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372 results on '"Waisman J"'

1. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial

Author

Jhaveri, K., Eli, L.D., Wildiers, H., Hurvitz, S.A., Guerrero-Zotano, A., Unni, N., Brufsky, A., Park, H., Waisman, J., Yang, E.S., Spanggaard, I., Reid, S., Burkard, M.E., Vinayak, S., Prat, A., Arnedos, M., Bidard, F.-C., Loi, S., Crown, J., Bhave, M., Piha-Paul, S.A., Suga, J.M., Chia, S., Saura, C., Garcia-Saenz, J.Á., Gambardella, V., de Miguel, M.J., Gal-Yam, E.N., Raphael, A., Stemmer, S.M., Ma, C., Hanker, A.B., Ye, D., Goldman, J.W., Bose, R., Peterson, L., Bell, J.S.K., Frazier, A., DiPrimeo, D., Wong, A., Arteaga, C.L., and Solit, D.B.

Published
2023
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3. Neratinib plus fulvestrant plus trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial

Author

Jhaveri, K, Eli, LD, Wildiers, H, Hurvitz, SA, Guerrero-Zotano, A, Unni, N, Brufsky, A, Park, H, Waisman, J, Yang, ES, Spanggaard, I, Reid, S, Burkard, ME, Vinayak, S, Prat, A, Arnedos, M, Bidard, F-C, Loi, S, Crown, J, Bhave, M, Piha-Paul, SA, Suga, JM, Chia, S, Saura, C, Garcia-Saenz, JA, Gambardella, V, de Miguel, MJ, Gal-Yam, EN, Raphael, A, Stemmer, SM, Ma, C, Hanker, AB, Ye, D, Goldman, JW, Bose, R, Peterson, L, Bell, JSK, Frazier, A, Diprimeo, D, Wong, A, Arteaga, CL, Solit, DB, Jhaveri, K, Eli, LD, Wildiers, H, Hurvitz, SA, Guerrero-Zotano, A, Unni, N, Brufsky, A, Park, H, Waisman, J, Yang, ES, Spanggaard, I, Reid, S, Burkard, ME, Vinayak, S, Prat, A, Arnedos, M, Bidard, F-C, Loi, S, Crown, J, Bhave, M, Piha-Paul, SA, Suga, JM, Chia, S, Saura, C, Garcia-Saenz, JA, Gambardella, V, de Miguel, MJ, Gal-Yam, EN, Raphael, A, Stemmer, SM, Ma, C, Hanker, AB, Ye, D, Goldman, JW, Bose, R, Peterson, L, Bell, JSK, Frazier, A, Diprimeo, D, Wong, A, Arteaga, CL, and Solit, DB

Abstract

BACKGROUND: HER2 mutations are targetable alterations in patients with hormone receptor-positive (HR+) metastatic breast cancer (MBC). In the SUMMIT basket study, patients with HER2-mutant MBC received neratinib monotherapy, neratinib + fulvestrant, or neratinib + fulvestrant + trastuzumab (N + F + T). We report results from 71 patients with HR+, HER2-mutant MBC, including 21 (seven in each arm) from a randomized substudy of fulvestrant versus fulvestrant + trastuzumab (F + T) versus N + F + T. PATIENTS AND METHODS: Patients with HR+ HER2-negative MBC with activating HER2 mutation(s) and prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy received N + F + T (oral neratinib 240 mg/day with loperamide prophylaxis, intramuscular fulvestrant 500 mg on days 1, 15, and 29 of cycle 1 then q4w, intravenous trastuzumab 8 mg/kg then 6 mg/kg q3w) or F + T or fulvestrant alone. Those whose disease progressed on F + T or fulvestrant could cross-over to N + F + T. Efficacy endpoints included investigator-assessed objective response rate (ORR), clinical benefit rate (RECIST v1.1), duration of response, and progression-free survival (PFS). Plasma and/or formalin-fixed paraffin-embedded tissue samples were collected at baseline; plasma was collected during and at end of treatment. Extracted DNA was analyzed by next-generation sequencing. RESULTS: ORR for 57 N + F + T-treated patients was 39% [95% confidence interval (CI) 26% to 52%); median PFS was 8.3 months (95% CI 6.0-15.1 months). No responses occurred in fulvestrant- or F + T-treated patients; responses in patients crossing over to N + F + T supported the requirement for neratinib in the triplet. Responses were observed in patients with ductal and lobular histology, 1 or ≥1 HER2 mutations, and co-occurring HER3 mutations. Longitudinal circulating tumor DNA sequencing revealed acquisition of additional HER2 alterations, and mutations in genes including PIK3CA, enabling further precision targeting and possible re-respon

