, fluorescent labels, hydrolytic degradation, Fibras de vidrio, aminosilanos, región de acoplamiento, marcadores fluorescentes, degradación hidrolítica, Clay industries. Ceramics. Glass, TP785-869
Abstract

Aqueous solutions of three silanes: 3-aminopropyltriethoxysilane (APES), 3-aminopropylmethyldiethoxysilane (APDES), and 3-aminopropyldimethylethoxysilane (APMES), were used to cover glass fibers. The pyrenesulfonyl chloride fluorescent moiety (PSC) was chemically attached to the silanized substrate via the sulfonamide formation when the sulfonyl group of the PSC reacts with the amino residues of the coatings. It was studied the silane layer hydrolytic degradation phenomenon (pH = 7) was studied as a function of: i) temperature, and ii) coating layer type. A hydrolysis reaction mechanism of the polysiloxane bonded onto the glass fibers has been proposed and, the enthalpy change of the process was obtained (3.5 kcal/ mol). In addition, it was observed that the greater the silane functionality the faster the hydrolytic degradation.Se silanizaron fibras de vidrio mediante la utilización de disoluciones acuosas de tres silanos: 3-aminopropiltrietoxisilano (APES), 3-aminopropilmetildietoxisilano (APDES) y 3-aminopropildimetiletoxisilano (APMES). Se injertó químicamente una molécula fluorescente (cloruro de pirenosulfonilo, PSC) mediante la formación de una sulfonamida por reacción del grupo sulfonilo del PSC con los grupos amino de los recubrimientos. Se estudió el fenómeno de degradación hidrolítica del recubrimiento silano a pH = 7 en función de: i) la temperatura y ii) el tipo de recubrimiento. Se ha propuesto un mecanismo para la reacción de hidrólisis del polisiloxano enlazado a las fibras de vidrio y se ha obtenido la entalpía del proceso, cuyo valor fue de 3.5 kcal/mol. También se ha observado que a medida que la funcionalidad del silano aumenta, la degradación hidrolítica es más rápida.

Published
2000

34. Transiciones térmicas en recubrimientos polisiloxánicos de fibras de vidrio

Author

González-Benito, J., Aznar, A. J., Maçanita, A., and Baselga, J.

Subjects
Glass fibers, 3-aminopropyltriethoxisilane, coupling region, fluorescent labels, Fibras de vidrio, 3-aminopropiltrietoxisilano, región de acoplamiento, marcadores fluorescentes, Clay industries. Ceramics. Glass, TP785-869
Abstract

It was estimated the relaxation temperatures of polymeric coatings on glass fibers. In order to do this, it was carried out the fluorescent response study, as a function of temperature, of two dyes chemically bonded to the polymeric coating. The glass fibers were treated with aqueous solutions of 3-aminopropyltriethoxisilane (APES) and a 50 % mixture of APES and 3-aminopropylmethyldiethoxisilane (APDES). The fluorescent labels, pyrene-1-sulfonyl chloride (PSC) and 1-dimethylamino-5- naphtalenesulfonyl chloride (DNS), were attached to the silanized glass fibers by the formation of a stable and highly fluorescent sulfonamide conjugate (PSA and DNSA respectively). Emission spectra were recorded as a function of temperature in the range (133, 413)K. The results shown thermal transitions at low temperatures, which reflect the high flexibility of the coupling region. In addition, that transition temperature clearly depends on the structure of the polymeric coating of the glass fibers.Se realizó una estimación de las temperaturas de relajación de recubrimientos poliméricos en fibras de vidrio. Para ello, se llevó a cabo el seguimiento de la respuesta fluorescente, en función de la temperatura, de dos fluoróforos químicamente enlazados al recubrimiento polimérico. Las fibras de vidrio fueron tratadas con una disolución acuosa de 3-aminopropiltrietoxisilano (APES), y una mezcla al 50 % de APES y de 3-aminopropilmetildietoxisilano (APDES). Los marcadores fluorescentes, cloruro de pireno-1-sulfonilo (PSC) y cloruro de 1-dimetilamino-5-naftalenosulfonilo (DNS), se anclaron a las fibras de vidrio silanizadas a través de la formación de un compuesto sulfonamida estable y fluorescente (PSA y DNSA respectivamente). Se realizaron sus espectros de emisión en función de la temperatura en el intervalo (133, 413)K. Los resultados mostraron transiciones térmicas a bajas temperaturas para las muestras estudiadas indicando la alta flexibilidad de la región de acoplamiento. Además, dicha temperatura de transición depende de forma clara de la estructura del polímero que recubre a las fibras.

Published
2000

35. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial

Author

Untch, M., Gelber, R.D., Jackisch, C., Procter, M., Baselga, J., Bell, R., Cameron, D., Bari, M., Smith, I., Leyland-Jones, B., de Azambuja, E., Wermuth, P., Khasanov, R., Feng-yi, F., Constantin, C., Mayordomo, J.I., Su, C.-H., Yu, S.-Y., Lluch, A., Senkus-Konefka, E., Price, C., Haslbauer, F., Sahui, T. Suarez, Srimuninnimit, V., Colleoni, M., Coates, A.S., Piccart-Gebhart, M.J., and Goldhirsch, A.

Published
2008
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41. Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer

Author

Smyth L, Piha-Paul S, Won H, Schram A, Saura C, Loi S, Lu J, Shapiro G, Juric D, Mayer I, Arteaga C, de la Fuente M, Brufksy A, Spanggaard I, Mau-Sorensen M, Arnedos M, Moreno V, Boni V, Sohn J, Schwartzberg L, Gonzalez-Farre X, Cervantes A, Bidard F, Gorelick A, Lanman R, Nagy R, Ulaner G, Chandarlapaty S, Jhaveri K, Gavrila E, Zimel C, Selcuklu S, Melcer M, Samoila A, Cai Y, Scaltriti M, Mann G, Xu F, Eli L, Dujka M, Lalani A, Bryce R, Baselga J, Taylor B, Solit D, Meric-Bernstam F, and Hyman D

Subjects
skin and connective tissue diseases
Abstract

HER2 mutations define a subset of metastatic breast cancers with a unique mechanism of oncogenic addiction to HER2 signaling. We explored activity of the irreversible pan-HER kinase inhibitor neratinib, alone or with fulvestrant, in 81 patients with HER2-mutant metastatic breast cancer. Overall response rate was similar with or without estrogen receptor (ER) blockade. By comparison, progression-free survival and duration of response appeared longer in ER+ patients receiving combination therapy, although the study was not designed for direct comparison. Preexistent concurrent activating HER2 or HER3 alterations were associated with poor treatment outcome. Similarly, acquisition of multiple HER2-activating events, as well as gatekeeper alterations, were observed at disease progression in a high proportion of patients deriving clinical benefit from neratinib. Collectively, these data define HER2 mutations as a therapeutic target in breast cancer and suggest that coexistence of additional HER signaling alterations may promote both de novo and acquired resistance to neratinib. SIGNIFICANCE: HER2 mutations define a targetable breast cancer subset, although sensitivity to irreversible HER kinase inhibition appears to be modified by the presence of concurrent activating genomic events in the pathway. These findings have implications for potential future combinatorial approaches and broader therapeutic development for this genomically defined subset of breast cancer.

Published
2020

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