Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy

NCT ID: NCT05213403

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient G1

Correlation between surgery and scoring system

Evaluation with new scoring system

Intervention Type DIAGNOSTIC_TEST

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

Evaluation with new scoring system

Intervention Type DIAGNOSTIC_TEST

Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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FABI ALESSANDRA

Dr.ssa

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluca Franceschini, Prof.

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico Agostino Gemelli - Roma

Other Identifiers

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4694

Identifier Type: -

Identifier Source: org_study_id

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