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1. Developing a Web-Based Shared Decision-Making Tool for Fertility Preservation Among Reproductive-Age Women With Breast Cancer: An Action Research Approach

Author

Tseng, Ling-Ming, Lien, Pei-Ju, Huang, Chen-Yu, Tsai, Yi-Fang, Chao, Ta-Chung, and Huang, Sheng-Miauh

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Abstract

BackgroundThe pregnancy rate after cancer treatment for female survivors is lower than that of the general population. Future infertility is a significant concern for patients with breast cancer and is associated with a poor quality of life. Reproductive-age patients with breast cancer have safe options when choosing a type of fertility preservation method to be applied. Better information and support resources aimed at women to support their decision making are needed. ObjectiveThe objective of this study was to develop a web-based shared decision-making tool for helping patients with breast cancer make decisions on fertility preservation. MethodsWe used the action research cycle of observing, reflecting, planning, and acting to develop a web-based shared decision-making tool. The following four phrases were applied: (1) observe and reflect—collect and analyze the decision-making experiences of patients and health care providers; (2) reflect and plan—apply the initial results to create a paper design and modify the content; (3) plan and act—brainstorm about the web pages and modify the content; (4) act and observe—evaluate the effectiveness and refine the website’s shared decision-making tool. Interviews, group meetings, and constant dialogue were conducted between the various participants at each step. Effectiveness was evaluated using the Preparation for Decision-Making scale. ResultsFive major parts were developed with the use of the action research approach. The Introduction (part 1) describes the severity of cancer treatment and infertility. Options (part 2) provides the knowledge of fertility preservation. The shared decision-making tool was designed as a step-by-step process (part 3) that involves the comparison of options, patient values, and preferences; their knowledge regarding infertility and options; and reaching a collective decision. Resources (part 4) provides information on the hospitals that provide such services, and References (part 5) lists all the literature cited in the website. The results show the web-based shared decision-making meets both patients’ and health providers’ needs and helps reproductive-age patients with breast cancer make decisions about fertility preservation. ConclusionsWe have created the first web-based shared decision-making tool for making fertility preservation decisions in Taiwan. We believe female patients of reproductive age will find the tool useful and its use will become widespread, which should increase patient autonomy and improve communication about fertility preservation with clinicians. Trial RegistrationClinicaltrials.gov NCT04602910; https://clinicaltrials.gov/ct2/show/NCT04602910

Published
2021
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2. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer

Author

Noguchi, Emi, Yamanaka, Takashi, Mukai, Hirofumi, Yamamoto, Naohito, Chung, Chi-Feng, Lu, Yen-Shen, Chang, Dwan-Ying, Sohn, Joohyuk, Kim, Gun Min, Lee, Kyung-Hun, Lee, Soo-Chin, Iwasa, Tsutomu, Iwata, Hiroji, Watanabe, Kenichi, Jung, Kyung Hae, Tanabe, Yuko, Kang, Seok Yun, Yasojima, Hiroyuki, Aogi, Kenjiro, Tokunaga, Eriko, Sim, Sung Hoon, Yap, Yoon Sim, Matsumoto, Koji, Tseng, Ling-Ming, Umeyama, Yoshiko, Sudo, Kazuki, Kojima, Yuki, Hata, Tomomi, Kuchiba, Aya, Shibata, Taro, Nakamura, Kenichi, Fujiwara, Yasuhiro, Tamura, Kenji, and Yonemori, Kan

Published
2024
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21. Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study.

Author

Huang, Chiun-Sheng, Yu, Alice L, Tseng, Ling-Ming, Chow, Louis WC, Hou, Ming-Feng, Hurvitz, Sara A, Schwab, Richard B, L Murray, James, Chang, Hsien-Kun, Chang, Hong-Tai, Chen, Shin-Cheh, Kim, Sung-Bae, Hung, Jung-Tung, Ueng, Shir-Hwa, Lee, Su-Hua, Chen, Chwen-Cheng, and Rugo, Hope S

Subjects
Humans, Breast Neoplasms, Neoplasm Metastasis, Cancer Vaccines, Vaccines, Conjugate, Treatment Outcome, Survival Analysis, Double-Blind Method, Adult, Aged, Aged, 80 and over, Middle Aged, Female, immunology, oncology, randomized trials, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Breast Cancer, Vaccine Related, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals
Abstract

