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235 results on '"Gradishar, William J."'

1. A randomized phase III double-blind placebo-controlled trial of first-line chemotherapy and trastuzumab with or without bevacizumab for patients with HER2/neu-positive metastatic breast cancer: a trial of the ECOG-ACRIN Cancer Research Group (E1105)

Author

Mezzanotte-Sharpe, Jessica, ONeill, Anne, Mayer, Ingrid A., Arteaga, Carlos L., Yang, Ximing J., Wagner, Lynne I., Cella, David, Meropol, Neal J., Alpaugh, R. Katherine, Saphner, Thomas J., Swaney, Robert E., Hoelzer, Karen L., Gradishar, William J., Abramson, Vandana G., Sundaram, P. Kothai, Jilani, Shamim Z., Perez, Edith A., Lin, Nancy U., Jahanzeb, Mohammad, Wolff, Antonio C., Sledge, George W., and Reid, Sonya A.

Published
2024
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2. Identifying homologous recombination deficiency in breast cancer: genomic instability score distributions differ among breast cancer subtypes

Author

Lenz, Lauren, Neff, Chris, Solimeno, Cara, Cogan, Elizabeth S., Abramson, Vandana G., Boughey, Judy C., Falkson, Carla, Goetz, Matthew P., Ford, James M., Gradishar, William J., Jankowitz, Rachel C., Kaklamani, Virginia G., Marcom, P. Kelly, Richardson, Andrea L., Storniolo, Anna Maria, Tung, Nadine M., Vinayak, Shaveta, Hodgson, Darren R., Lai, Zhongwu, Dearden, Simon, Hennessy, Bryan T., Mayer, Erica L., Mills, Gordon B., Slavin, Thomas P., Gutin, Alexander, Connolly, Roisin M., Telli, Melinda L., Stearns, Vered, Lanchbury, Jerry S., and Timms, Kirsten M.

Published
2023
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3. Margetuximab Versus Trastuzumab in Patients With Previously Treated HER2-Positive Advanced Breast Cancer (SOPHIA): Final Overall Survival Results From a Randomized Phase 3 Trial

Author

Rugo, Hope S, Im, Seock-Ah, Cardoso, Fatima, Cortes, Javier, Curigliano, Giuseppe, Musolino, Antonino, Pegram, Mark D, Bachelot, Thomas, Wright, Gail S, Saura, Cristina, Escrivá-de-Romaní, Santiago, De Laurentiis, Michelino, Schwartz, Gary N, Pluard, Timothy J, Ricci, Francesco, Gwin, William R, Levy, Christelle, Brown-Glaberman, Ursa, Ferrero, Jean-Marc, de Boer, Maaike, Kim, Sung-Bae, Petráková, Katarína, Yardley, Denise A, Freedman, Orit, Jakobsen, Erik H, Gal-Yam, Einav Nili, Yerushalmi, Rinat, Fasching, Peter A, Kaufman, Peter A, Ashley, Emily J, Perez-Olle, Raul, Hong, Shengyan, Rosales, Minori Koshiji, Gradishar, William J, and Group, on behalf of the SOPHIA Study

Subjects
Cancer, Clinical Research, Breast Cancer, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Humans, Female, Trastuzumab, Breast Neoplasms, Receptor, ErbB-2, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, SOPHIA Study Group, Receptor, erbB-2, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Final overall survival (OS) in SOPHIA (ClinicalTrials.gov identifier: NCT02492711), a study of margetuximab versus trastuzumab, both with chemotherapy, in patients with previously treated human epidermal growth factor receptor 2-positive advanced breast cancer, is reported with updated safety. Overall, 536 patients in the intention-to-treat population were randomly assigned to margetuximab (15 mg/kg intravenously once every 3 weeks; n = 266) plus chemotherapy or trastuzumab (6 mg/kg intravenously once every 3 weeks after a loading dose of 8 mg/kg; n = 270) plus chemotherapy. Primary end points were progression-free survival, previously reported, and OS. Final OS analysis was triggered by 385 prespecified events. The median OS was 21.6 months (95% CI, 18.89 to 25.07) with margetuximab versus 21.9 months (95% CI, 18.69 to 24.18) with trastuzumab (hazard ratio [HR], 0.95; 95% CI, 0.77 to 1.17; P = .620). Preplanned, exploratory analysis of CD16A genotyping suggested a possible improvement in OS for margetuximab in CD16A-158FF patients versus trastuzumab (median OS, 23.6 v 19.2 months; HR, 0.72; 95% CI, 0.52 to 1.00) and a possible improvement in OS for trastuzumab in CD16A-158VV patients versus margetuximab (median OS, 31.1 v 22.0 months; HR, 1.77; 95% CI, 1.01 to 3.12). Margetuximab safety was comparable with trastuzumab. Final overall OS analysis did not demonstrate margetuximab advantage over trastuzumab. Margetuximab studies in patients with human epidermal growth factor receptor 2-positive breast cancer with different CD16A allelic variants are warranted.

