Related Experiment Video
Updated: Aug 14, 2026
Cerenkov Luminescence Imaging (CLI) for Cancer Therapy Monitoring
Published on: November 13, 2012
SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during
Adam Brufsky1, Yeon Hee Park2, François-Clément Bidard3
1Department of Medicine, UPMC Magee-Womens Hospital, Pittsburgh, PA 15213, United States.
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.
Insights
Camizestrant plus CDK4/6 inhibitor showed mild, reversible visual side effects in advanced breast cancer patients. These effects did not impact vision or require treatment discontinuation, supporting camizestrant
Area of Science:
- Oncology
- Pharmacology
- Ophthalmology
Background:
- The SERENA-6 phase III trial evaluated camizestrant plus a CDK4/6 inhibitor in ER-positive advanced breast cancer.
- This study focused on ophthalmological assessments and visual side effects in patients with emerging ESR1 mutations.
Purpose of the Study:
- To assess ophthalmological outcomes and characterize visual adverse events (AEs) associated with camizestrant plus CDK4/6 inhibitor therapy.
- To evaluate patient-reported visual symptoms and functioning during treatment.
Main Methods:
- Double-blind, placebo-controlled trial with 315 patients receiving first-line AI+CDK4/6i.
- Randomization to camizestrant+CDK4/6i or AI+CDK4/6i for patients with emerging ESR1 mutations.
- Ophthalmologic assessments and grading of visual AEs using NCI-CTCAE v5.0.
Main Results:
- Visual effect AEs occurred in 31.6% with camizestrant vs 16.1% with placebo; most were mild (grade 1) and reversible.
- No changes in visual acuity or ocular structure were observed.
- Patient-reported visual effects were short-lived, reversible, and had minimal impact on daily functioning.
Conclusions:
- Patient-reported visual effects with camizestrant are generally mild, short-lived, and reversible.
- Camizestrant treatment did not lead to significant visual AEs requiring discontinuation or ophthalmologic intervention.
- The visual safety profile of camizestrant is favorable, supporting its clinical use in advanced breast cancer.