This randomized, double-blind, placebo-controlled, parallel-group, phase II trial assessed the efficacy and safety of adagloxad simolenin (OBI-822; a Globo H epitope covalently linked to keyhole limpet hemocyanin (KLH)) with adjuvant OBI-821 in metastatic breast cancer (MBC). At 40 sites in Taiwan, USA, Korea, India, and Hong Kong, patients with MBC of any molecular subtype and ≤2 prior progressive disease events with stable/responding disease after the last anticancer regimen were randomized (2:1) to adagloxad simolenin (AS/OBI-821) or placebo, subcutaneously for nine doses with low-dose cyclophosphamide. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival, correlation of clinical outcome with humoral immune response and Globo H expression, and safety. Of 349 patients randomized, 348 received study drug. Patients with the following breast cancer subtypes were included: hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (70.4%), triple negative (12.9%), and HER2+ (16.7%), similarly distributed between treatment arms. Median PFS was 7.6 months (95% CI: 6.5-10.9) with AS/OBI-821 (n=224) and 9.2 months (95% CI: 7.3-11.3) with placebo (n=124) (HR=0.96; 95% CI: 0.74-1.25; p=0.77), with no difference by breast cancer subtype. AS/OBI-821 recipients with anti-Globo H IgG titer ≥1:160 had significantly longer median PFS (11.1 months (95% CI: 9.3-17.6)) versus those with titers

Published
2020

24. Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer

Author

Nuciforo, Paolo, Townend, John, Piccart, Martine J., Fielding, Shona, Gkolfi, Panagiota, El-Abed, Sarra, de Azambuja, Evandro, Werutsky, Gustavo, Bliss, Judith, Moebus, Volker, Colleoni, Marco, Aspitia, Alvaro Moreno, Gomez, Henry, Gombos, Andrea, Coccia-Portugal, Maria A., Tseng, Ling-Ming, Kunz, Georg, Lerzo, Guillermo, Sohn, Joohyuk, Semiglazov, Vladimir, Saura, Cristina, Kroep, Judith, Ferro, Antonella, Cameron, David, Gelber, Richard, Huober, Jens, and Di Cosimo, Serena

Published
2023
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28. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Author

