HER2-baja (pecho IHC 1+ O IHC 2+ ISH-negativo)
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
| ID | BIO-HER2-LOW |
|---|---|
| Tipo | Biomarcador |
| Aliaces | ERBB2 bajoHER2 IHC 1+HER2 IHC 2+/ISH-HER2-low (РМЗ — ІГХ 1+ АБО ІГХ 2+ ISH-)HER2-pecho bajo |
| Situación | reviewed 2026-04-29 | pending_clinical_signoff |
| Enfermedades | DIS-BREAST |
| Fuentes | SRC-DESTINY-BREAST04-MODI-2022 SRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025 |
Datos sobre biomarcadores
| Tipo de biomarcador | protein_expression_ihc |
|---|---|
| Medición | MétodoIHC (4B5 / HercepTest); reflejo ISH (FISH/CISH/SISH) para IHC 2+. La puntuación de mamas utiliza los criterios ASCO/CAP 2018 — tinción membranosa circunferencial ≥10%. UnidadesIHC 0 | 1+ | 2+ (ISH-non-amplified) — HER2-low = IHC 1+ OR (IHC 2+ AND ISH HER2/CEP17 ratio <2.0 AND HER2 signals/cell <4.0) |
| Productos químicos y químicos | BIO-HER2-SOLID BIO-ESTROGEN-RECEPTOR |
Notas
HER2-low (IHC 1+ OR IHC 2+/ISH-) covers ~50-55% of HER2-non-positive breast cancers. DESTINY-Breast04 (Modi 2022) established T-DXd efficacy 2L+ in HER2-low metastatic breast (HR+ post-endocrine + ≥1 prior chemo, OR TNBC post-≥1 prior chemo): mPFS 9.9 vs 5.1 mo, OS 23.4 vs 16.8 mo. DESTINY-Breast06 extended signal to HER2-ultralow (IHC ≥0 with membrane staining) post-endocrine in HR+. Pathology challenge: IHC 1+ vs 0 has poor inter-observer reproducibility — ASCO/CAP 2023 update ongoing. ILD class warning (~12% any-grade, 1-2% G≥3) is dominant safety concern. Distinct from BIO-HER2-SOLID (which is named/scoped for gastric/GEJ/CRC scoring conventions).
Utilizado por
Relevancia terapéutica
BMA-HER2-LOW-BREAST- Trastuzumab deruxtecan (T-DXd, DS-8201) is FDA-approved (Aug 2022) for unresectable or me...
Biomarcador
BIO-HER2-ULTRALOW- HER2-ultralow (pecho — IHC > 0 < 1+; mancha de membrana débil/incompleta ≤10%)
Capítulos del Manual
HB-BREAST-HR-POS-HER2-NEG-1L- HR+/HER2- metastatic breast cancer: first-line reasoning
Preguntas del manual
HQ-BREAST-HR-POS-1L-003- HQ-BREAST-HR-POS-1L-003
Indicación
IND-BREAST-HER2-LOW-2L-DATO-DXD- IND-BREAST-HER2-LOW-2L-DATO-DXD