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Dr Cristofanilli on the Next Steps With Camizestrant in HR+/HER2– Breast Cancer

Supplements and Featured Publications, Unpacking Pivotal Data Updates in Metastatic Breast Cancer Management, Volume 1, Issue 1

Massimo Cristofanilli, MD, discusses the next steps with camizestrant in ESR1-mutated HR-positive, HER2-negative advanced breast cancer.

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    “We need to be able to prevent [disease] recurrence and intervene [with treatment] even earlier before they have recurrence. When disease recurrence occurs, the treatments are primarily palliative, but they can also prolong the time to the use of infusion therapy and chemotherapy.”

    Massimo Cristofanilli, MD, an attending physician at NewYork-Presbyterian Hospital and a professor of medicine at Weill Cornell Medical College, discussed future research directions with camizestrant in patients with ESR1-mutated hormone receptor–positive, HER2-negative advanced breast cancer.

    Findings from the phase 3 SERENA-6 trial(NCT04964934) presented during the 2025 ASCO Annual Meeting demonstrated that patients who received camizestrant in combination with a CDK4/6 inhibitor (n = 157) achieved a median investigator-assessed progression-free survival (PFS) of 16.0 months (95% CI, 12.7-18.2) compared with 9.2 months (95% CI, 7.2-9.5) among patients who were treated with an aromatase inhibitor (AI) plus a CDK4/6 inhibitor (n = 158; adjusted HR, 0.44; 95% CI, 0.31-0.60; P < .00001). The 12-month PFS rates were 60.7% and 33.4%, respectively, and the 24-month rates were 29.7% and 5.4%, respectively. Notably, patients in the trial were randomly assigned to the investigational or control arm following the detection of an ESR1 mutation by circulating tumor DNA, which is often an indicator of disease progression, during initial therapy with an AI plus a CDK4/6 inhibitor.

    In the future, investigators will look to develop approaches that can be employed before disease recurrence and monitoring strategies to do so, Cristofanilli said. Cristofanilli noted that targeted therapies have shown efficacy in patients with disease that is resistant to endocrine therapy, a setting in which chemotherapy would have been used in the past. Ongoing clinical trials are examining camizestrant and other selective estrogen receptor degraders, as well as novel agents, in the adjuvant setting to delay the time to disease recurrence, he added.

    Additionally, disease monitoring techniques such as minimal residual disease (MRD) detection could be further used to intervene as soon as possible, Cristofanilli noted. The development of MRD-informed treatments will be a field of active study in the future, he concluded.


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