No increased risk of clinically meaningful changes in visual acuity1,2,5
- No or negligible impact on ability to drive or use machines
In SERENA-6,
Adverse reactions were mostly grade 1 or 21
1.3%
discontinued due to ARs
with ETCAMAH + CDK4/6i1,*
~90%
of patients did not
report diarrhea
9% had grade 1 or 2 diarrhea
with
ETCAMAH + CDK4/6i1
- Dose interruption of ETCAMAH due to adverse reactions occurred in 22% of patients1,†
| Adverse Reactions in ≥10% of patients1,‡ | ETCAMAH with a |
| Aromatase Inhibitor with a CDK4/6 Inhibitor (n=155) | ||
| All grades, % | Grade 3 or 4, % |
| All grades, % | Grade 3 or 4, % | |
| Eye disorders |
|
|
|
|
|
| Eye disorders |
|
|
|
|
|
| Visual disturbances§ | 34 | 0.6 |
| 16 | 0 |
| Dry eye | 12 | 0 |
| 7 | 0 |
| General disorders and administration site conditions |
|
|
|
|
|
| General disorders and administration site conditions |
|
|
|
|
|
| FatigueII | 23 | 0 |
| 19 | 0.6 |
| Musculoskeletal and connective tissue disorders |
|
|
|
|
|
| Musculoskeletal and connective tissue disorders |
|
|
|
|
|
| Arthralgia | 16 | 0 |
| 17 | 0.6 |
| Back pain | 10 | 0.6 |
| 10 | 0 |
| Gastrointestinal disorders |
|
|
|
|
|
| Gastrointestinal disorders |
|
|
|
|
|
| Nausea | 10 | 0 |
| 14 | 0.6 |
*Adverse reactions that resulted in permanent discontinuation of ETCAMAH included gastroesophageal reflux disease, cholestasis, and hepatic cytolysis (0.6% each).1
†The adverse reactions (≥2%) leading to dose interruptions were bradycardia (3.9%) and visual disturbances (2.6%).1
‡Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
§Visual disturbances include: photopsia, blurred vision, visual field defect, decreased visual acuity, visual impairment, diplopia, photophobia, and visual perseveration.1
IIFatigue includes: fatigue and asthenia.
In SERENA-6,
Cardiac events associated
with ETCAMAH were
generally low grade and reversible1
Low incidence - 8%1
No grade 3 or above
events reported2
(Grade 1–5.2%; Grade 2–2.6%)
No medical
interventions
were
required beyond
dose interruption1
Median time to onset was
17
days (range: 13-283)
Maximum decrease
in heart rate observed
on day 151
Patients with bpm <55 were excluded in SERENA-6.
Low incidence - 2.6%1
Generally low grade3,4
(Grade 1–1.3%; Grade 2–0.6%; Grade 3–0.6%)
In a dose-finding trial, a Grade 4
Torsades de Pointes was observed in one
patient with confounding factors receiving ETCAMAH + ribociclib
No clinically meaningful arrhythmia reported7
Reversible with
dose interruption3
Please see full Prescribing Information for additional information on cardiac monitoring, dose modifications, and drug interactions.
No patients discontinued
ETCAMAH due to cardiac event
3.9% of patients had a dose
interruption due to bradycardia
and 0.6% due to QTc prolongation
In SERENA-6,
Visual disturbances were reported to have no or generally minimal effect on patients' daily activities1,2
In patients who reported visual disturbances1,2,5,*:
The vast majority were grade 1
and not impacting activities of daily living
- Rates: ~90% grade 1, ~8% grade 2 and ~2% grade 3†
- Median time to onset: 8 days
- Duration: <1 minute/episode
- Frequency: ≤3 days a week
*34% of patients in the ETCAMAH + CDK4/6i arm (n=155) and 16% of patients in the AI + CDK4/6i arm (n=155).5
No baseline eye exam required1
- Nonstructural and reversible effect on the eye5,‡
- No increased severity over time5,6,§
No patients discontinued ETCAMAH due to visual disturbances1
2.6% of patients had a dose interruption due to visual disturbances1
†Grade 2: Limiting instrumental ADL (activities of daily living); Grade 3: Limiting self-care ADL.1
‡The NEI-VFQ-25 assesses how visual function affects daily activities and overall vision-related QoL (quality of life). This questionnaire comprises 11 subscales. Adherence was calculated for each timepoint and was defined as the number of patients with an evaluable questionnaire
(≥1 subscale completed) divided by the total number of patients expected to complete the questionnaire at that timepoint. At baseline, 69% of patients in the ETCAMAH + CDK4/6i arm and 59% of patients in the AI + CDK4/6i arm completed ≥1 subscale of the NEI-VFQ-25.