Sevelda, Paul, Haslbauer, Ferdinand, Penzinger, Monika, Öhler, Leopold, Tinchon, Christoph, Greil, Richard, Heibl, Sonja, Bartsch, Rupert, Wette, Viktor, Singer, Christian F., Pasterk, Claudia, Helfgott, Ruth, Pristauz-Telsnigg, Gunda, Stöger, Herbert, Weltermann, Angsar, Egle, Daniel, Thiel, Irene, Fuchs, David, Rumpold, Holger, Strasser-Weippl, Kathrin, Rautenberg, Beate, Müller, Volkmar, Schmidt, Marcus, Paepke, Stefan, Aydogdu, Mustafa, Thomssen, Christoph, Rom, Joachim, Mau, Christine, Fasching, Peter, Göhring, Uwe-Jochen, Kühn, Thorsten, Noeding, Stefanie, Kümmel, Sherko, Hackmann, John, Stickeler, Elmar, Joshi, Abhishek, Dewar, Joanna, Friedlander, Michael, Phillips, Kelly-Anne, Antill, Yoland, Woodward, Natasha, Abdi, Ehtesham, Tiley, Susan, George, Mathew, Boadle, David, Goodwin, Annabel, van der Westhuizen, Andre, Kannourakis, George, Murray, Nicholas, McCarthy, Nicole, Kroep, Judith, de Boer, Maaike, Heijns, Joan, Jager, Agnes, Erdkamp, Franciscus, Bakker, Sandra, Sonke, Gabe S., Sami, Amer, Mackey, John, Prady, Catherine, Eisen, Andrea, Desbiens, Christine, Patocskai, Erica, Ferrario, Cristiano, Gelmon, Karen, Bordeleau, Louise, Chalchal, Haji, Niraula, Saroj, ido wolf, Senkus, Elżbieta, Duhoux, François, Randal d’Hondt, Luce, Sylvie, Roodenbeke, Daphné t’Kint de, Papadimitriou, Konstantinos, Borms, Marleen, Quaghebeur, Claire, Jacot, William, Brain, Etienne, Venat-Bouvet, Laurence, Lortholary, Alain, Nowecki, Zbigniew, Cardoso, Fátima, Hayward, Richard, Bella, Santiago, Lazzaro, Mauricio Fernández, Pilnik, Norma, Fein, Luis E., Blajman, Cesar, Lerzo, Guillermo, Varela, Mirta, Zarba, Juan Jose, Kaen, Diego, Constanzo, Maria Victoria, Tio, Joke, Siggelkow, Wulf, Jackisch, Christian, Grischke, Eva Maria, Zahm, Dirk, Tato-Varela, Sara, Schmatloch, Sabine, Klare, Peter, Stefek, Andrea, Rhiem, Kerstin, Hoffmann, Oliver, Deryal, Mustafa, Gröll, Isolde, Ledwon, Peter, Uleer, Christoph, Krabisch, Petra, Potenberg, Jochem, Darsow, Maren, Park-Simon, Tjoung-Won, Höffkes, Heinz-Gert, Emde, Till-Oliver, Graffunder, Gerd, Tomé, Oliver, Forstmeyer, Dirk, Terhaag, Jürgen, Salat, Christoph, Kast, Karin, Weniger, Steffi, Schreiber, Carsten, Heinrich, Bernhard, Dieterich, Max, Wüllner, Michaela Penelope, Conejero, Raquel Andrés, García Sáenz, José Ángel, Martinez, Lourdes Calvo, Lanza, Angels Arcusa, Murillo, Serafín Morales, Carrasco, Fernando Henao, Tormo, Salvador Blanch, López, Isabel Álvarez, Delgado Mingorance, Juan Ignacio, Gomez, Elena Álvarez, Santisteban, Marta, Jurado, Josefina Cruz, Quiroga, Vanesa, Borrego, Manuel Ruiz, Martínez de Dueñas, Eduardo, Alés Martínez, Jose Enrique, De la Haba, Juan, Jañez, Noelia Martínez, Lescure, Álvaro Rodríguez, Torres, Antonio Antón, Crusades, Gema Llort, González-Santiago, Santiago, Aragones, Antonia Marquez, Ortega, Ana Laura, Molins, Agusti Barnadas, Chacón López-Muñiz, José Ignacio, Jiménez, Miguel Martín, Bertrán, Ana Santaballa, Rodríguez, César, Cortijo, Lucía González, Cretella, Elisabetta, Cortesi, Laura, Ruggeri, Enzo Maria, Verusio, Claudio, Gori, Stefania, Bonetti, Andrea, Mosconi, Anna Maria, Johannsson, Oskar, Jerusalem, Guy, Neven, Patrick, Nagy, Tünde, Pinotti, Graziella, Colleoni, Marco A., Bernardo, Antonio, Gianni, Lorenzo, Bucci, Eraldo, Biganzoli, Laura, Dedes, Konstantin, Novak, Urban, Zaman, Khalil, Braybrooke, Jeremy, Winter, Matthew, Rea, Daniel, Kelleher, Muireann, Barrett, Sophie, Chan, Stephen, Hickish, Tamas, Hurwitz, Jane, Conibear, John, Jegannathen, Apurna, Parton, Marina, Tutt, Andrew, Allerton, Rozenn, Borley, Annabel, Armstrong, Anne, Copson, Ellen, Levitt, Nicola, Abraham, Jean, Perren, Timothy, Roylance, Rebecca, Ishida, Kazushige, Toyama, Tatsuya, Masuda, Norikazu, Watanabe, Junichiro, Tokunaga, Eriko, Kinoshita, Takayuki, Rai, Yoshiaki, Takada, Masahiro, Yanagita, Yasuhiro, Nakamura, Rikiya, Nakayama, Takahiro, Naoi, Yasuto, Iwata, Hiroji, Nakamura, Seigo, Takahashi, Masato, Aogi, Kenjiro, Tsugawa, Koichiro, Mukai, Hirofumi, Takano, Toshimi, Osaki, Akihiko, Sato, Nobuaki, Yamauchi, Hideko, Tokuda, Yutaka, Ito, Mitsuya, Sugimoto, Takeki, Bahadur, Shakeela W., Ganz, Patricia A., Lu, Min J., Mita, Monica M., Waisman, James, Polikoff, Jonathan A., Telli, Melinda L., Seaward, Samantha A., Suga, J. Marie, Durna, Lara N., Carney, Jennifer Fu, Menter, Alex, Puthillath, Ajithkumar, Rohatgi, Nitin, Feusner, James H., Bobolis, Kristie A., Eisenberg, Peter D., Wong, Derrick, Borges, Virginia F., Urquhart, Alexander T., Hofstatter, Erin W., McCarron, Edward C., Isaacs, Claudine, Herbolsheimer, Pia, Varadarajan, Ramya, Raben, Adam, Deveras, Ruby Anne E., Valdes-Albini, Frances, Mahtani, Reshma L., Meisel, Jane L., Sumrall, Bradley T., Jones, Cheryl F., Ofori, Samuel N., Sumida, Kenneth N.M., Karwal, Mark, Wilbur, Deborah W., Singh, (Joe), Spector, David M., Schallenkamp, John, Merkel, Douglas E., Lo, Shelly S., Khosla, Pam G., Cristofanilli, Massimo, Flaum, Lisa, Hoskins, Kent F., Cobleigh, Melody