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ASCO 2026 | PALMARES-2: ET and CDK4/6i beyond progression in HR+/HER2- breast cancer

Claudio Vernieri, MD, PhD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, presents real-world effectiveness data from the PALMARES-2 study (NCT06805812), evaluating first-line endocrine therapy (ET) plus CDK4/6 inhibitor (CDK4/6i) continuation beyond disease progression in patients with HR-positive, HER2-negative advanced breast cancer. Results demonstrated meaningful real-world progression-free survival beyond progression in patients who continued treatment, particularly those with less biologically aggressive tumors or disease amenable to locoregional therapies, supporting this approach in selected patients. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

During the Metastatic Breast Cancer session, it was my pleasure to present the effectiveness data of first-line endocrine therapy plus CDK4/6 inhibitor continuation beyond the first progressive disease event in a large cohort of 4,336 patients enrolled at the second cohort of the Palbociclib study, which is the largest real-world study that is continuously enrolling patients who start a first-line treatment with endocrine therapy plus CDK4-6 inhibitor for hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer...

During the Metastatic Breast Cancer session, it was my pleasure to present the effectiveness data of first-line endocrine therapy plus CDK4/6 inhibitor continuation beyond the first progressive disease event in a large cohort of 4,336 patients enrolled at the second cohort of the Palbociclib study, which is the largest real-world study that is continuously enrolling patients who start a first-line treatment with endocrine therapy plus CDK4-6 inhibitor for hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer. And what we found was that in clinical practice, around 20% of patients who undergo progressive disease during first-line therapy actually continue the same first-line treatment beyond PD. And the vast majority of these patients receive concomitant local regional therapies, mostly radiotherapy, to treat progressing disease. And in this subset of patients, what we found was that median real-world progression-free survival after the first PD event is 10.5 months. So these patients achieve almost one year of additional benefit from continuing the same first-line therapy and just adding local regional therapies. And this is a very important result, which was also associated with excellent overall survival with a median of 71 months. So this means that continuing first-line therapy does not affect the possibility for these patients to receive subsequent lines of therapy and to achieve long-term overall survival. Of course, these patients were very well selected based on clinical and biological features. These patients were younger, more likely to be premenopausal, to have non-special type tumors, to have higher ER and PR expression in the tumor, more likely to have bone metastases and less likely to have liver metastases when compared to the other patients. So a very well selected population of patients but clinically relevant. One out of five patients in the whole study cohort.

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