Published
2023

4. Pharmacological suppression of the OTUD4/CD73 proteolytic axis revives antitumor immunity against immune-suppressive breast cancers

Author

Zhu, Yueming, Banerjee, Anupam, Xie, Ping, Ivanov, Andrey A., Uddin, Amad, Jiao, Qiao, Chi, Junlong Jack, Zeng, Lidan, Lee, Ji Young, Xue, Yifan, Lu, Xinghua, Cristofanilli, Massimo, Gradishar, William J., Henry, Curtis J., Gillespie, Theresa W., Bhave, Manali Ajay, Kalinsky, Kevin, Fu, Haian, Bahar, Ivet, Zhang, Bin, and Wan, Yong

Subjects
Proteolysis -- Analysis -- Health aspects, Immunosuppression -- Analysis -- Health aspects, Health care industry
Abstract

Despite widespread utilization of immunotherapy, treating immune-cold tumors remains a challenge. Multiomic analyses and experimental validation identified the OTUD4/CD73 proteolytic axis as a promising target in treating immune-suppressive triple negative breast cancer (TNBC). Mechanistically, deubiquitylation of CD73 by OTUD4 counteracted its ubiquitylation by TRIM21, resulting in CD73 stabilization inhibiting tumor immune responses. We further demonstrated the importance of TGF-[beta] signaling for orchestrating the OTUD4/CD73 proteolytic axis within tumor cells. Spatial transcriptomics profiling discovered spatially resolved features of interacting malignant and immune cells pertaining to expression levels of OTUD4 and CD73. In addition, ST80, a newly developed inhibitor, specifically disrupted proteolytic interaction between CD73 and OTUD4, leading to reinvigoration of cytotoxic [CD8.sup.+] T cell activities. In preclinical models of TNBC, ST80 treatment sensitized refractory tumors to anti-PD-LI therapy. Collectively, our findings uncover what we believe to be a novel strategy for targeting the immunosuppressive OTUD4/CD73 proteolytic axis in treating immune-suppressive breast cancers with the inhibitor ST80., Introduction Despite the widespread utilization of immunotherapy, the poor clinical response by immune-suppressive tumors is an emerging challenge in use of current immune checkpoint inhibitors. Triple negative breast cancers (TNBCs) [...]

Published
2024
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5. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7)

Author

Cardoso, Fatima, Paluch-Shimon, Shani, Schumacher-Wulf, Eva, Matos, Leonor, Gelmon, Karen, Aapro, Matti S., Bajpai, Jyoti, Barrios, Carlos H., Bergh, Jonas, Bergsten-Nordström, Elizabeth, Biganzoli, Laura, Cardoso, Maria João, Carey, Lisa A., Chavez-MacGregor, Mariana, Chidebe, Runcie, Cortés, Javier, Curigliano, Giuseppe, Dent, Rebecca A., El Saghir, Nagi S., Eniu, Alexandru, Fallowfield, Lesley, Francis, Prudence A., Franco Millan, Sandra X., Gilchrist, Jenny, Gligorov, Joseph, Gradishar, William J., Haidinger, Renate, Harbeck, Nadia, Hu, Xichun, Kaur, Ranjit, Kiely, Belinda, Kim, Sung-Bae, Koppikar, Smruti, Kuper-Hommel, Marion J.J., Lecouvet, Frédéric E., Mason, Ginny, Mertz, Shirley A., Mueller, Volkmar, Myerson, Claire, Neciosup, Silvia, Offersen, Birgitte V., Ohno, Shinji, Pagani, Olivia, Partridge, Ann H., Penault-Llorca, Frédérique, Prat, Aleix, Rugo, Hope S., Senkus, Elzbieta, Sledge, George W., Swain, Sandra M., Thomssen, Christoph, Vorobiof, Daniel A., Vuylsteke, Peter, Wiseman, Theresa, Xu, Binghe, Costa, Alberto, Norton, Larry, and Winer, Eric P.

Published
2024
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6. Interplay between ESR1/PIK3CA codon variants, oncogenic pathway alterations and clinical phenotype in patients with metastatic breast cancer (MBC): comprehensive circulating tumor DNA (ctDNA) analysis

Author

Gerratana, Lorenzo, Davis, Andrew A., Velimirovic, Marko, Clifton, Katherine, Hensing, Whitney L., Shah, Ami N., Dai, Charles S., Reduzzi, Carolina, D’Amico, Paolo, Wehbe, Firas, Medford, Arielle, Wander, Seth A., Gradishar, William J., Behdad, Amir, Puglisi, Fabio, Ma, Cynthia X., Bardia, Aditya, and Cristofanilli, Massimo

Published
2023
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7. Role of Fcγ receptors in HER2-targeted breast cancer therapy

Author

Musolino, Antonino, Gradishar, William J, Rugo, Hope S, Nordstrom, Jeffrey L, Rock, Edwin P, Arnaldez, Fernanda, and Pegram, Mark D

Subjects
Vaccine Related, Biotechnology, Immunization, Breast Cancer, Cancer, 5.2 Cellular and gene therapies, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Adaptive Immunity, Breast Neoplasms, Female, Humans, Immunity, Innate, Receptor, ErbB-2, Receptors, IgG, Retrospective Studies, Survival Analysis, adaptive immunity, immunity, innate, review, breast neoplasms, Receptor, erbB-2
Abstract

Several therapeutic monoclonal antibodies (mAbs), including those targeting epidermal growth factor receptor, human epidermal growth factor receptor 2 (HER2), and CD20, mediate fragment crystallizable gamma receptor (FcγR)-dependent activities as part of their mechanism of action. These activities include induction of antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), which are innate immune mechanisms of cancer cell elimination. FcγRs are distinguished by their affinity for the Fc fragment, cell distribution, and type of immune response they induce. Activating FcγRIIIa (CD16A) on natural killer cells plays a crucial role in mediating ADCC, and activating FcγRIIa (CD32A) and FcγRIIIa on macrophages are important for mediating ADCP. Polymorphisms in FcγRIIIa and FcγRIIa generate variants that bind to the Fc portion of antibodies with different affinities. This results in differential FcγR-mediated activities associated with differential therapeutic outcomes across multiple clinical settings, from early stage to metastatic disease, in patients with HER2+ breast cancer treated with the anti-HER2 mAb trastuzumab. Trastuzumab has, nonetheless, revolutionized HER2+ breast cancer treatment, and several HER2-directed mAbs have been developed using Fc glyco-engineering or Fc protein-engineering to enhance FcγR-mediated functions. An example of an approved anti-HER2 Fc-engineered chimeric mAb is margetuximab, which targets the same epitope as trastuzumab, but features five amino acid substitutions in the IgG 1 Fc domain that were deliberately introduced to increase binding to activating FcγRIIIa and decrease binding to inhibitory FcγRIIb (CD32B). Margetuximab enhances Fc-dependent ADCC in vitro more potently than the combination of pertuzumab (another approved mAb directed against an alternate HER2 epitope) and trastuzumab. Margetuximab administration also enhances HER2-specific B cell and T cell-mediated responses ex vivo in samples from patients treated with prior lines of HER2 antibody-based therapies. Stemming from these observations, a worthwhile future goal in the treatment of HER2+ breast cancer is to promote combinatorial approaches that better eradicate HER2+ cancer cells via enhanced immunological mechanisms.

