Breast CancerNEORISKNCT06441240
Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy.
An observational study of Breast Cancer and Chemotherapy Effect, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy Effect, Triple Negative Breast Cancer
- What is being tested?
- MRI
- How many people
- 933 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 30 Mar 2026
- 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: All patients with breast cancer (Stage I, II, and III) undergoing NACT at our center between January 2014 and June 2021 will be included, for an estimated total of 933 patients.
Who may be able to join
- Histological diagnosis of locally advanced Luminal or HER2+ or Triple-negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage of disease from I to III.
- Patient undergoing neoadjuvant chemotherapy treatment from January 1, 2014, to June 30, 2021.
- Age > 18 years
- Availability of clinical data, staging MRI diagnostic images (for the radiomic sub-study), and biomolecular data.
Who cannot join
- Previous or synchronous history of systemic malignancies.
- History of ipsilateral or contralateral breast neoplasia.
- Evidence of metastatic disease (Stage IV).
- Neoadjuvant treatment with hormone therapy.
- Patients with unavailable or low-quality MRI images that did not allow lesion identification (for the radiomic study only).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli - IRCCS
Roma
Alessandra Fabi, +390630153773, alessandra.fabi@policlinicogemelli.it
Alessandra Fabi, +390630155701, alessandra.fabi@policlinicogemelli.it
About this study
Official title: Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy. The NEORISK Study.
INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Currently, the treatment for these patients involves initial neoadjuvant chemotherapy (NACT) followed by surgical treatment. In recent years, NACT has also been used for highly chemoresponsive tumors such as triple-negative (TN) and HER2-positive (HER2+) breast cancer.
The widespread use of NACT has led to additional benefits, including downstaging of breast and axillary neoplasms, resulting in reduced morbidity; improved cosmetic outcomes due to increased use of conservative interventions; and personalized adjuvant chemotherapy treatment. Several studies have shown that response to chemotherapy predicts better systemic outcomes. Complete pathological response (pCR), defined as the absence of invasive neoplastic residue in the surgical specimen, has been predictive of better distant outcomes. Limited evidence exists regarding other predictive factors for distant outcomes.
Read more
Given the significant impact of disease recurrence on patient prognosis, efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse. In this context, the term "Early Disease Recurrence" (EDR) has been coined to define the occurrence of disease recurrence, both locally and distantly, within 3 years after completing treatment.
In recent years, the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated. Specifically, radiomic features obtained from Magnetic Resonance Imaging (MRI) images appear capable of predicting tumor receptor status, differentiating tumor subtypes, and predicting response to NACT.
Although the role of radiomics in predicting recurrence has been investigated, research is still in its early stages, and there are variations in technology and methodology for extracting radiomic features. Additionally, to date, no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT.
- Conditions
- Breast Cancer, Chemotherapy Effect, Triple Negative Breast Cancer, Recurrence, Local Neoplasm, Risk Factors
- Being tested
- MRI
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Breast MRI
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients underwent neoadjuvant chemotherapy | Patients undergoing neoadjuvant chemotherapy and subsequent surgical treatment. Patients must have undergone radiological evaluation by MRI at the beginning and end of chemotherapy treatment Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of molecular subtypes
Frequency of molecular subtypes (Her2 positive, hormone receptor-positive/Her2 negative, Triple Negative) in the considered cases
Measured: 7 years
Association between radiomic features and risk of recurrence
Association between radiomic features extracted from pre-operative MRI and the onset of disease recurrence within 3 years from the end of neoadjuvant treatment
Measured: 7 years
Secondary outcomes (7)
Association between chemotherapy and neoplastic characteristics
Evaluate whether clinical features (divided into: age assessed in years, menopausal status divided into menopausal or fertile age), radiological features such as initial extent of disease and lymph node involvement at diagnosis) and biomolecular features (such as histotype: divided into ductal, lobular or nonspecial type, grading, hormone receptor status) influence response to neoadjuvant chemotherapy
Translated with DeepL.com (free version)
Measured: 7 years
Evaluation of radiological response
Frequency of radiological response according to molecular subtype, treatment, type of imaging examination used, and initial staging.
Measured: 7 years
Frequency of complete pathological response
Frequency of complete pathological response according to molecular subtype, treatment, and initial staging.
Measured: 7 years
Description of surgical treatment according to the cancer characteristics
Frequency of surgical procedures based on radiological response, molecular subtypes, and initial staging.
Measured: 7 years
Description of adjuvant treatments
Frequency of adjuvant therapies based on neoadjuvant treatment, molecular subtypes, and initial staging.
Measured: 7 years
Evaluation of oncological outcomes
Disease-free survival (DFS) measured from the start of neoadjuvant therapy to the first evidence of disease recurrence or death, whichever occurs first.