A., Lambiase, Elyse A., Hahn, Olwen M., Oliff, Ira A., Faller, Bryan A., Wade, James L., Burhani, Nafisa D., Gil, Amaryllis, Einhorn, Harvey E., Storniolo, Anna M.V., Chang, Brian K., Kalra, Maitri, Robin, Erwin L., Ansari, Bilal, Sharma, Priyanka, Dakhil, Shaker R., Deming, Richard L., Cole, John T., Hanson, David S., Ochoa, Augusto C., Garber, Judy E., Zimbler, Harvey, Armstrong, Deborah K., Tkaczuk, Katherine H.R., Riseberg, David A., O'Connor, Brian M., Openshaw, Thomas H., Zakalik, Dana, Vakhariya, Cynthia M., Schott, Anne F., Simon, Michael S., Doyle, Thomas J., Al Baghdadi, Tareq, VanderWoude, Amy, Flynn, Patrick J., Zera, Richard T., Friday, Bret E.B., Ruddy, Kathryn J., Smith, Ron, Ademuyiwa, Olabisi, Foluso, Ellis, Robert, Carlson, Jay W., Marchello, T, Benjamin, Levine, Edward A., Marcom, Paul K., Harkness, Cameron B., Tan, Antoinette R., Charles, William J., Kuzma, Charles S., Asaad, Shonda, Radford, James E., Steen, Preston D., Unnikrishnan, Madhu, Seeger, Grant R., Leu, Kirsten M.H., Copur, Mehmet S., Hauke, Ralph J., Soori, Gamini S., Arrick, Bradley A., Reeder, Jennifer G., Toppmeyer, Deborah L., Dayao, Zoneddy R., Adams, Sylvia, Andreopoulou, Eleni, Allison, Magnuson, Anampa Mesias, Jesus D., Sharma, Ruby, Ramaswamy, Bhuvaneswari, Gerds, Aaron T., Shenk, Robert R., Gross, Howard M., Trehan, Shruti, Razaq, Wajeeha, Mansoor, Abdul H., Hilton, Christie J., Brufsky, Adam M., Huynh, Chanh, Chowdhury, Nabila, Domchek, Susan M., Sigurdson, Elin R., Cescon, Terrence P., Rovito, Marc A., DeNittis, Albert S., Vogel, Victor G., Julian, Thomas B., Boyle, L.E., Baez-Diaz, Luis, Brescia, Frank J., Doster, John E., Siegel, Robert D., Wong, Lucas, Patel, Tejal, Nangia, Julie R., Jones, Catherine A., Cannon, George M., Bear, Harry D., Vachhani, Hetal, Wilkinson, Mary, Wood, Marie E., Yan, Fengting, Sui, Xingwei, van Haelst, Carol M., Specht, Jennifer M., Zhuo, Ying, Qamar, Rubina, Ryan, Matthew L., Stockham, Abigail, Virani, Shamsuddin, Gayle, Arlene A., Jubelirer, Steven J., Kurian, Sobha, Salkeni, Mohamad A., Loman, Niklas, Linderholm, Barbro, Silander, Gustav, Hallbeck, Anna-Lotta, von Wachenfeldt Väppling, Anna, Curtit, Elsa, Cardoso, Catarina, Braga, Sofia, Abreu, Miguel, Casa-Nova, Mafalda, Nave, Mónica, Ciruelos Gil, Eva María, Gelpi, Judith Balmaña, Ortega, Adela Fernández, Padró, Josep Gumà, Bermejo de las Heras, Begoña, Cao, María González, Bañuelos, Juan Cueva, Company, Jesús Alarcon, Villaró, Gemma Viñas, Estevez, Laura García, Huober, Jens, Busch, Steffi, Fehm, Tanja, Hahn, Antje, Grafe, Andrea, Noesselt, Thomas, Dewitz, Thomas, Wagner, Harald, Bechtner, Christina, Weigel, Michael, Kolberg, Hans-Christian, Decker, Thomas, Thomalla, Jörg, Hesse, Tobias, Harbeck, Nadia, Jens-Uwe Blohmer, Jan Schröder, Wolf Sütterlin, Marc, Altena, Renske, Chiu, Chang-Fang, Chen, Shin-Cheh, Hou, Ming-Feng, Chang, Yuan-Ching, Chen, Shang-Hung, Chen, Shou-Tung, Huang, Chiun-Sheng, Yeh, Dah-Cherng, Yu, Jyh-Cherng, Tseng, Ling-Ming, Chung, Wei-Pang, Mailliez, Audrey, Petit, Thierry, Delaloge, Suzette, Lévy, Christelle, Dalivoust, Philippe, Extra, Jean-Marc, Mouret-Reynier, Marie-Ange, Hardy-Bessard, Anne-Claire, Simon, Hélène, L'Haridon, Tiffenn, Mege, Alice, Giacchetti, Sylvie, Chakiba-Brugere, Camille, Gratet, Alain, Pottier, Virginie, Ferrero, Jean-Marc, Tennevet, Isabelle, Perrin, Christophe, Canon, Jean-Luc, Joris, Sofie, Shao, Zhimin, Xu, Binghe, Jiang, ZeFei, Sun, Qiang, Shen, Kunwei, Pang, Da, Zhang, Jin, Wang, Shui, Yang, Hongjian, Liao, Ning, Zheng, Hong, Fu, Peifen, Song, Chuangui, Wang, Yongsheng, Fan, Zhimin, Geng, Cuizhi, Tredan, Olivier, Landherr, László, Kaufman, Bella, Yerushalmi, Rinat, Uziely, Beatrice, Conte, Pierfranco, Zamagni, Claudio, Bianchini, Giampaolo, De Laurentiis, Michelino, Tondini, Carlo, Gebbia, Vittorio, Ciccarese, Mariangela, Sarosiek, Tomasz, Mackiewicz, Jacek, Słowińska, Anna, Kalinka, Ewa, Huzarski, Tomasz, Im, Seock-Ah, Jung, Kyung Hae, Sohn, Joo Hyuk, Kim, Jee Hyun, Lee, Keun Seok, Park, Yeon Hee, Lee, Kyoung Eun, Chae, Yee Soo, Cho, Eun Kyung, Geyer, C.E., Jr., Garber, J.E., Gelber, R.D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A.C., Arnedos, M., Balmaña, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S.M., Eisen, A., Elsafy, F., Fein, L.E., Fielding, A., Ford, J.M., Friedman, S., Gelmon, K.A., Gianni, L., Gnant, M., Hollingsworth, S.J., Im, S.-A., Jager, A., Jóhannsson, Ó. Þ, Lakhani, S.R., Janni, W., Linderholm, B., Liu, T.-W., Loman, N., Korde, L., Loibl, S., Lucas, P.C., Marmé, F., Martinez de Dueñas, E., McConnell, R., Phillips, K.-A., Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C.F., Španić, T., Stickeler, E., Toi, M., Traina, T.A., Viale, G., Zoppoli, G., Park, Y.H., Yerushalmi, R., Yang, H., Pang, D., Jung, K.H., Mailliez, A., Fan, Z., Tennevet, I., Zhang, J., Nagy, T., Sonke, G.S., Sun, Q., Parton, M., Colleoni, M.A., Schmidt, M., Brufsky, A.M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., and Tutt, A.N.J.

