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PIK3CA mutante HR+/HER2- mama metastática con perfil de co-alteración (resistente a...

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IDRF-BREAST-PIK3CA-COALT-INAVOLISIB-CANDIDATE
TipoSeñal de alerta
Situaciónreviewed 2026-04-29 | pending_clinical_signoff
EnfermedadesDIS-BREAST
FuentesSRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025

Origen de la bandera roja

DefiniciónPIK3CA-mutant HR+/HER2- metastatic breast with co-alteration profile (endocrine-resistant biology — relapse on / within 12 months of adjuvant endocrine therapy OR de novo metastatic with rapid progression). INAVO120 (Jhaveri 2024) randomized first-line endocrine-resistant PIK3CA-mut HR+/HER2- MBC to inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant (mPFS 15.0 vs 7.3 mo, HR 0.43, p<0.0001). Inavolisib is a next-gen PI3Kα-selective + mutant-specific degrader with reduced hyperglycemia vs alpelisib. Candidate RF positions the 1L INAVO120 triplet specifically — distinct from RF-BREAST-PIK3CA-MUT-ACTIONABLE (broad 2L+ pathway-altered class).
Dirección clínicaintensificar
Categoríahigh-risk-biology
Algoritmo de cambiosALGO-BREAST-1L

Lógica de activación

{
  "all_of": [
    {
      "finding": "pik3ca_mutation",
      "value": true
    }
  ],
  "any_of": [
    {
      "finding": "endocrine_resistance",
      "value": "primary"
    },
    {
      "finding": "adjuvant_endocrine_relapse_within_12mo",
      "value": true
    },
    {
      "finding": "de_novo_metastatic",
      "value": true
    }
  ],
  "type": "biomarker"
}

Notas

Candidate RF — INAVO120 trial-Source not yet ingested (SRC-INAVO120-JHAVERI-2024 flag for ingestion chunk). FDA approved inavolisib + palbociclib + fulvestrant Oct 2024 for endocrine- resistant 1L HR+/HER2- PIK3CA-mut MBC. Differentiator from broader RF-BREAST-PIK3CA-MUT-ACTIONABLE (priority 65, 2L+ alpelisib / capivasertib): this RF gates 1L use specifically tied to endocrine- resistance criterion (relapse on / within 12 months adjuvant endocrine OR de novo metastatic with rapid progression). Priority 64 fires before broader PIK3CA RF (65) so 1L triplet route is preferred when criteria met. ALGO-BREAST-1L is the 1L decision-tree (vs ALGO-BREAST-HR-POS-2L for the broader RF). Inavolisib hyperglycemia rate ~6% (much lower than alpelisib ~64%); diarrhea + rash + stomatitis remain class effects. Promote to draft:false once trial-Source ingested.

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Indicación