Published
2022

8. Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast CancerBiomarker Analysis of the Phase III NALA Study in HER2+ MBC

Author

Saura, Cristina, Matito, Judit, Oliveira, Mafalda, Wildiers, Hans, Brufksy, Adam M, Waters, Simon H, Hurvitz, Sara A, Moy, Beverly, Kim, Sung-Bae, Gradishar, William J, Queiroz, Geraldo Silva, Cronemberger, Eduardo, Wallweber, Gerald J, Bebchuk, Judith, Keyvanjah, Kiana, Lalani, Alshad S, Bryce, Richard, Vivancos, Ana, Eli, Lisa D, and Delaloge, Suzette

Subjects
Breast Cancer, Cancer, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Breast Neoplasms, Capecitabine, Correlation of Data, Female, Humans, Lapatinib, Neoplasm Metastasis, Quinolines, Retreatment, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeNeratinib plus capecitabine (N+C) demonstrated significant progression-free survival (PFS) benefit in NALA (NCT01808573), a randomized phase III trial comparing N+C with lapatinib + capecitabine (L+C) in 621 patients with HER2-positive (HER2+) metastatic breast cancer (MBC) who had received ≥2 prior HER2-directed regimens in the metastatic setting. We evaluated correlations between exploratory biomarkers and PFS.Patients and methodsSomatic mutations were evaluated by next-generation sequencing on primary or metastatic samples. HER2 protein expression was evaluated by central IHC, H-score, and VeraTag/HERmark. p95 expression (truncated HER2) was measured by VeraTag. HRs were estimated using unstratified Cox proportional hazards models.ResultsFour hundred and twenty samples had successful sequencing: 34.0% had PIK3CA mutations and 5.5% had HER2 (ERBB2) mutations. In the combined patient populations, PIK3CA mutations trended toward shorter PFS [wild-type vs. mutant, HR = 0.81; 95% confidence interval (CI), 0.64-1.03], whereas HER2 mutations trended toward longer PFS [HR = 1.69 (95% CI, 0.97-3.29)]. Higher HER2 protein expression was associated with longer PFS [IHC 3+ vs. 2+, HR = 0.67 (0.54-0.82); H-score ≥240 versus

Published
2021

9. A randomized phase III double-blind placebo-controlled trial of first line chemotherapy and trastuzumab with or without bevacizumab for patients with HER2/neu-positive metastatic breast cancer: a trial of the ECOG-ACRIN Cancer Research Group (E1105)

Author

Mezzanotte-Sharpe, Jessica, primary, ONeill, Anne, additional, Mayer, Ingrid A., additional, Arteaga, Carlos L., additional, Yang, Ximing J, additional, Wagner, Lynne I., additional, Cella, David, additional, Meropol, Neal J., additional, Alpaugh, R. Katherine, additional, Saphner, Thomas J., additional, Swaney, Robert E., additional, Hoelzer, Karen L, additional, Gradishar, William J., additional, Abramson, Vandana G., additional, Sundaram, P. Kothai, additional, Jilani, Shamim Z., additional, Perez, Edith A., additional, Lin, Nancy U., additional, Jahanzeb, Mohammad, additional, Wolff, Antonio C., additional, Sledge, George W., additional, and Reid, Sonya A., additional

Published
2024
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11. Pharmacological suppression of the OTUD4-CD73 proteolytic axis revives antitumor immunity against immune-suppressive breast cancers

Author

Zhu, Yueming, primary, Banerjee, Anupam, additional, Xie, Ping, additional, Ivanov, Andrey A., additional, Uddin, Amad, additional, Jiao, Qiao, additional, Chi, Junlong J., additional, Zeng, Lidan, additional, Lee, Ji Young, additional, Xue, Yifan, additional, Lu, Xinghua, additional, Cristofanilli, Massimo, additional, Gradishar, William J., additional, Henry, Curtis J., additional, Gillespie, Theresa W., additional, Bhave, Manali Ajay, additional, Kalinsky, Kevin, additional, Fu, Haian, additional, Bahar, Ivet, additional, Zhang, Bin, additional, and Wan, Yong, additional

Published
2024
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12. Coping strategies and psychosocial resources among women living with metastatic breast cancer: A qualitative study.

Author

Noriega Esquives, Blanca S., Walsh, Emily A., Penedo, Frank J., Thomas, Jessica L., Horner, Fiona S., Torzewski, Joanna B., Gradishar, William J., Victorson, David E., and Moreno, Patricia I.