Published
2022
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34. Integrating functional proteomics and next generation sequencing reveals potential therapeutic targets for Taiwanese breast cancer.

Author

Ku, Wei-Chi, Liu, Chih-Yi, Huang, Chi-Jung, Liao, Chen-Chung, Huang, Yen-Chun, Kong, Po-Hsin, Chen-Chan, Hsieh, Tseng, Ling-Ming, and Huang, Chi-Cheng

Subjects
NUCLEOTIDE sequencing, MEDICAL sciences, PROTEIN expression, BREAST cancer, CYTOLOGY
Abstract

Integrating functional proteomics and next-generation sequencing (NGS) offers a comprehensive approach to unraveling the molecular intricacies of breast cancer. This study investigates the functional interplay between genomic alterations and protein expression in Taiwanese breast cancer patients. By analyzing 61 breast cancer samples using tandem mass tag (TMT) labeling and mass spectrometry, coupled with whole-exome sequencing (WES) or targeted sequencing, we identified key genetic mutations and their impact on protein expression. Notably, pathogenic variants in BRCA1, BRCA2, PTEN, and PIK3CA were found to be clinically relevant, potentially guiding targeted therapy decisions. Additionally, we discovered trans correlations between specific gene alterations (FANCA, HRAS, PIK3CA, MAP2K1, JAK2) and the expression of 22 proteins, suggesting potential molecular mechanisms underlying breast cancer development and progression. These findings highlight the power of integrating proteomics and NGS to identify potential therapeutic targets and enhance personalized medicine strategies for Taiwanese breast cancer patients. [ABSTRACT FROM AUTHOR]