Published
2023

4. Intraductal Breast Carcinoma: Experiences from The Breast Center in Van Nuys, California

Author

Silverstein, M. J., Poller, D. N., Barth, A., Waisman, J. R., Jensen, J. A., Masetti, R., Gierson, E. D., Colburn, W. J., Lewinsky, B. S., Auerbach, S. L., Gamagami, P., Herfarth, Ch., editor, Senn, H. J., editor, Baum, M., editor, Diehl, V., editor, Gutzwiller, F., editor, Rajewsky, M. F., editor, Wannenmacher, M., editor, Senn, Hans Jörg, editor, Gelber, Richard D., editor, Goldhirsch, Aron, editor, and Thürlimann, Beat, editor

Published
1996
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6. International investigation of breast MRI: results of a multicentre study (11 sites) concerning diagnostic parameters for contrast-enhanced MRI based on 519 histopathologically correlated lesions

Author

Heywang-Köbrunner, S. H., Bick, U., Bradley Jr., W. G., Boné, B., Casselman, J., Coulthard, A., Fischer, U., Müller-Schimpfle, M., Oellinger, H., Patt, R., Teubner, J., Friedrich, M., Newstead, G., Holland, R., Schauer, A., Sickles, E. A., Tabar, L., Waisman, J., and Wernecke, K. D.

Published
2001
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10. Abstract P6-18-18: Phase I trial of eribulin and everolimus in patients with metastatic triple negative breast cancer

Author

Yuan, Y, primary, Yost, S, additional, Blanchard, S, additional, Yin, H, additional, Li, M, additional, Robinson, K, additional, Tang, A, additional, Martinez, N, additional, Leong, L, additional, Somlo, G, additional, Tank Patel, N, additional, Waisman, J, additional, Portnow, J, additional, Hurria, A, additional, Luu, T-H, additional, and Mortimer, J, additional

Published
2019
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12. Abstract P1-15-07: Phase II trial of neoadjuvant carboplatin and nab-paclitaxel in patients with locally advanced triple negative breast cancer

Author

Yuan, Y, primary, Frankel, P, additional, Li, M, additional, Kruper, L, additional, Jones, V, additional, Treece, T, additional, Waisman, J, additional, Yim, J, additional, Tumyan, L, additional, Schmolze, D, additional, Hurria, A, additional, Yeon, C, additional, Mortimer, J, additional, and Somlo, G, additional

Published
2019
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14. Abstract OT1-05-02: A phase II clinical trial of the combination of pembrolizumab and selective androgen receptor modulator GTx-024 in patients with advanced androgen receptor positive triple negative breast cancer

Author

Yuan, Y, primary, Frankel, P, additional, Synold, T, additional, Lee, P, additional, Yost, S, additional, Martinez, N, additional, Tang, A, additional, Mendez, B, additional, Schmolze, D, additional, Apple, S, additional, Hurria, A, additional, Waisman, J, additional, Somlo, G, additional, Tank, N, additional, Sedrak, M, additional, and Mortimer, J, additional

Published
2018
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15. Abstract P6-15-07: Not presented

Author

Somlo, G, primary, Waisman, J, additional, Yuan, Y, additional, Li, M, additional, Kruper, L, additional, Jones, V, additional, Treece, T, additional, Frankel, P, additional, Yim, J, additional, Tumyan, L, additional, Schmolze, D, additional, Menghi, F, additional, Liu, ET, additional, Hurria, A, additional, Yeon, C, additional, and Mortimer, J, additional

Published
2018
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16. Abstract P1-08-04: Not presented

Author

Somlo, G, primary, Yuan, Y, additional, Waisman, J, additional, Yeon, C, additional, Frankel, P, additional, Hou, W, additional, Hurria, A, additional, Tank, N, additional, Sedrak, M, additional, Synold, T, additional, Mortimer, J, additional, and Lee, P, additional

Published
2018
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19. Abstract P4-21-35: Phase II trial of pertuzumab, trastuzumab, and nab-paclitaxel in patients (pts) with HER2 overexpressing (HER2+) locally advanced or inflammatory breast cancer (LABC) or untreated stage IV metastatic breast cancer (MBC)

Author

Somlo, G, primary, Frankel, P, additional, Yeon, C, additional, Yuan, Y, additional, Yim, J, additional, Kruper, L, additional, Taylor, L, additional, Mortimer, J, additional, Waisman, J, additional, Jones, V, additional, Vito, C, additional, Paz, B, additional, Huria, A, additional, Li, D, additional, Gaal, C, additional, Tong, T, additional, and Tumyan, L, additional