§Based on ophthalmological review of patients reporting visual disturbances.2
Findings from the VSAQ and NEI-VFQ-25 are exploratory and descriptive, intended to characterize patient-reported visual symptoms and function and may be subject to inherent limitations of PRO measures. Clinicians should apply their own judgment. These questionnaires were not designed to evaluate early visual disability; results may underrepresent such impairments.
In SERENA-6,
Additional safety and tolerability data1
- The median duration of exposure was 10.1 months in the ETCAMAH + CDK4/6i arm1
- Serious adverse reactions occurred in 10% of patients in the ETCAMAH + CDK4/6i arm. Serious adverse reactions in >1% of patients included urinary tract infection, pneumonia, and osteonecrosis of jaw (1.3% each). Fatal adverse reactions occurred in 1.3% of patients who received ETCAMAH + CDK4/6i including acute respiratory distress syndrome and sudden death (0.6% each)1
Laboratory abnormalities (≥10% of patients)1,*,†
Laboratory abnormalities (≥10% of patients)1,*,† | ETCAMAH + CDK4/6i (n=155) |
| AI + CDK4/6i (n=155) | ||
All grades, % | Grade ≥3, % |
| All grades, % | Grade ≥3, % | |
| Hematology |
|
|
|
|
|
| Neutrophils decreased | 68 | 42 |
| 66 | 39 |
| Leukocytes decreased | 66 | 23 |
| 58 | 17 |
| Hemoglobin decreased | 47 | 3.9 |
| 38 | 5 |
| Lymphocytes decreased | 39 | 9 |
| 37 | 8 |
| Platelets decreased | 36 | 2.6 |
| 30 | 1.3 |
| Chemistry |
|
|
|
|
|
| Aspartate aminotransferase increased | 17 | 2.6 |
| 29 | 1.3 |
| Corrected calcium decreased | 17 | 0 |
| 12 | 0.7 |
| Creatinine increased | 16 | 0.6 |
| 20 | 1.3 |
| Gamma glutamyl transferase increased | 12 | 2.7 |
| 23 | 8 |
| Alanine aminotransferase increased | 12 | 1.3 |
| 20 | 0 |
| Creatine kinase increased | 12 | 0 |
| 6 | 0 |
| Alkaline phosphatase increased | 10 | 0.7 |
| 22 | 0.7 |
*Graded according to NCI CTCAE version 5.0.1
†Includes patients with at least one baseline and one post-baseline result.1
<1% of patients had a dose modification due to liver toxicity1,‡
‡0.6% permanently discontinued due to hepatic cytolysis.1
ADL=activities of daily living; AI=aromatase inhibitor; AR=adverse reaction; CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute; NEI-VFQ-25=National Eye Institute Visual Function Questionnaire-25; QoL=quality of life; VSAQ=Visual Symptom Assessment Questionnaire.
References:
- ETCAMAH® (camizestrant) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026.
- Bidard FC, Mayer EL, Park YH, et al. SERENA-6 Study Group. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med. 2025;393(6):569-580. doi:10.1056/NEJMoa2502929
- Data on File. REF-343615. AstraZeneca Pharmaceuticals LP, 2026.
- Hamilton E, Oliveira M, Turner N, et al. A phase I dose escalation and expansion trial of the next-generation oral SERD camizestrant in women with ER-positive, HER2-negative advanced breast cancer: SERENA-1 monotherapy results. Ann Oncol. 2024;35(8):707-717. doi:10.1016/j.annonc.2024.04.012
- Brufsky A, Park YH, Bidard FC, et al. SERENA-6 visual patient-reported outcomes & safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy. Oncologist. 2026;oyag278. doi:10.1093/oncolo/oyag278
- Hamm G, Maglennon G, Purbrick S, et al. Camizestrant causes reversible pharmacological effects on retinal responses in rats. Transl Oncol. 2025;62:102539. doi:10.1016/j.tranon.2025.102539
- Data on File. REF-347237. AstraZeneca Pharmaceuticals LP, 2026.
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