Published
2025
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36. Afatinib alone and in combination with vinorelbine or paclitaxel, in patients with HER2-positive breast cancer who failed or progressed on prior trastuzumab and/or lapatinib (LUX-Breast 2): an open-label, multicenter, phase II trial

Author

Hickish, Tamas, Mehta, Ajay, Liu, Mei-Ching, Huang, Chiun-Sheng, Arora, Rajendra Singh, Chang, Yuan-Ching, Yang, Youngsen, Vladimirov, Vladimir, Jain, Minish, Tsang, Janice, Pemberton, Karine, Sadrolhefazi, Behbood, Jin, Xidong, and Tseng, Ling-Ming

Published
2022
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37. Impact of BRCA mutation on the survival and risk of contralateral breast cancer in Asian breast cancer patients

Author

Lin, Po-Han, Chen, Shin-Cheh, Tseng, Ling-Ming, Chang, King-Jen, Huang, Ai-Chu, Cheng, Kuo-Chih, Yang, Karen, Wu, Hui-Chen, Chao, Tsu-Yi, Chang, Yuan-Ching, Lin, Peng-Chan, Kuo, Wen-Hung, Kuo, Wen-Lin, Lin, Ching-Hung, Chen, Huo-Mu, Yeh, Dah-Cherng, Liu, Liang-Chih, Liu, Chun-Yu, Wang, Ming-Yang, Lo, Chiao, Lu, Yen-Shen, and Huang, Chiun-Sheng

Published
2022
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39. Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial.

Author

Kalinsky, Kevin, primary, Bianchini, Giampaolo, additional, Hamilton, Erika P., additional, Graff, Stephanie L., additional, Park, Kyong Hwa, additional, Jeselsohn, Rinath, additional, Demirci, Umut, additional, Martin, Miguel, additional, Layman, Rachel M., additional, Hurvitz, Sara A., additional, Sammons, Sarah L, additional, Kaufman, Peter A., additional, Muñoz, Montserrat, additional, Tseng, Ling-Ming, additional, Knoderer, Holly, additional, Nguyen, Bastien, additional, Zhou, Yanhong, additional, Ravenberg, Elizabeth, additional, Litchfield, Lacey M, additional, and Wander, Seth Andrew, additional

Published
2024
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42. Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1

Author

Toi, Masakazu, Shao, Zhimin, Hurvitz, Sara, Tseng, Ling-Ming, Zhang, Qingyuan, Shen, Kunwei, Liu, Donggeng, Feng, Jifeng, Xu, Binghe, Wang, Xiaojia, Lee, Keun Seok, Ng, Ting Ying, Ridolfi, Antonia, Noel-baron, Florence, Ringeisen, Francois, and Jiang, Zefei

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Clinical Trials and Supportive Activities, Lung, Cancer, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Everolimus, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Paclitaxel, Proportional Hazards Models, Receptor, ErbB-2, Retreatment, Trastuzumab, Treatment Outcome, Young Adult, Advanced breast cancer, BOLERO-1, HER2, Metastatic breast cancer, Asian, Receptor, erbB-2, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundThe current exploratory analysis was performed to evaluate the efficacy and safety of everolimus for treatment of human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer in the Asian subset of patients in the BOLERO-1 trial.MethodsPostmenopausal women with HER2+ advanced breast cancer, who had not received systemic therapy for advanced disease, were randomized 2:1 to receive everolimus or placebo, plus trastuzumab and paclitaxel. The two primary end points were investigator-assessed progression-free survival (PFS) in the full population and in the hormone receptor-negative (HR-) subpopulation. Secondary end points included assessment of the objective response rate, the clinical benefit rate, and safety.ResultsIn the Asian subset, median PFS was similar in the everolimus (n = 198) and placebo (n = 105) arms in the full analysis set (hazard ratio = 0.82 (95% CI 0.61-1.11)). In the HR- subpopulation, everolimus prolonged median PFS by 10.97 months vs placebo (25.46 vs 14.49 months; hazard ratio = 0.48 (95% CI 0.29-0.79)). In the everolimus arm of the Asian subset, the most common adverse events of any grade were stomatitis (62.2%), diarrhea (48.0%), rash (43.4%) and neutropenia (42.3%). Neutropenia (grade 3: 27.6%; grade 4: 4.6%) and decreased neutrophil count (grade 3: 11.2%; grade 4: 3.6%) were the most frequent grade 3/4 adverse events. Serious adverse events included pneumonia (5.1%), pneumonitis (3.1%), and interstitial lung disease (3.1%). There were three deaths (1.5%) during treatment in the everolimus arm vs none in the placebo arm.ConclusionsThe efficacy and safety of everolimus plus trastuzumab and paclitaxel as first-line treatment for HER2+ advanced breast cancer in the Asian subset was consistent with that reported previously in the overall population.Trial registrationClinicalTrials.gov, NCT00876395 . Registered on 2 April 2009.

