Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 160 mg, 200 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- In the endocrine-sensitive setting, the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors combined with fulvestrant 500 mg (CDK4/6i+F500) had a surface under the cumulative ranking (SUCRA) of 97.3% for both progression-free survival (PFS) and overall survival (OS). The hazard ratio (HR) for OS between CDK4/6i+F500 versus fulvestrant 500 mg alone was 0.77 (95% credible interval (CrI) 0.63-0.95).
- In the endocrine-resistant setting, CDK4/6i+F500 showed a SUCRA of 95.7% for PFS, and capivasertib combined with fulvestrant 500 mg (capivasertib+F500) had a SUCRA of 84.7% for OS. The HR for OS between CDK4/6i+F500 and fulvestrant 500 mg alone was 0.77 (95% CrI 0.67-0.89).
- There is no safety information available in the reviewed documents.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| TruQap (capivasertib) Prescribing Information. | 2023 | AstraZeneca Pharmaceuticals LP., Wilmington, DE |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Endocrine therapy-based treatments in hormone receptor-positive/HER2-negative advanced breast cancer: systematic review and network meta-analysis | 2020 | ESMO Open |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Endocrine and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer-Capivasertib-Fulvestrant: ASCO Rapid Recommendation Update. | 2024 | Journal of Clinical Oncology |