Clinical trial · Observational
Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy
Innovative "Scoring System" in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy
- 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)
Our aim is to create a Scoring System (SS) able of guaranteeing radical oncology by completely removing cancer and aesthetic outcomes in line with the needs or expectations of the patients that helps surgeons to decide the type of surgery in patients undergoing NACT. Secondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating: * Loco-regional disease free-survival (LR-DFS): months between start of NACT and date of a neoplastic recurrence in residual mammary gland, in ipsilateral chest wall or in ipsilateral axilla. * Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases. * Overall survival (OS): months from the start of NACT to death or last follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation with new scoring system | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patient G1
- description
- Correlation between surgery and scoring system
- interventionNames
- Diagnostic Test: Evaluation with new scoring system
- label
- Patients G2
- description
- Incongruence between surgery and scoring system
- interventionNames
- Diagnostic Test: Evaluation with new scoring system
Primary outcomes (1)
- measure
- Development of a new scoring system
- timeFrame
- 2016-2021
- description
- Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing neoadjuvant chemotherapy * Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM) Exclusion Criteria: * lack of initial staging or restaging; * previous or synchronous history of systemic malignant neoplasms. * history of homo-or contralateral breast cancer. * initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (Stage IV) * indication to modified radical mastectomy (MRM) without delayed reconstruction
References
Publications (0)
Data not yet available