Subjects
PSYCHOTHERAPY, QUALITATIVE research, FOCUS groups, STRESS management, OPTIMISM, GROUP identity, BREAST tumors, POSITIVE psychology, CANCER, MINDFULNESS, PSYCHOLOGY of women, PSYCHOLOGICAL adaptation, TREATMENT effectiveness, ATTITUDE (Psychology), MEDICAL research, RELIGION, SOCIAL support, INTERPERSONAL relations, PATIENTS' attitudes, AVOIDANCE (Psychology)
Abstract

Objective: Despite more women living with metastatic breast cancer (MBC), this population is underrepresented in cancer survivorship research. Few studies have assessed how women with MBC cope with their cancer experience. This qualitative study describes the coping strategies and psychosocial resources utilized by women living with MBC.Methods: Twenty-two women with MBC participated in four focus groups. Transcripts were analyzed using a general inductive approach. Codes derived from participants' responses were subsequently condensed into themes.Results: We identified 12 coping strategies and psychosocial resources and grouped them into five themes: Behavioral Coping Strategies (i.e. stress management, active coping and planning); Cognitive Coping Strategies and Psychological Resources (i.e. cognitive reappraisal, optimism, mindfulness, positive thinking, and religious coping); Existential Approach-Oriented Coping (i.e. acceptance, values-based living, and identity integration); Avoidance (i.e. avoidant coping); and Interpersonal Resources and Seeking Social Support (i.e. social support).Conclusions: Women living with MBC utilize several engagement and disengagement coping strategies, as well as intrapersonal and interpersonal resources. This study provides useful perspectives of women living with MBC that may inform the development of psychosocial interventions. Further research is needed to assess coping strategies and psychosocial resources across different subgroups of MBC patients and determine their impact on cancer outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Accuracy and Reproducibility of ChatGPT Responses to 362 Breast Cancer Tumor Board Cases

Author

Liao, Ning, primary, Li, Cheukfai, additional, Gradishar, William J., additional, Klimberg, V. Suzanne, additional, Roshal, Joshua A., additional, Yuan, Taize, additional, Agarwala, Sanjiv S., additional, Valero, Vicente, additional, Swain, Sandra M., additional, Margenthaler, Julie A., additional, Rubio, Isabel T., additional, Hurvitz, Sara A., additional, Geyer Jr., Charles E., additional, Lin, Nancy, additional, Rugo, Hope S., additional, Wood, William, additional, Zhang, Guochun, additional, Liu, Nanqui, additional, and Balch, Charles M., additional

Published
2024
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17. Supplementary Video S20 from Dynamic Glycoprotein Hyposialylation Promotes Chemotherapy Evasion and Metastatic Seeding of Quiescent Circulating Tumor Cell Clusters in Breast Cancer

Author

Dashzeveg, Nurmaa K., primary, Jia, Yuzhi, primary, Zhang, Youbin, primary, Gerratana, Lorenzo, primary, Patel, Priyam, primary, Shajahan, Asif, primary, Dandar, Tsogbadrakh, primary, Ramos, Erika K., primary, Almubarak, Hannah F., primary, Adorno-Cruz, Valery, primary, Taftaf, Rokana, primary, Schuster, Emma J., primary, Scholten, David, primary, Sokolowski, Michael T., primary, Reduzzi, Carolina, primary, El-Shennawy, Lamiaa, primary, Hoffmann, Andrew D., primary, Manai, Maroua, primary, Zhang, Qiang, primary, D'Amico, Paolo, primary, Azadi, Parastoo, primary, Colley, Karen J., primary, Platanias, Leonidas C., primary, Shah, Ami N., primary, Gradishar, William J., primary, Cristofanilli, Massimo, primary, Muller, William A., primary, Cobb, Brian A., primary, and Liu, Huiping, primary

Published
2023
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18. Supplementary Excel S3 from Dynamic Glycoprotein Hyposialylation Promotes Chemotherapy Evasion and Metastatic Seeding of Quiescent Circulating Tumor Cell Clusters in Breast Cancer

Author

Dashzeveg, Nurmaa K., primary, Jia, Yuzhi, primary, Zhang, Youbin, primary, Gerratana, Lorenzo, primary, Patel, Priyam, primary, Shajahan, Asif, primary, Dandar, Tsogbadrakh, primary, Ramos, Erika K., primary, Almubarak, Hannah F., primary, Adorno-Cruz, Valery, primary, Taftaf, Rokana, primary, Schuster, Emma J., primary, Scholten, David, primary, Sokolowski, Michael T., primary, Reduzzi, Carolina, primary, El-Shennawy, Lamiaa, primary, Hoffmann, Andrew D., primary, Manai, Maroua, primary, Zhang, Qiang, primary, D'Amico, Paolo, primary, Azadi, Parastoo, primary, Colley, Karen J., primary, Platanias, Leonidas C., primary, Shah, Ami N., primary, Gradishar, William J., primary, Cristofanilli, Massimo, primary, Muller, William A., primary, Cobb, Brian A., primary, and Liu, Huiping, primary

Published
2023
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19. Data from Dynamic Glycoprotein Hyposialylation Promotes Chemotherapy Evasion and Metastatic Seeding of Quiescent Circulating Tumor Cell Clusters in Breast Cancer

Author

Dashzeveg, Nurmaa K., primary, Jia, Yuzhi, primary, Zhang, Youbin, primary, Gerratana, Lorenzo, primary, Patel, Priyam, primary, Shajahan, Asif, primary, Dandar, Tsogbadrakh, primary, Ramos, Erika K., primary, Almubarak, Hannah F., primary, Adorno-Cruz, Valery, primary, Taftaf, Rokana, primary, Schuster, Emma J., primary, Scholten, David, primary, Sokolowski, Michael T., primary, Reduzzi, Carolina, primary, El-Shennawy, Lamiaa, primary, Hoffmann, Andrew D., primary, Manai, Maroua, primary, Zhang, Qiang, primary, D'Amico, Paolo, primary, Azadi, Parastoo, primary, Colley, Karen J., primary, Platanias, Leonidas C., primary, Shah, Ami N., primary, Gradishar, William J., primary, Cristofanilli, Massimo, primary, Muller, William A., primary, Cobb, Brian A., primary, and Liu, Huiping, primary

