Clinical trial · Observational
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
NCT04021069CI-TRIAL-00039499unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Invasive Ductal Breast Carcinoma | Invasive Breast Carcinoma of No Special Type | ALIAS | 0.90 |
| Invasive Lobular Breast Carcinoma | Invasive Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiomic, pathomic, and clinical markers | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathologic complete response (pCR)
- timeFrame
- Up to 60 months
- description
- Evaluating the degree of absence of residual cancer cells
Secondary outcomes (3)
- measure
- Time to local breast recurrence
- timeFrame
- Up to 60 months
- description
- Evaluating the time until a recurrence event has occurred in the breast
- measure
- Time to distant metastasis (months)
- timeFrame
- Up to 60 months
- description
- Evaluating onset of distant metastasis
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be men and women age 18+ * Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-) * Any state of disease as described by AJCC v7 criteria * Participants must have received and completed neoadjuvant chemotherapy Exclusion Criteria: * Participants who had other primary cancers prior to breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.