SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy

Brufsky A, Park YH, Bidard FC, Mayer EL, Janni W, Ma C, Cristofanilli M, Bianchini G, Iwata H, Fasching PA, Nowecki Z, Pascual J, Chen SC, Moreau L, Ruiz-Borrego M, Shai A, Karadurmus N, Jung KH, Kikawa Y, Baird RD, Habash R, Sugarman R, Fox S, Selvi Miralles M, Huang Bartlett C, Turner N (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Book Volume: 31

Article Number: oyag278

Journal Issue: 9

DOI: 10.1093/oncolo/oyag278

Abstract

Background: We report ophthalmological assessments, patient-reported visual symptoms/functioning, and characterization of visual effect AEs from the SERENA-6 study. Materials and methods: This double-blind, placebo-controlled phase III study included 315 patients with ER-positive advanced breast cancer receiving first-line aromatase inhibitor (AI)+CDK4/6 inhibitor (CDK4/6i). Patients with emerging ESR1 mutations in ctDNA and no radiological progression were randomized 1:1 to switch to camizestrant+CDK4/6i or continue AI+CDK4/6i. Predefined group term visual effect AEs were graded (NCI-CTCAE v5.0). Ophthalmological assessments were conducted at baseline, as indicated, and at the end of treatment. Analyses of patient-reported visual effects/functioning were exploratory. Results: Visual effect AEs were reported in 49 (31.6%) patients receiving camizestrant+CDK4/6i and 25 (16.1%) patients receiving AI+CDK4/6i; 90% were grade 1; none led to discontinuation. No changes in visual acuity or ocular structure were observed. Patient-reported visual effects occurred early (by week 2) and were reversible post-treatment. The proportion of patients in the camizestrant+CDK4/6i and AI+CDK4/6i arm reporting short-lived visual effects (<1 minute) ranged from 60% to 67% vs 50% to 69%, respectively; visual effects causing no/a low degree of bother: 78%-88% vs 50%-75%, respectively. During treatment, visual functioning was comparable to baseline and between arms. Conclusion: If experienced, patient-reported visual effects (including photopsia) with camizestrant+CDK4/6i were short-lived and reversible post-treatment. Visual effect AEs with camizestrant+CDK4/6i were mostly mild and did not require treatment discontinuation or ophthalmological management. There was no impact on ocular structure, function, or visual acuity; visual effects had little/no impact on daily functioning. These findings support clinical decision-making by further characterizing the visual safety profile of camizestrant in this setting. Clinical trial registration: ClinicalTrials.gov, NCT04964934.

Involved external institutions

New York Presbyterian Hospital United States (USA) (US) Ospedale San Raffaele (früher: Centro San Raffaele del Monte Tabor Foundation) Italy (IT) Nagoya City University / 名古屋市立大学 Japan (JP) University of Pittsburgh Medical Center (UPMC) United States (USA) (US) Sungkyunkwan University (SKKU) Korea, Republic of (KR) Institut Curie France (FR) Dana-Farber Cancer Institute United States (USA) (US) Washington University in St. Louis United States (USA) (US) Maria Skłodowska-Curie Institute of Oncology / Centrum Onkologii–Instytut im. Marii Skłodowskiej-Curie w Warszawie Poland (PL) Hospital Universitario Virgen de la Victoria Spain (ES) Chang Gung Medical Foundation / 長庚醫療財團法人 / Chang Gung Memorial Hospital (CGMH) Taiwan (TW) Hospitales Universitarios Virgen Macarena y Virgen del Rocío Spain (ES) Rambam Health Care Campus Israel (IL) Asan Medical Center / 서울아산병원 Korea, Republic of (KR) Kansai Medical University Hospital Japan (JP) Cancer Research UK United Kingdom (GB) University of Miami United States (USA) (US) AstraZeneca UK Limited United Kingdom (GB) AstraZeneca (United States) United States (USA) (US) Royal Marsden Hospital / The Royal Marsden NHS Foundation Trust United Kingdom (GB) Universitätsklinikum Ulm Germany (DE)

How to cite

APA:

Brufsky, A., Park, Y.H., Bidard, F.C., Mayer, E.L., Janni, W., Ma, C.,... Turner, N. (2026). SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy. Oncologist, 31(9). https://doi.org/10.1093/oncolo/oyag278

MLA:

Brufsky, Adam, et al. "SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy." Oncologist 31.9 (2026).

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