Published
2023
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20. Supplementary Tables S1-S2 from Dynamic Glycoprotein Hyposialylation Promotes Chemotherapy Evasion and Metastatic Seeding of Quiescent Circulating Tumor Cell Clusters in Breast Cancer

Author

Dashzeveg, Nurmaa K., primary, Jia, Yuzhi, primary, Zhang, Youbin, primary, Gerratana, Lorenzo, primary, Patel, Priyam, primary, Shajahan, Asif, primary, Dandar, Tsogbadrakh, primary, Ramos, Erika K., primary, Almubarak, Hannah F., primary, Adorno-Cruz, Valery, primary, Taftaf, Rokana, primary, Schuster, Emma J., primary, Scholten, David, primary, Sokolowski, Michael T., primary, Reduzzi, Carolina, primary, El-Shennawy, Lamiaa, primary, Hoffmann, Andrew D., primary, Manai, Maroua, primary, Zhang, Qiang, primary, D'Amico, Paolo, primary, Azadi, Parastoo, primary, Colley, Karen J., primary, Platanias, Leonidas C., primary, Shah, Ami N., primary, Gradishar, William J., primary, Cristofanilli, Massimo, primary, Muller, William A., primary, Cobb, Brian A., primary, and Liu, Huiping, primary

Published
2023
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21. Supplementary Figures S1-S17 from Dynamic Glycoprotein Hyposialylation Promotes Chemotherapy Evasion and Metastatic Seeding of Quiescent Circulating Tumor Cell Clusters in Breast Cancer

Author

Dashzeveg, Nurmaa K., primary, Jia, Yuzhi, primary, Zhang, Youbin, primary, Gerratana, Lorenzo, primary, Patel, Priyam, primary, Shajahan, Asif, primary, Dandar, Tsogbadrakh, primary, Ramos, Erika K., primary, Almubarak, Hannah F., primary, Adorno-Cruz, Valery, primary, Taftaf, Rokana, primary, Schuster, Emma J., primary, Scholten, David, primary, Sokolowski, Michael T., primary, Reduzzi, Carolina, primary, El-Shennawy, Lamiaa, primary, Hoffmann, Andrew D., primary, Manai, Maroua, primary, Zhang, Qiang, primary, D'Amico, Paolo, primary, Azadi, Parastoo, primary, Colley, Karen J., primary, Platanias, Leonidas C., primary, Shah, Ami N., primary, Gradishar, William J., primary, Cristofanilli, Massimo, primary, Muller, William A., primary, Cobb, Brian A., primary, and Liu, Huiping, primary

Published
2023
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22. Dynamic Glycoprotein Hyposialylation Promotes Chemotherapy Evasion and Metastatic Seeding of Quiescent Circulating Tumor Cell Clusters in Breast Cancer

Author

Dashzeveg, Nurmaa K., primary, Jia, Yuzhi, additional, Zhang, Youbin, additional, Gerratana, Lorenzo, additional, Patel, Priyam, additional, Shajahan, Asif, additional, Dandar, Tsogbadrakh, additional, Ramos, Erika K., additional, Almubarak, Hannah F., additional, Adorno-Cruz, Valery, additional, Taftaf, Rokana, additional, Schuster, Emma J., additional, Scholten, David, additional, Sokolowski, Michael T., additional, Reduzzi, Carolina, additional, El-Shennawy, Lamiaa, additional, Hoffmann, Andrew D., additional, Manai, Maroua, additional, Zhang, Qiang, additional, D'Amico, Paolo, additional, Azadi, Parastoo, additional, Colley, Karen J., additional, Platanias, Leonidas C., additional, Shah, Ami N., additional, Gradishar, William J., additional, Cristofanilli, Massimo, additional, Muller, William A., additional, Cobb, Brian A., additional, and Liu, Huiping, additional

Published
2023
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23. Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer: MAINTAIN Trial

Author

Kalinsky, Kevin, primary, Accordino, Melissa K., additional, Chiuzan, Codruta, additional, Mundi, Prabhjot S., additional, Sakach, Elizabeth, additional, Sathe, Claire, additional, Ahn, Heejoon, additional, Trivedi, Meghna S., additional, Novik, Yelena, additional, Tiersten, Amy, additional, Raptis, George, additional, Baer, Lea N., additional, Oh, Sun Y., additional, Zelnak, Amelia B., additional, Wisinski, Kari B., additional, Andreopoulou, Eleni, additional, Gradishar, William J., additional, Stringer-Reasor, Erica, additional, Reid, Sonya A., additional, O'Dea, Anne, additional, O'Regan, Ruth, additional, Crew, Katherine D., additional, and Hershman, Dawn L., additional

Published
2023
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25. Cyclin-Dependent Kinase 4/6 Inhibitors Beyond Progression in Metastatic Breast Cancer: A Retrospective Real-World Biomarker Analysis

Author

Gerratana, Lorenzo, primary, Davis, Andrew A., additional, Velimirovic, Marko, additional, Reduzzi, Carolina, additional, Clifton, Katherine, additional, Bucheit, Leslie, additional, Hensing, Whitney L., additional, Shah, Ami N., additional, Pivetta, Tania, additional, Dai, Charles S., additional, D'Amico, Paolo, additional, Wehbe, Firas, additional, Medford, Arielle, additional, Wander, Seth A., additional, Gradishar, William J., additional, Behdad, Amir, additional, Ma, Cynthia X., additional, Puglisi, Fabio, additional, Bardia, Aditya, additional, and Cristofanilli, Massimo, additional

