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Câncer de mama HER2-ultralow (IHC > 0 < 1+; manchação de membrana fraca/incompleta ≤10% do tum...

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IDRF-BREAST-HER2-ULTRALOW-CANDIDATE
TipoSinal de alerta
Estadoreviewed 2026-04-29 | pending_clinical_signoff
DoençasDIS-BREAST
FontesSRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025

Origem da bandeira vermelha

DefiniçãoHER2-ultralow breast cancer (IHC > 0 < 1+; faint/incomplete membrane staining ≤10% of tumor cells) — a sub-tier between IHC 0 and IHC 1+ not part of standard ASCO/CAP scoring. DESTINY-Breast06 (Bardia 2024 ASCO plenary) extended T-DXd benefit beyond HER2-low to HER2-ultralow HR+ metastatic breast post-endocrine + CDK4/6i, chemo-naive in the metastatic setting (HER2-low cohort mPFS 13.2 vs 8.1 mo, HR 0.62; HER2-ultralow exploratory n=153 mPFS 13.2 vs 8.3 mo, HR 0.78). FDA label expansion anticipated 2026 — candidate RF until pivotal-trial Source SRC-DESTINY-BREAST06-BARDIA-2024 ingested.
Direcção clínicaintensificar
Categoriahigh-risk-biology
Algoritmo de deslocamentosALGO-BREAST-HR-POS-2L

Lógica de Desencadeamento

{
  "any_of": [
    {
      "finding": "her2_status",
      "value": "ultralow"
    },
    {
      "finding": "her2_ihc",
      "value": "ultralow"
    },
    {
      "finding": "her2_ihc_ultralow",
      "value": true
    }
  ],
  "type": "biomarker"
}

Notas

Candidate RF — DESTINY-Breast06 trial-Source not yet ingested (SRC-DESTINY-BREAST06-BARDIA-2024 flagged in BIO-HER2-ULTRALOW notes). Pathology re-scoring required: ASCO/CAP 2018 / 2023 guideline does not formally distinguish ultralow from IHC 0; central pathology in DESTINY-Breast06 reported lower inter-observer kappa for ultralow than HER2-low. Practical consequence: rescore archival biopsy with ultralow criteria before T-DXd consideration. ILD class warning unchanged from HER2-low / HER2-positive T-DXd indications. Distinct from RF-BREAST-HER2-LOW-ACTIONABLE (which gates IHC 1+ or 2+/ISH-); this RF gates the new ultralow stratum exclusively. Priority 72 places it just below HER2-low (priority 70) so when both could theoretically fire, HER2-low wins. Promote to draft:false once trial-Source ingested and FDA approval confirmed (anticipated 2026).

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