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Breast cancer (invasive) · line 2 · Alpelisib + fulvestrant (HR+/HER2- PIK3CA-mutant metastatic post-AI/CDK4/6i)

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Source YAML: complete record

Line of therapy2
Trackstandard
Linked regimenREG-ALPELISIB-FULVESTRANT-BREAST
IDIND-BREAST-HR-POS-2L-PIK3CA-ALPELISIB
TypeIndication
Statusreviewed 2026-04-27 | pending_clinical_signoff
DiseasesDIS-BREAST
SourcesSRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025 SRC-SOLAR1-ANDRE-2019

Notes

ESCAT IA. SOLAR-1 established alpelisib + fulvestrant for PIK3CA-mutant HR+/HER2- after AI ± CDK4/6i progression. Hotspots in exons 9 (E542K, E545K, helical) and 20 (H1047R, H1047L, kinase) detected by tissue NGS or ctDNA. Hyperglycemia management dominant workflow burden — pre-treatment HbA1c + fasting glucose; metformin first-line if hyperglycemic. UA access barrier: alpelisib registered but NSZU does not cover; out-of-pocket. CAPItello-291 (capivasertib) is overlapping option for this group plus AKT1/PTEN — see ALGO-BREAST-HR-POS-2L for selection rationale.

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