Published
2023
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26. Computational ranking-assisted identification of Plexin-B2 in homotypic and heterotypic clustering of circulating tumor cells in breast cancer metastasis

Author

Schuster, Emma, primary, Dashzeveg, Nurmaa, additional, Jia, Yuzhi, additional, Golam, Kibria, additional, Zhang, Tong, additional, Hoffman, Andrew, additional, Zhang, Youbin, additional, Zheng, Chunlei, additional, Ramos, Erika, additional, Taftaf, Rokana, additional, Shennawy, Lamiaa El-, additional, Scholten, David, additional, Kitata, Reta B., additional, Adorno-Cruz, Valery, additional, Reduzzi, Carolina, additional, Spahija, Sabina, additional, Xu, Rong, additional, Siziopikou, Kalliopi P., additional, Platanias, Leonidas C., additional, Shah, Ami, additional, Gradishar, William J., additional, Cristofanilli, Massimo, additional, Tsai, Chia-Feng, additional, Shi, Tujin, additional, and Liu, Huiping, additional

Published
2023
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27. Supplementary Table S1 from Clinical and Translational Results of a Phase II, Randomized Trial of an Anti–IGF-1R (Cixutumumab) in Women with Breast Cancer That Progressed on Endocrine Therapy

Author

Gradishar, William J., primary, Yardley, Denise A., primary, Layman, Rachel, primary, Sparano, Joseph A., primary, Chuang, Ellen, primary, Northfelt, Donald W., primary, Schwartz, Gary N., primary, Youssoufian, Hagop, primary, Tang, Shande, primary, Novosiadly, Ruslan, primary, Forest, Amelie, primary, Nguyen, Tuan S., primary, Cosaert, Jan, primary, Grebennik, Dmitri, primary, and Haluska, Paul, primary

Published
2023
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29. Supplementary Figure Legends from Clinical and Translational Results of a Phase II, Randomized Trial of an Anti–IGF-1R (Cixutumumab) in Women with Breast Cancer That Progressed on Endocrine Therapy

Author

Gradishar, William J., primary, Yardley, Denise A., primary, Layman, Rachel, primary, Sparano, Joseph A., primary, Chuang, Ellen, primary, Northfelt, Donald W., primary, Schwartz, Gary N., primary, Youssoufian, Hagop, primary, Tang, Shande, primary, Novosiadly, Ruslan, primary, Forest, Amelie, primary, Nguyen, Tuan S., primary, Cosaert, Jan, primary, Grebennik, Dmitri, primary, and Haluska, Paul, primary

Published
2023
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31. Supplementary Table S1. from Cell-Free DNA and Circulating Tumor Cells: Comprehensive Liquid Biopsy Analysis in Advanced Breast Cancer

Author

Rossi, Giovanna, primary, Mu, Zhaomei, primary, Rademaker, Alfred W., primary, Austin, Laura K., primary, Strickland, Kimberly S., primary, Costa, Ricardo Lima Barros, primary, Nagy, Rebecca J., primary, Zagonel, Vittorina, primary, Taxter, Timothy J., primary, Behdad, Amir, primary, Wehbe, Firas H., primary, Platanias, Leonidas C., primary, Gradishar, William J., primary, and Cristofanilli, Massimo, primary

Published
2023
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32. Supplementary Data from The Use of Serial Circulating Tumor DNA to Detect Resistance Alterations in Progressive Metastatic Breast Cancer

Author

Jacob, Saya, primary, Davis, Andrew A., primary, Gerratana, Lorenzo, primary, Velimirovic, Marko, primary, Shah, Ami N., primary, Wehbe, Firas, primary, Katam, Neelima, primary, Zhang, Qiang, primary, Flaum, Lisa, primary, Siziopikou, Kalliopi P., primary, Platanias, Leonidas C., primary, Gradishar, William J., primary, Behdad, Amir, primary, Bardia, Aditya, primary, and Cristofanilli, Massimo, primary

Published
2023
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35. Supplementary Figure S2 from Clinical and Translational Results of a Phase II, Randomized Trial of an Anti–IGF-1R (Cixutumumab) in Women with Breast Cancer That Progressed on Endocrine Therapy

Author

Gradishar, William J., primary, Yardley, Denise A., primary, Layman, Rachel, primary, Sparano, Joseph A., primary, Chuang, Ellen, primary, Northfelt, Donald W., primary, Schwartz, Gary N., primary, Youssoufian, Hagop, primary, Tang, Shande, primary, Novosiadly, Ruslan, primary, Forest, Amelie, primary, Nguyen, Tuan S., primary, Cosaert, Jan, primary, Grebennik, Dmitri, primary, and Haluska, Paul, primary

Published
2023
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36. Proteolytic regulation of CD73 by TRIM21 orchestrates tumor immunogenicity

Author

Fu, Ziyi, primary, Chen, Siqi, additional, Zhu, Yueming, additional, Zhang, Donghong, additional, Xie, Ping, additional, Jiao, Qiao, additional, Chi, Junlong, additional, Xu, Shipeng, additional, Xue, Yifan, additional, Lu, Xinghua, additional, Song, Xinxin, additional, Cristofanilli, Massimo, additional, Gradishar, William J., additional, Kalinsky, Kevin, additional, Yin, Yongmei, additional, Zhang, Bin, additional, and Wan, Yong, additional

Published
2023
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37. Circulating tumour DNA characterisation of invasive lobular carcinoma in patients with metastatic breast cancer

