# CRF — Predictor ypN0 (Nivel 3) — Hoja de abstracción
## Case Report Form — bilingual (ES/EN) — print as A4 / Letter

---

```
+------------------------------------------------------------------------+
| Estudio: Predictor institucional de ypN0 tras NAC                      |
| Study:   Institutional ypN0 predictor after NAC                        |
| PI: Dr. Sergio Cervera                                                 |
| Versión / Version: 1.0  —  Fecha / Date: 2026-05-14                    |
+------------------------------------------------------------------------+

ID hashed (record_id): __________________   Abstractora / Abstractor: ____
Fecha abstracción / Abstraction date: ____ / ____ / ______
QC reviewer (initials): ______       QC date: ____ / ____ / ______
```

---

## A. DEMOGRAFÍA / DEMOGRAPHICS

| Campo / Field | Valor / Value |
|---|---|
| Fecha diagnóstico / Dx date | ____ / ____ / ______ |
| Edad al diagnóstico / Age at dx (años) | ____ |
| Sexo / Sex | [ ] F  [ ] M |
| BMI (kg/m²) | ____ |
| ECOG | [ ] 0  [ ] 1  [ ] 2  [ ] 3  [ ] 4 |
| Estado menopáusico / Menopausal | [ ] Pre  [ ] Peri  [ ] Post  [ ] ? |
| Comorbilidades / Comorbidities | [ ] DM  [ ] HTA  [ ] CV  [ ] Otra: ______ |
| Tabaquismo / Smoking | [ ] Nunca  [ ] Ex  [ ] Activo  [ ] ? |
| Hist. familiar 1er grado / FH | [ ] Sí  [ ] No |
| BRCA1/2 | [ ] WT  [ ] BRCA1  [ ] BRCA2  [ ] VUS  [ ] No testado |

---

## B. TUMOR BASAL / BASELINE TUMOR

| Campo | Valor |
|---|---|
| Lateralidad / Laterality | [ ] D  [ ] I  [ ] Bilat |
| Cuadrante / Quadrant | [ ] CSE  [ ] CSI  [ ] CIE  [ ] CII  [ ] Central  [ ] Multifocal |
| Tamaño imagen / Imaging size (mm) | ____ |
| cT (AJCC 8) | [ ] T1  [ ] T2  [ ] T3  [ ] T4a  [ ] T4b  [ ] T4c  [ ] T4d |
| cN (AJCC 8) | [ ] N1  [ ] N2  [ ] N3a  [ ] N3b  [ ] N3c |
| Histología / Histology | [ ] CDI NST  [ ] CLI  [ ] Mixto  [ ] Mucinoso  [ ] Tubular  [ ] Otro: ______ |
| Grado / Grade (Nottingham) | [ ] G1  [ ] G2  [ ] G3 |
| ER (%) | [ ] Neg (<1%)   [ ] Pos: ____ % |
| PR (%) | [ ] Neg (<1%)   [ ] Pos: ____ % |
| HER2 IHC | [ ] 0  [ ] 1+  [ ] 2+  [ ] 3+ |
| HER2 ISH (si IHC 2+) | [ ] No amplificado  [ ] Amplificado  [ ] No realizado |
| Ki67 (%) | ____ |
| Subtipo / Subtype | [ ] Luminal A  [ ] Luminal B HER2-  [ ] Luminal B HER2+  [ ] HER2+ no luminal  [ ] TNBC |
| Oncotype DX RS (si aplica) | ____ |

