Recommended Dosage and Usage of Camizestrant in Patients
The recommended dose of camizestrant for patients with estrogen receptor-positive, HER2-negative advanced breast cancer is 75 mg orally once daily, which has demonstrated significant improvement in progression-free survival compared to fulvestrant with a favorable safety profile. 1
Dosage and Administration
- Camizestrant is administered as an oral tablet at a dose of 75 mg once daily 1, 2
- The 75 mg dose is considered the optimal dose for phase III clinical development based on efficacy and safety data from phase I and II trials 2
- Pharmacokinetic studies show that camizestrant reaches maximum concentration approximately 2-4 hours post-dose with an estimated half-life of 20-23 hours, supporting once-daily dosing 2
Clinical Indications
- Camizestrant is indicated for patients with estrogen receptor-positive (ER+), HER2-negative advanced breast cancer 1
- It has shown particular efficacy in patients with:
Efficacy Data
- In the SERENA-2 trial, camizestrant 75 mg demonstrated superior progression-free survival compared to fulvestrant (7.2 months vs 3.7 months; HR 0.59; p=0.017) 1
- The SERENA-6 trial showed that switching to camizestrant 75 mg in patients who developed ESR1 mutations during first-line therapy with an aromatase inhibitor plus CDK4/6 inhibitor significantly improved progression-free survival (16.0 months vs 9.2 months; HR 0.44; p<0.0001) 3
Combination Therapy
- Camizestrant 75 mg can be safely combined with CDK4/6 inhibitors (abemaciclib, palbociclib, or ribociclib) with no clinically meaningful drug-drug interactions 4
- When used in combination with CDK4/6 inhibitors in heavily pretreated patients, the clinical benefit rate at 24 weeks was 49.5% with a median progression-free survival of 7.4 months 4
Safety Profile
- Most common treatment-related adverse events with camizestrant 75 mg include:
- The majority of adverse events (82.4%) are grade 1 or 2 2
- No grade 3 or higher treatment-related adverse events or serious adverse events were reported at doses ≤150 mg 2
- Discontinuation rate due to adverse events is low (1.3%) 3
Monitoring and Follow-up
- Regular assessment of disease response using RECIST 1.1 criteria is recommended 1
- Monitoring for common adverse events, particularly visual effects and bradycardia, is advised 2
- Quality of life assessments should be performed, as camizestrant has shown delayed time to deterioration in global health status compared to aromatase inhibitors (21.0 months vs 6.4 months) 3