Published
2017
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20. Abstract P6-07-13: Association of pre-chemotherapy peripheral blood pro-inflammatory (IL-6, CRP) and coagulation (D-dimer) markers with chemotherapy toxicity in women with breast cancer

Author

Yuan, Y, primary, Vora, N, additional, Sun, C, additional, Li, D, additional, Mortimer, J, additional, Luu, T-h, additional, Somlo, G, additional, Waisman, J, additional, Chao, J, additional, Katheria, V, additional, Synold, T, additional, Tran, V, additional, Mi, S, additional, Levi, A, additional, Yost, S, additional, Arsenyan, A, additional, Choi, J, additional, Zavala, L, additional, and Hurria, A, additional

Published
2017
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24. Abstract P1-14-10: Phase II trial of neoadjuvant chemotherapy with carboplatin and nab-paclitaxel in patients with triple negative locally advanced and inflammatory breast cancer

Author

Somlo, G, primary, Chung, S, additional, Frankel, P, additional, Hurria, A, additional, Koehler, S, additional, Kruper, L, additional, Mortimer, JE, additional, Paz, B, additional, Robinson, K, additional, Taylor, L, additional, Vito, C, additional, Waisman, J, additional, Yeon, C, additional, Yim, J, additional, Yuan, Y, additional, and Tong, T, additional

Published
2016
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43. International investigation of breast MRI: results of a multicentre study(11 sites) concerning diagnostic parameters for contrast-enhanced MRIbased on 519 histopathologically correlated lesions.

Author

Heywang-Kobrunner, SH, Bick, U, Bradley WG, Jr, Bone, B, Casselman, J, Coulthard, A, Fischer, U, Muller-Schimpfle, M, Oellinger, H, Patt, R, Teubner, J, Friedrich, M, Newstead, G, Holland, R, Schauer, A, Sickles, EA, Tabar, L, Waisman, J, Wernecke, KD, Heywang-Kobrunner, SH, Bick, U, Bradley WG, Jr, Bone, B, Casselman, J, Coulthard, A, Fischer, U, Muller-Schimpfle, M, Oellinger, H, Patt, R, Teubner, J, Friedrich, M, Newstead, G, Holland, R, Schauer, A, Sickles, EA, Tabar, L, Waisman, J, and Wernecke, KD

Published
2001

44. International investigation of breast MRI: results of a multicentre study (11 sites) concerning diagnostic parameters for contrast-enhanced MRI based on 519 histopathologically correlated lesions.

Author

Heywang-Köbrunner, S.H., Bick, U., Bradley, W.G., Bone, B., Casselman, J.W., Coulthard, A., Fischer, U., Muller-Schimpfle, M., Oellinger, H., Patt, R., Teubner, J., Friedrich, M., Newstead, G., Holland, R., Schauer, A., Sickles, E.A., Tabar, L., Waisman, J., Wernecke, K.D., Heywang-Köbrunner, S.H., Bick, U., Bradley, W.G., Bone, B., Casselman, J.W., Coulthard, A., Fischer, U., Muller-Schimpfle, M., Oellinger, H., Patt, R., Teubner, J., Friedrich, M., Newstead, G., Holland, R., Schauer, A., Sickles, E.A., Tabar, L., Waisman, J., and Wernecke, K.D.

Abstract

Item does not contain fulltext, A multicentre study was undertaken to provide fundamentals for improved standardization and optimized interpretation guidelines of dynamic contrast-enhanced MRI. Only patients scheduled for biopsy of a clinical or imaging abnormality were included. They underwent standardized dynamic MRI on Siemens 1.0 (163 valid lesions > or = 5 mm) or 1.5 T (395 valid lesions > or = 5 mm) using 3D fast low-angle shot (FLASH; 87 s) before and five times after standardized bolus of 0.2 mmol Gd-DTPA/kg. One-Tesla and 1.5 T data were analysed separately using a discriminant analysis. Only histologically correlated lesions entered the statistical evaluation. Histopathology and imaging were correlated in retrospect and in open. The best results were achieved by combining up to five wash-in or wash-out parameters. Different weighting of false-negative vs false-positive calls allowed formulation of a statistically based interpretation scheme yielding optimized rules for the highest possible sensitivity (specificity 30%), for moderate (50%) or high (64-71%) specificity. The sensitivities obtained at the above specificity levels were better at 1.0 T (98, 97, or 96%) than at 1.5 T (96, 93, 86%). Using a widely available standardized MR technique definition of statistically founded interpretation rules is possible. Choice of an optimum interpretation rule may vary with the clinical question. Prospective testing remains necessary. Differences of 1.0 and 1.5 T are not statistically significant but may be due to pulse sequences.

Published
2001

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