---

## C. EVALUACIÓN AXILAR INICIAL / INITIAL NODAL ASSESSMENT

| Campo | Valor |
|---|---|
| Adenopatía palpable / Palpable node | [ ] Sí  [ ] No |
| Eco axilar realizada / Axillary US | [ ] Sí  [ ] No  → si Sí: # sospechosos: ____ |
| Tipo biopsia ganglio / Nodal biopsy | [ ] FNA  [ ] BAG  [ ] Ambos  [ ] Ninguno |
| Resultado biopsia / Biopsy result | [ ] Pos  [ ] Neg  [ ] Inadecuado |
| **Clip colocado** / Clip placed | [ ] Sí  [ ] No  ← *crítico para TAD* |
| PET/CT basal / Baseline PET | [ ] Sí  [ ] No  → si Sí: # FDG-ávidos: ____ |
| RM mama basal / Baseline MRI | [ ] Sí  [ ] No  → si Sí: # ganglios sospechosos: ____ |

> **Skip pattern:** si "Adenopatía palpable" + biopsia = Neg ⇒ excluir paciente (cN0 verdadero).

---

## D. NEOADYUVANCIA / NAC

| Campo | Valor |
|---|---|
| Fecha inicio NAC / NAC start | ____ / ____ / ______ |
| Régimen / Regimen | [ ] AC-T  [ ] TC  [ ] TCH  [ ] TCHP  [ ] KEYNOTE-522  [ ] Carbo-taxano  [ ] Otro: ______ |
| Antraciclina / Anthracycline | [ ] Sí  [ ] No |
| Taxano / Taxane | [ ] Sí  [ ] No |
| Carboplatino / Carboplatin | [ ] Sí  [ ] No |
| Trastuzumab (si HER2+) | [ ] Sí  [ ] No  [ ] N/A |
| Pertuzumab (si HER2+) | [ ] Sí  [ ] No  [ ] N/A |
| Pembrolizumab (si TNBC) | [ ] Sí  [ ] No  [ ] N/A |
| Hormono-NAC añadida | [ ] Sí  [ ] No |
| Ciclos planificados / Planned | ____ |
| Ciclos recibidos / Received | ____ |
| Reducción dosis / Dose reduction | [ ] Sí  [ ] No |
| Toxicidad máx. CTCAE | [ ] G1  [ ] G2  [ ] G3  [ ] G4  [ ] G5 |
| Fecha fin NAC / NAC end | ____ / ____ / ______ |

---

## E. RESTAGING POST-NAC

| Campo | Valor |
|---|---|
| Respuesta clínica mama (RECIST) | [ ] CR  [ ] PR  [ ] SD  [ ] PD |
| Respuesta clínica axila | [ ] CR  [ ] PR  [ ] SD  [ ] PD |
| Eco post-NAC realizada | [ ] Sí  [ ] No  → si Sí: ¿Persiste sospecha? [ ] Sí  [ ] No |
| RM post-NAC realizada | [ ] Sí  [ ] No  → si Sí: tamaño residual ____ mm |

---

## F. CIRUGÍA / SURGERY

| Campo | Valor |
|---|---|
| Fecha cirugía / Surgery date | ____ / ____ / ______ |
| Cirugía mama / Breast surgery | [ ] Conservadora  [ ] Mastectomía  [ ] Mast + recon |
| **Cirugía axilar** / Axillary surgery | [ ] SLNB sola  [ ] **TAD**  [ ] ALND sola  [ ] SLNB+ALND  [ ] TAD+ALND |
| Trazador dual / Dual tracer (Tc + colorante/ICG) | [ ] Sí  [ ] No |
| # SLNs examinados | ____ |
| Clip recuperado / Clip retrieved | [ ] Sí  [ ] No  [ ] N/A |
| Clip era SLN / Clip was SLN | [ ] Sí  [ ] No  [ ] N/A |
| IHC realizada / IHC performed (citoqueratina) | [ ] Sí  [ ] No |

