Early Breast CancerBreastNESSyNCT05213403
Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy
An observational study of Early Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- Evaluation with new scoring system
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing neoadjuvant chemotherapy subsequently subjected to conservative surgery (Quadrantectomy/lumpectomy), Oncoplastic surgery second level or conservative mastectomy with breast reconstruction
Who may be able to join
- Patients undergoing neoadjuvant chemotherapy
- Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)
Who cannot join
- 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
About this study
Official title: Innovative "Scoring System" in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy
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
- Early Breast Cancer
- Being tested
- Evaluation with new scoring system
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation with new scoring systemDiagnostic test
Evaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes
| Study group | Role | What they receive |
|---|---|---|
| Patient G1 | Correlation between surgery and scoring system Receives: Diagnostic Test: Evaluation with new scoring system | |
| Patients G2 | Incongruence between surgery and scoring system Receives: Diagnostic Test: Evaluation with new scoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a new scoring system
Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients
Measured: 2016-2021
Secondary outcomes (1)
Evaluation of outcome disease
Capacity of the new score system to avoid loco-regional disease; Distant disease and Overall survival.
Measured: 2016-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2016
- Primary completion31 Mar 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FABI ALESSANDRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Gianluca Franceschini, Prof., Principal investigator, IRCCS Policlinico Agostino Gemelli - Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213403
- Sponsor's protocol ID
- 4694
- Acronym
- BreastNESSy
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative "Scoring System" in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05213403
- Acronym / sponsor ID
- BreastNESSy / 4694
- Conditions
- Early Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient G1 | – | Diagnostic Test: Evaluation with new scoring systemCorrelation between surgery and scoring system |
| Patients G2 | – | Diagnostic Test: Evaluation with new scoring systemIncongruence between surgery and scoring system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing neoadjuvant chemotherapy subsequently subjected to conservative surgery (Quadrantectomy/lumpectomy), Oncoplastic surgery second level or conservative mastectomy with breast reconstruction
Key inclusion criteria (2 listed)
- Patients undergoing neoadjuvant chemotherapy
- Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation with new scoring systemEvaluate whether patients who have received surgery in line with the developed "scoring system" have a better aesthetic and oncological outcomes | Diagnostic test | Patient G1, Patients G2 |
Primary outcome
Development of a new scoring system
Time frame: 2016-2021
Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients
1 secondary outcome
Evaluation of outcome disease
Time frame: 2016-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Franceschini, Prof. principal investigator
IRCCS Policlinico Agostino Gemelli - Roma
Questions about this trial
What is this clinical trial studying?
An observational study of Early Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a new scoring system (time frame: 2016-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.