Published
2017

43. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Baselga, José, Im, Seock-Ah, Iwata, Hiroji, Cortés, Javier, De Laurentiis, Michele, Jiang, Zefei, Arteaga, Carlos L, Jonat, Walter, Clemons, Mark, Ito, Yoshinori, Awada, Ahmad, Chia, Stephen, Jagiełło-Gruszfeld, Agnieszka, Pistilli, Barbara, Tseng, Ling-Ming, Hurvitz, Sara, Masuda, Norikazu, Takahashi, Masato, Vuylsteke, Peter, Hachemi, Soulef, Dharan, Bharani, Di Tomaso, Emmanuelle, Urban, Patrick, Massacesi, Cristian, and Campone, Mario

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Estrogen, Clinical Trials and Supportive Activities, Breast Cancer, Cancer, Aging, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Alanine Transaminase, Aminopyridines, Antineoplastic Combined Chemotherapy Protocols, Aspartate Aminotransferases, Biomarkers, Tumor, Breast Neoplasms, Class I Phosphatidylinositol 3-Kinases, DNA Mutational Analysis, DNA, Neoplasm, Disease-Free Survival, Double-Blind Method, Drug Eruptions, Estradiol, Exanthema, Female, Fulvestrant, Humans, Hyperglycemia, Middle Aged, Morpholines, Neoplasm Metastasis, Phosphatidylinositol 3-Kinases, Postmenopause, Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone, Response Evaluation Criteria in Solid Tumors, Retreatment, Signal Transduction, Survival Rate, Receptor, erbB-2, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundPhosphatidylinositol 3-kinase (PI3K) pathway activation is a hallmark of endocrine therapy-resistant, hormone receptor-positive breast cancer. This phase 3 study assessed the efficacy of the pan-PI3K inhibitor buparlisib plus fulvestrant in patients with advanced breast cancer, including an evaluation of the PI3K pathway activation status as a biomarker for clinical benefit.MethodsThe BELLE-2 trial was a randomised, double-blind, placebo-controlled, multicentre study. Postmenopausal women aged 18 years or older with histologically confirmed, hormone receptor-positive and human epidermal growth factor (HER2)-negative inoperable locally advanced or metastatic breast cancer whose disease had progressed on or after aromatase inhibitor treatment and had received up to one previous line of chemotherapy for advanced disease were included. Eligible patients were randomly assigned (1:1) using interactive voice response technology (block size of 6) on day 15 of cycle 1 to receive oral buparlisib (100 mg/day) or matching placebo, starting on day 15 of cycle 1, plus intramuscular fulvestrant (500 mg) on days 1 and 15 of cycle 1, and on day 1 of subsequent 28-day cycles. Patients were assigned randomisation numbers with a validated interactive response technology; these numbers were linked to different treatment groups which in turn were linked to treatment numbers. PI3K status in tumour tissue was determined via central laboratory during a 14-day run-in phase. Randomisation was stratified by PI3K pathway activation status (activated vs non-activated vs and unknown) and visceral disease status (present vs absent). Patients, investigators, local radiologists, study team, and anyone involved in the study were masked to the identity of the treatment until unblinding. The primary endpoints were progression-free survival by local investigator assessment per Response Evaluation Criteria In Solid Tumors (version 1.1) in the total population, in patients with known (activated or non-activated) PI3K pathway status, and in PI3K pathway-activated patients. Efficacy analyses were done in the intention-to-treat population. Safety was analysed in all patients who received at least one dose of study drug and had at least one post-baseline safety assessment according to the treatment they received. This trial is registered with ClinicalTrials.gov, number NCT01610284, and is currently ongoing but not recruiting participants.FindingsBetween Sept 7, 2012, and Sept 10, 2014, 1147 patients from 267 centres in 29 countries were randomly assigned to receive buparlisib (n=576) or placebo plus fulvestrant (n=571). In the total patient population (n=1147), median progression-free survival was 6·9 months (95% CI 6·8-7·8) in the buparlisib group versus 5·0 months (4·0-5·2) in the placebo group (hazard ratio [HR] 0·78 [95% CI 0·67-0·89]; one-sided p=0·00021). In patients with known PI3K status (n=851), median progression-free survival was 6·8 months (95% CI 5·0-7·0) in the buparlisib group vs 4·5 months (3·3-5·0) in the placebo group (HR 0·80 [95% CI 0·68-0·94]; one-sided p=0·0033). In PI3K pathway-activated patients (n=372), median progression-free survival was 6·8 months (95% CI 4·9-7·1) in the buparlisib group versus 4·0 months (3·1-5·2) in the placebo group (HR 0·76 [0·60-0·97], one-sided p=0·014). The most common grade 3-4 adverse events in the buparlisib group versus the placebo group were increased alanine aminotransferase (146 [25%] of 573 patients vs six [1%] of 570), increased aspartate aminotransferase (103 [18%] vs 16 [3%]), hyperglycaemia (88 [15%] vs one [