Measured: 7 years
Assessment of risk of recurrence using models
Accuracy of pure models (radiomic/clinical/radiological) and combined models in predicting disease recurrence within 3 years from the end of neoadjuvant treatment
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 933 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Fabi, Principal investigator, Policlinico Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441240
- Sponsor's protocol ID
- 6081
- Acronym
- NEORISK
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Antonio F, Carbognin L, Paris I, Di Leone A, Orlandi A, Marazzi F, Mule A, Belli P, Rossi A, Magno S, Palazzo A, Masiello V, Santoro A, Fuso P, Bria E, D'Archi S, Scardina L, Sanchez AM, Giannarelli D, Paternello S, Garganese G, Scambia G, Tortora G, Masetti R, Franceschini G, Fabi A. Predictive risk factors of recurrence in breast cancer after neoadjuvant treatment: the NEORISK study. Future Oncol. 2025 Jul;21(17):2215-2223. doi: 10.1080/14796694.2025.2516410. Epub 2025 Jun 14.
PubMed 40515524
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy. The NEORISK Study.
- ClinicalTrials.gov ID
- NCT06441240
- Acronym / sponsor ID
- NEORISK / 6081
- Conditions
- Breast Cancer, Chemotherapy Effect, Triple Negative Breast Cancer, Recurrence, Local Neoplasm, Risk Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 933 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 4 Jun 2024 (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.
INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Currently, the treatment for these patients involves initial neoadjuvant chemotherapy (NACT) followed by surgical treatment. In recent years, NACT has also been used for highly chemoresponsive tumors such as triple-negative (TN) and HER2-positive (HER2+) breast cancer.
The widespread use of NACT has led to additional benefits, including downstaging of breast and axillary neoplasms, resulting in reduced morbidity; improved cosmetic outcomes due to increased use of conservative interventions; and personalized adjuvant chemotherapy treatment. Several studies have shown that response to chemotherapy predicts better systemic outcomes. Complete pathological response (pCR), defined as the absence of invasive neoplastic residue in the surgical specimen, has been predictive of better distant outcomes. Limited evidence exists regarding other predictive factors for distant outcomes.
Given the significant impact of disease recurrence on patient prognosis, efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse. In this context, the term "Early Disease Recurrence" (EDR) has been coined to define the occurrence of disease recurrence, both locally and distantly, within 3 years after completing treatment.
In recent years, the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated. Specifically, radiomic features obtained from Magnetic Resonance Imaging (MRI) images appear capable of predicting tumor receptor status, differentiating tumor subtypes, and predicting response to NACT.
Although the role of radiomics in predicting recurrence has been investigated, research is still in its early stages, and there are variations in technology and methodology for extracting radiomic features. Additionally, to date, no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients underwent neoadjuvant chemotherapy | – | Diagnostic Test: MRIPatients undergoing neoadjuvant chemotherapy and subsequent surgical treatment. Patients must have undergone radiological evaluation by MRI at the beginning and end of chemotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with breast cancer (Stage I, II, and III) undergoing NACT at our center between January 2014 and June 2021 will be included, for an estimated total of 933 patients.
Key inclusion criteria (4 listed)
- Histological diagnosis of locally advanced Luminal or HER2+ or Triple-negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage of disease from I to III.
- Patient undergoing neoadjuvant chemotherapy treatment from January 1, 2014, to June 30, 2021.
- Age > 18 years
- Availability of clinical data, staging MRI diagnostic images (for the radiomic sub-study), and biomolecular data.
Key exclusion criteria (5 listed)
- Previous or synchronous history of systemic malignancies.
- History of ipsilateral or contralateral breast neoplasia.
- Evidence of metastatic disease (Stage IV).
- Neoadjuvant treatment with hormone therapy.
- Patients with unavailable or low-quality MRI images that did not allow lesion identification (for the radiomic study only).
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 |
|---|---|---|
| MRIBreast MRI | Diagnostic test | Breast cancer patients underwent neoadjuvant chemotherapy |
Primary outcome
Description of molecular subtypes
Time frame: 7 years
Frequency of molecular subtypes (Her2 positive, hormone receptor-positive/Her2 negative, Triple Negative) in the considered cases
Association between radiomic features and risk of recurrence
Time frame: 7 years
Association between radiomic features extracted from pre-operative MRI and the onset of disease recurrence within 3 years from the end of neoadjuvant treatment
7 secondary outcomes
Association between chemotherapy and neoplastic characteristics
Time frame: 7 years
Evaluation of radiological response
Time frame: 7 years
Frequency of complete pathological response
Time frame: 7 years
Description of surgical treatment according to the cancer characteristics
Time frame: 7 years
Description of adjuvant treatments
Time frame: 7 years
Evaluation of oncological outcomes
Time frame: 7 years
Assessment of risk of recurrence using models
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 40515524Antonio F, Carbognin L, Paris I, Di Leone A, Orlandi A, Marazzi F, Mule A, Belli P, Rossi A, Magno S, Palazzo A, Masiello V, Santoro A, Fuso P, Bria E, D'Archi S, Scardina L, Sanchez AM, Giannarelli D, Paternello S, Garganese G, Scambia G, Tortora G, Masetti R, Franceschini G, Fabi A. Predictive risk factors of recurrence in breast cancer after neoadjuvant treatment: the NEORISK study. Future Oncol. 2025 Jul;21(17):2215-2223. doi: 10.1080/14796694.2025.2516410. Epub 2025 Jun 14.
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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.
Alessandra Fabi principal investigator
Policlinico Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy Effect, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Fabi (0630157337, alessandra.fabi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of molecular subtypes (time frame: 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441240, which also lists 1 linked publication.
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 4 Jun 2024.