Author

Davis, Andrew A., primary, Gerratana, Lorenzo, additional, Clifton, Katherine, additional, Medford, Arielle J., additional, Velimirovic, Marko, additional, Hensing, Whitney L., additional, Bucheit, Leslie, additional, Shah, Ami N., additional, D'Amico, Paolo, additional, Reduzzi, Carolina, additional, Zhang, Qiang, additional, Dai, Charles S., additional, Denault, Elyssa N., additional, Bagegni, Nusayba A., additional, Opyrchal, Mateusz, additional, Ademuyiwa, Foluso O., additional, Bose, Ron, additional, Gradishar, William J., additional, Behdad, Amir, additional, Ma, Cynthia X., additional, Bardia, Aditya, additional, and Cristofanilli, Massimo, additional

Published
2022
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38. A phase I/II study of intrathecal trastuzumab in human epidermal growth factor receptor 2-positive (HER2-positive) cancer with leptomeningeal metastases: Safety, efficacy, and cerebrospinal fluid pharmacokinetics

Author

Kumthekar, Priya U, primary, Avram, Michael J, additional, Lassman, Andrew B, additional, Lin, Nancy U, additional, Lee, Eudocia, additional, Grimm, Sean A, additional, Schwartz, Margaret, additional, Bell Burdett, Kirsten L, additional, Lukas, Rimas V, additional, Dixit, Karan, additional, Perron, Isabella, additional, Zhang, Hui, additional, Gradishar, William J, additional, Pentsova, Elena I, additional, Jeyapalan, Suriya, additional, Groves, Morris D, additional, Melisko, Michelle, additional, and Raizer, Jeffrey J, additional

Published
2022
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39. Breast Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology

Author

Gradishar, William J., primary, Moran, Meena S., additional, Abraham, Jame, additional, Aft, Rebecca, additional, Agnese, Doreen, additional, Allison, Kimberly H., additional, Anderson, Bethany, additional, Burstein, Harold J., additional, Chew, Helen, additional, Dang, Chau, additional, Elias, Anthony D., additional, Giordano, Sharon H., additional, Goetz, Matthew P., additional, Goldstein, Lori J., additional, Hurvitz, Sara A., additional, Isakoff, Steven J., additional, Jankowitz, Rachel C., additional, Javid, Sara H., additional, Krishnamurthy, Jairam, additional, Leitch, Marilyn, additional, Lyons, Janice, additional, Mortimer, Joanne, additional, Patel, Sameer A., additional, Pierce, Lori J., additional, Rosenberger, Laura H., additional, Rugo, Hope S., additional, Sitapati, Amy, additional, Smith, Karen Lisa, additional, Smith, Mary Lou, additional, Soliman, Hatem, additional, Stringer-Reasor, Erica M., additional, Telli, Melinda L., additional, Ward, John H., additional, Wisinski, Kari B., additional, Young, Jessica S., additional, Burns, Jennifer, additional, and Kumar, Rashmi, additional

Published
2022
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42. Abstract PD14-04: Circulating tumor DNA characterization of invasive lobular carcinoma in patients with metastatic breast cancer

Author

Davis, Andrew A, primary, Gerratana, Lorenzo, additional, Clifton, Katherine, additional, Velimirovic, Marko, additional, Hensing, Whitney L, additional, Shah, Ami N, additional, D’Amico, Paolo, additional, Reduzzi, Carolina, additional, Zhang, Qiang, additional, Dai, Charles S, additional, Denault, Elyssa N, additional, Bagegni, Nusayba A, additional, Opyrchal, Mateusz, additional, Ademuyiwa, Foluso O, additional, Bose, Ron, additional, Gradishar, William J, additional, Behdad, Amir, additional, Ma, Cynthia X, additional, Bardia, Aditya, additional, and Cristofanilli, Massimo, additional

Published
2022
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43. Abstract PD14-01: Comprehensive molecular characterization of patients with metastatic invasive lobular carcinoma (ILC): Using real-world data to describe this unique clinical entity

Author

Davis, Andrew A, primary, Behdad, Amir, additional, Layng, Kayla Viets, additional, Wehbe, Firas, additional, Gerratana, Lorenzo, additional, Mauer, Elizabeth, additional, Barrett, Alex, additional, Shah, Ami N, additional, D’Amico, Paolo, additional, Flaum, Lisa, additional, Gradishar, William J, additional, Platanias, Leonidas C, additional, and Cristofanilli, Massimo, additional

Published
2022
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44. Abstract PD8-01: Phase 3 SOPHIA study of margetuximab (M) + chemotherapy (CTX) vs trastuzumab (T) + CTX in patients (pts) with HER2+ metastatic breast cancer (MBC) after prior anti-HER2 therapies: Final overall survival (OS) analysis

Author

Rugo, Hope, primary, Im, Seock-Ah, additional, Cardoso, Fatima, additional, Cortes, Javier, additional, Curigliano, Giuseppe, additional, Musolino, Antonino, additional, Pegram, Mark D., additional, Bachelot, Thomas, additional, Wright, Gail S., additional, Saura, Cristina, additional, Escrivá-de-Romaní, Santiago, additional, De Laurentiis, Michelino, additional, Schwartz, Gary N., additional, Pluard, Timothy, additional, Ricci, Francesco, additional, Gwin, William, additional, Levy, Christelle, additional, Brown-Glaberman, Ursa, additional, Ferrero, Jean-Marc, additional, de Boer, Maaike, additional, Kim, Sung-Bae, additional, Petráková, Katarína, additional, Yardley, Denise A., additional, Freedman, Orit, additional, Jakobsen, Erik H., additional, Gal-Yam, Einav Nili, additional, Yerushalmi, Rinat, additional, Fasching, Peter A., additional, Ashley, Emily, additional, Hong, Shengyan, additional, Rosales, Minori, additional, and Gradishar, William J., additional

