BreastNESSy: Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy
Study Details
Study Description
Brief Summary
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:
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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.
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Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases.
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Overall survival (OS): months from the start of NACT to death or last follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patient G1 Correlation between surgery and scoring system |
Diagnostic Test: Evaluation with new scoring system
Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes
|
| Patients G2 Incongruence between surgery and scoring system |
Diagnostic Test: Evaluation with new scoring system
Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes
|
Outcome Measures
Primary Outcome Measures
- Development of a new scoring system [2016-2021]
Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients
Secondary Outcome Measures
- Evaluation of outcome disease [2016-2021]
Capacity of the new score system to avoid loco-regional disease; Distant disease and Overall survival.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing neoadjuvant chemotherapy
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Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)
Exclusion Criteria:
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lack of initial staging or restaging;
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previous or synchronous history of systemic malignant neoplasms.
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history of homo-or contralateral breast cancer.
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initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (Stage IV)
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indication to modified radical mastectomy (MRM) without delayed reconstruction
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Gianluca Franceschini, Prof., IRCCS Policlinico Agostino Gemelli - Roma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4694