Published
2017

44. Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens

Author

Dai, Ming Shen, Feng, Yin Hsun, Chen, Shang Wen, Masuda, Norikazu, Yau, Thomas, Chen, Shou Tung, Lu, Yen Shen, Yap, Yoon Sim, Ang, Peter C. S., Chu, Sung Chao, Kwong, Ava, Lee, Keun Seok, Ow, Samuel, Kim, Sung Bae, Lin, Johnson, Chung, Hyun Cheol, Ngan, Roger, Kok, Victor C., Rau, Kun Ming, Sangai, Takafumi, Ng, Ting Ying, Tseng, Ling Ming, Bryce, Richard, Bebchuk, Judith, Chen, Mei Chieh, and Hou, Ming Feng

Published
2021
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50. Abemaciclib combined with endocrine therapy as adjuvant treatment for hormone-receptor-positive, HER2−, high-risk early breast cancer: 5-year Chinese population analysis of the phase III randomized monarchE study.

Author

Zhang, Qingyuan, Shen, Kunwei, Song, Chuan-gui, Ouyang, Quchang, Liu, Zhenzhen, Liu, Qiang, Feng, Jifeng, Chiu, Joanne W. Y., Tang, Jinhai, Jiang, Zefei, Tseng, Ling-Ming, Wang, Xiaojia, Yang, Liu, Qian, Chenxi, and Shao, Zhimin

Abstract

Background: Abemaciclib was the first cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved globally in the adjuvant setting for high-risk hormone-receptor positive (HR+)/human epidermal growth factor 2 negative (HER2−) early breast cancer (EBC), based on the phase III monarchE trial. Objective: To report an exploratory Chinese population analysis based on the preplanned overall survival (OS) interim analysis with 5-year efficacy results of monarchE. Design and methods: Patients with HR+/HER2−, high-risk (⩾4 positive lymph nodes, or 1–3 nodes and either tumor size ⩾5 cm, histologic grade 3, or Ki-67 ⩾20%) EBC were randomized (1:1) to abemaciclib (150 mg twice daily for 2 years) plus endocrine therapy (ET), or ET alone. This analysis included Chinese patients enrolled in mainland China, Hong Kong, and Taiwan. The primary endpoint was invasive disease-free survival (IDFS); key secondary endpoints included distant relapse-free survival (DRFS), safety, and patient-reported outcomes (PROs). Results: Overall, 501 Chinese patients were included (abemaciclib + ET, n = 259; ET, n = 242). With a median follow-up of 53 months, the addition of abemaciclib to ET resulted in improvements in IDFS (estimated 5-year IDFS rate: 85.9% vs 79.1%; hazard ratio (HR), 0.65 (95% confidence interval (CI) 0.41–1.03)) and DRFS (estimated 5-year DRFS rate: 88.4% vs 82.3%; HR, 0.65 (95% CI, 0.39–1.07)). The most common grade ⩾3 treatment-emergent adverse events in the abemaciclib + ET versus ET groups were neutropenia (24.7% vs 0.8%) and leukopenia (22.4% vs 0.4%). Generally, no clinically meaningful difference in PROs (endocrine symptoms and fatigue) was observed between groups, except for diarrhea. Conclusion: At this prespecified OS interim analysis, which provides 5-year data, the addition of abemaciclib to ET in Chinese patients with high-risk HR+, HER2− EBC was associated with sustained and clinically meaningful improvements in IDFS and DRFS, with acceptable safety and tolerability profiles and minimal impact on PROs. These results represent the first full report of a CDK4/6 inhibitor in Chinese patients with EBC and support the positive benefit–risk profile of adjuvant abemaciclib + ET in Chinese patients. Trial registration: ClinicalTrials.gov identifier: NCT03155997 (first posted: May 16, 2017). [ABSTRACT FROM AUTHOR]

Published
2024
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