---

## G. ANATOMÍA PATOLÓGICA FINAL / FINAL PATHOLOGY

| Campo | Valor |
|---|---|
| ypT (AJCC 8) | [ ] T0  [ ] Tis  [ ] T1mi  [ ] T1a  [ ] T1b  [ ] T1c  [ ] T2  [ ] T3  [ ] T4 |
| **ypN (AJCC 8)** | [ ] **N0**  [ ] **N0(i+)**  [ ] N1mi  [ ] N1  [ ] N2  [ ] N3 |
| **OUTCOME PRIMARIO ypN0** (auto: N0 o N0(i+)) | [ ] **Sí**  [ ] **No** |
| Total ganglios examinados | ____ |
| Total ganglios positivos | ____ |
| ITC presentes / ITC present | [ ] Sí  [ ] No |
| Tamaño residual mama (mm) | ____ |
| RCB clase / RCB class | [ ] RCB-0 (pCR)  [ ] RCB-I  [ ] RCB-II  [ ] RCB-III |
| RCB índice numérico | ____ |

---

## H. ADYUVANCIA / ADJUVANT

| Campo | Valor |
|---|---|
| RT adyuvante / Adjuvant RT | [ ] Sí  [ ] No |
| RT regional incluida | [ ] Sí  [ ] No  [ ] N/A |
| QT adyuvante / Adjuvant chemo | [ ] Sí  [ ] No |
| Capecitabina (CREATE-X) | [ ] Sí  [ ] No |
| T-DM1 (KATHERINE, si HER2+) | [ ] Sí  [ ] No  [ ] N/A |
| Pembrolizumab adyuvante (si TNBC) | [ ] Sí  [ ] No  [ ] N/A |
| Hormono adyuvante / Endocrine | [ ] Sí  [ ] No  [ ] N/A |
| Olaparib (OlympiA, si BRCA) | [ ] Sí  [ ] No  [ ] N/A |

---

## I. EVOLUCIÓN / OUTCOMES

| Campo | Valor |
|---|---|
| Fecha último seguimiento / Last FU | ____ / ____ / ______ |
| **Recidiva axilar** / Axillary recurrence | [ ] Sí  [ ] No  → fecha: ____ / ____ / ______ |
| Recidiva locorregional | [ ] Sí  [ ] No  → fecha: ____ / ____ / ______ |
| Recidiva distancia / Distant | [ ] Sí  [ ] No  → fecha: ____ / ____ / ______ |
| Estado vital / Vital status | [ ] Vivo  [ ] Muerto-CM  [ ] Muerto-otra causa  [ ] ? |
| Fecha defunción (si aplica) | ____ / ____ / ______ |

---

## J. METADATOS / METADATA

| Campo | Valor |
|---|---|
| Fuente de datos / Data source | [ ] HCIS  [ ] AP  [ ] RT  [ ] Externo |
| Variables críticas faltantes / Critical missing vars | __________________________________ |
| Notas / Notes | __________________________________ |

---

## K. SIGN-OFF

```
+------------------------------------------------------------------------+
| Abstractora / Abstractor:                                              |
|   Nombre / Name: ________________________  Firma / Sign: ____________  |
|   Fecha / Date: ____ / ____ / ______                                   |
|                                                                        |
| QC Reviewer:                                                           |
|   Nombre / Name: ________________________  Firma / Sign: ____________  |
|   Fecha / Date: ____ / ____ / ______                                   |
|   Discrepancias resueltas / Discrepancies resolved: [ ] Sí  [ ] No     |
|                                                                        |
| PI (Dr. Sergio Cervera):                                               |
|   Firma / Sign: ____________   Fecha / Date: ____ / ____ / ______      |
+------------------------------------------------------------------------+
```

---

### Notas de uso / Usage notes

- **Skip critical:** si paciente no recibió NAC ⇒ excluir; si cN0 inicial ⇒ excluir.
- **Variables OBLIGATORIAS** (marcadas en negrita) no pueden quedar en blanco; si faltan,
  documentar en sección J y derivar al PI.
- Imprimir en A4 (1 hoja por paciente; secciones A-J en 2 columnas si es necesario).
- Tras llenar a mano, transcribir a REDCap dentro de las 48 h siguientes.
- El PDF firmado se archiva en carpeta segura institucional (no se guarda en repositorio).