Published
2022
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45. Abstract PD6-08: Exploring the interplay among ESR1/PIK3CA codon variants, oncogenic pathway alterations and clinical phenotype of metastatic breast cancer (MBC) through circulating tumor DNA (ctDNA) next-generation sequencing (NGS)

Author

Gerratana, Lorenzo, primary, Davis, Andrew A, additional, Velimirovic, Marko, additional, Clifton, Katherine, additional, Hensing, Whitney L, additional, Shah, Ami N, additional, Dai, Charles S, additional, Reduzzi, Carolina, additional, D’Amico, Paolo, additional, Zhang, Qiang, additional, Wehbe, Firas, additional, Wander, Seth, additional, Gradishar, William J, additional, Behdad, Amir, additional, Puglisi, Fabio, additional, Ma, Cynthia X, additional, Bardia, Aditya, additional, and Cristofanilli, Massimo, additional

Published
2022
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46. Abstract P2-08-04: Progressive metastatic breast cancer with no detectable circulating tumor DNA: Evaluating limitations of this highly sensitive tool

Author

Shah, Ami N, primary, Gerratana, Lorenzo, additional, Chandra, Shruti, additional, Mukhija, Dhruvika, additional, Katam, Neelima, additional, Kang, Anthony K, additional, Davis, Andrew A, additional, Srivastava, Millen, additional, Jacob, Saya, additional, D'Amico, Paolo, additional, Zhang, Qiang, additional, Reduzzi, Carolina, additional, Gurley, Michael, additional, Wehbe, Firas, additional, Gradishar, William J, additional, Behdad, Amir, additional, and Cristofanilli, Massimo, additional

Published
2022
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47. Abstract GS3-10: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+BC)

Author

Coombes, Charles, primary, Howell, Sasha J, additional, Krebs, Matthew G, additional, Lord, Simon, additional, Kenny, Laura M, additional, Bahl, Ash, additional, Clack, Glen, additional, Ainscow, Edward, additional, Dickinson, Paul A, additional, Fostea, Raluca, additional, Mansi, Janine, additional, Palmieri, Carlo, additional, Bertelli, Gianflippo, additional, Jeselsohn, Rinath, additional, Mitri, Zahi, additional, Gradishar, William J, additional, Sardesai, Sagar, additional, O'Shaughnessy, Joyce, additional, Ward, Patrick, additional, Chalasani, Pavani, additional, Lehnert, Manfred, additional, Ali, Simak, additional, and McIntosh, Stuart, additional

Published
2022
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49. Positive predictive value of ERBB2 copy number gain by tissue or circulating tumor DNA next-generation sequencing across advanced cancers

Author

Shah, Ami N., primary, Sunderraj, Ashwin, additional, Finkelman, Brian, additional, See, Sharlene H., additional, Davis, Andrew A., additional, Gerratana, Lorenzo, additional, Wehbe, Firas, additional, Katam, Neelima, additional, Mahalingam, Deva, additional, Gradishar, William J., additional, Behdad, Amir, additional, Blanco, Luis, additional, and Cristofanilli, Massimo, additional

Published
2022
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50. Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast Cancer

Author

Saura, Cristina, Matito, Judit, Oliveira, Mafalda, Wildiers, Hans, Brufksy, Adam M, Waters, Simon H, Hurvitz, Sara A, Moy, Beverly, Kim, Sung-Bae, Gradishar, William J, Queiroz, Geraldo Silva, Cronemberger, Eduardo, Wallweber, Gerald J, Bebchuk, Judith, Keyvanjah, Kiana, Lalani, Alshad S, Bryce, Richard, Vivancos, Ana, Eli, Lisa D, and Delaloge, Suzette

Subjects
screening and diagnosis, Tumor, Oncology and Carcinogenesis, Breast Neoplasms, Lapatinib, Detection, Antineoplastic Combined Chemotherapy Protocols, Retreatment, Breast Cancer, Quinolines, Humans, Female, Oncology & Carcinogenesis, Neoplasm Metastasis, Correlation of Data, Biomarkers, Capecitabine, Cancer, 4.2 Evaluation of markers and technologies
Abstract

PurposeNeratinib plus capecitabine (N+C) demonstrated significant progression-free survival (PFS) benefit in NALA (NCT01808573), a randomized phase III trial comparing N+C with lapatinib + capecitabine (L+C) in 621 patients with HER2-positive (HER2+) metastatic breast cancer (MBC) who had received ≥2 prior HER2-directed regimens in the metastatic setting. We evaluated correlations between exploratory biomarkers and PFS.Patients and methodsSomatic mutations were evaluated by next-generation sequencing on primary or metastatic samples. HER2 protein expression was evaluated by central IHC, H-score, and VeraTag/HERmark. p95 expression (truncated HER2) was measured by VeraTag. HRs were estimated using unstratified Cox proportional hazards models.ResultsFour hundred and twenty samples had successful sequencing: 34.0% had PIK3CA mutations and 5.5% had HER2 (ERBB2) mutations. In the combined patient populations, PIK3CA mutations trended toward shorter PFS [wild-type vs. mutant, HR = 0.81; 95% confidence interval (CI), 0.64-1.03], whereas HER2 mutations trended toward longer PFS [HR = 1.69 (95% CI, 0.97-3.29)]. Higher HER2 protein expression was associated with longer PFS [IHC 3+ vs. 2+, HR = 0.67 (0.54-0.82); H-score ≥240 versus

Published
2021

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