Phase II Trial Opens: AI-Guided CDK4/6 Inhibitor Rechallenge vs Physician's Choice in HR+ HER2- Advanced Breast Cancer
247 Health News Editorial
·11 Apr 2026
·3 min read
·clinical-trialsNew phase II trial uses AI-guided biomarker analysis to identify HR+/HER2- advanced breast cancer patients who may benefit from rechallenge with different CDK4/6 inhibitors after progression. Study compares AI-selected CDK4/6 inhibitor plus fulvestrant versus physician's choice treatment.
Originally reported by ClinicalTrials.gov
References
- 1.University of California, San Diego. (2024). Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast Tumors. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT07227233
- 2.Finn, R. S., Martin, M., Rugo, H. S., Jones, S., Im, S. A., Gelmon, K., Harbeck, N., Lipatov, O. N., Walshe, J. M., Moulder, S., Gauthier, E., Lu, D. R., Randolph, S., Diéras, V., & Slamon, D. J. (2016). Palbociclib and letrozole in advanced breast cancer. New England Journal of Medicine, 375(20), 1925-1936. https://doi.org/10.1056/NEJMoa1607303
- 3.Hortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y. S., Sonke, G. S., Paluch-Shimon, S., Campone, M., Blackwell, K. L., André, F., Winer, E. P., Janni, W., Verma, S., Conte, P., Arteaga, C. L., Cameron, D. A., Petrakova, K., Hart, L. L., Villanueva, C., Chan, A., ... O'Shaughnessy, J. (2016). Ribociclib as first-line therapy for HR-positive, advanced breast cancer. New England Journal of Medicine, 375(18), 1738-1748. https://doi.org/10.1056/NEJMoa1609709
- 4.Cardoso, F., Paluch-Shimon, S., Senkus, E., Curigliano, G., Aapro, M. S., André, F., Barrios, C. H., Bergh, J., Bhattacharyya, G. S., Biganzoli, L., Boyle, F., Cardoso, M. J., Carey, L. A., Cortés, J., El Saghir, N. S., Elzayat, M., Eniu, A., Fallowfield, L., Francis, P. A., ... Winer, E. P. (2020). 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Annals of Oncology, 31(12), 1623-1649. https://doi.org/10.1016/j.annonc.2020.09.010
- 5.Wander, S. A., Cohen, O., Gong, X., Johnson, G. N., Buendia-Buendia, J. E., Lloyd, M. R., Kim, D., Luo, F., Mao, P., Helvie, K., Kowalski, K. J., Nayar, U., Buchanan, S., Langenbucher, A., Yennawar, S., Cai, S., Patel, T., Anders, L., Waks, A. G., ... Wagle, N. (2020). The genomic landscape of intrinsic and acquired resistance to cyclin-dependent kinase 4/6 inhibitors in patients with hormone receptor–positive metastatic breast cancer. Cancer Discovery, 10(8), 1174-1193. https://doi.org/10.1158/2159-8290.CD-19-1390
- 6.Li, Z., Razavi, P., Li, Q., Toy, W., Liu, B., Ping, C., Hsieh, W., Sanchez-Vega, F., Brown, D. N., Da Cruz Paula, A. F., Morris, L., Selenica, P., Eichenberger, E., Shen, R., Schultz, N., Rosen, N., Scaltriti, M., Brogi, E., Baselga, J., ... Chandarlapaty, S. (2018). Loss of the FAT1 tumor suppressor promotes resistance to CDK4/6 inhibitors via the Hippo pathway. Cancer Cell, 34(6), 893-905. https://doi.org/10.1016/j.ccell.2018.09.006
- 7.Therapeutic Goods Administration. (2024). Australian Register of Therapeutic Goods. Australian Government Department of Health. https://www.tga.gov.au/products/medicines/artg
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247 Health News Editorial
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