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Breast cancer (invasive) · line 2 · Capivasertib + fulvestrant (HR+/HER2- PIK3CA/AKT1/PTEN-altered metastatic post-AI/CDK4/6i)

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Source YAML: complete record

Line of therapy2
Trackstandard
Linked regimenREG-CAPIVASERTIB-FULVESTRANT-BREAST
IDIND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB
TypeIndication
Statusreviewed 2026-04-27 | pending_clinical_signoff
DiseasesDIS-BREAST
SourcesSRC-CAPITELLO291-TURNER-2023 SRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025

Notes

ESCAT IA. CAPItello-291 established capivasertib + fulvestrant for HR+/HER2- with PIK3CA / AKT1 / PTEN alteration after AI ± CDK4/6i progression. Broader biomarker coverage than alpelisib (which gates only on PIK3CA): pathway-altered cohort enriched ~41% of ITT. Diarrhea (72%) management dominant workflow burden — loperamide on hand from day 1, intermittent 4-on/3-off dosing intentionally improves tolerability. UA access barrier: capivasertib not yet registered; named-patient import / EAP only. PTEN-loss definition operationally requires combined IHC + NGS (per CAPItello enrolment criteria). When both PIK3CA-mut and AKT1/PTEN coexist, capivasertib is preferred over alpelisib for pathway-spectrum coverage and intermittent-dosing tolerability.

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