Breast Cancer Early Stage Breast Cancer (Stage 1-3)PERSEVEREXNCT06807749
Adjuvant Treatment in Premenopausal Breast Cancer
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- How many people
- 800 participants
- Where
- 2 sitesItaly
- Study dates
- 24 Dec 2025to Sep 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients with premenopausal early breast cancer HR+ HER2 negative diagnosis with any Recurrence Score (RS) and pathological nodal status pN0/pN1 and who underwent the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
Who may be able to join
- Female, premenopausal and ≥18 years age patients.
- Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable
- Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative.
- Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3.
- Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
- Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022
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- Availability of clinical and pathological information.
- Availability of information about adjuvant treatment received.
- Availability of patient' outcome information (relapse, site of relapse, survival).
Who cannot join
- Evidence of distant metastases
- Inflammatory breast cancer
- Neoadjuvant treatment
- No surgery for primary breast cancer and axillary staging
- Patients not tested with 21-multigene assay Oncotype DX
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione Policlinico Gemelli
Roma, Antonella Palazzo
Antonella Palazzo MD, 0039 0630155202, antonella.palazzo@policlinicogemelli.it
Antonella Palazzo
- Not yet recruiting
Clinical Research Technology
Salerno
Clinical Research Technology, 0039 089 301545, perseverex@cr-technology.com
About this study
Official title: PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test
Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
Read the detailed description
Premenopausal patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 with any Recurrence Score (RS) and pathological nodal status pN0/pN1 will be included in the study. The study will collect clinical-pathological, genomic characteristics, adjuvant treatments (chemotherapy, endocrine therapy with/without OFS), and survival outcome (iDFS).
- Keywords
- Premenopausal early breast cancer, Oncotype Dx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| node negative (pN0) | Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test | |
| node positive (pN1) | Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival (iDFS) at 5 years
The primary endpoint of the study will be the invasive Disease-Free Survival (iDFS) at 5 years among pN0 and pN1 premenopausal breast cancer patients in subgroups formed according to their genomic risk according to 21- multigene assay Oncotype DX.
Measured: up to 30 months
Secondary outcomes (1)
To describe the effect of the different adjuvant treatments according to clinical and genomic risk
Descriptive statistics, statistical measure of association, and logistic binomial regression modeling of the association measures between the iDFS at 5 years and explicative variables including adjuvant treatment received (chemo/endocrine therapy; endocrine therapy with or without OSF), pathological tumor status, and genomic risk score according to 21-multigene assay Oncotype DX.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start24 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Technology S.r.l.
- Responsible party
- Sponsor
- Investigators
- Antonella Palazzo, Principal investigator, Fondazione Policlinico Gemelli, IRCCSAlessandra Fabi, Study chair, Fondazione Policlinico Gemelli, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807749
- Sponsor's protocol ID
- 7296
- Acronym
- PERSEVEREX
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test
- ClinicalTrials.gov ID
- NCT06807749
- Acronym / sponsor ID
- PERSEVEREX / 7296
- Keywords
- Premenopausal early breast cancer, Oncotype Dx
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Clinical Research Technology S.r.l.
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Feb 2025 (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.
Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
Detailed description
Premenopausal patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 with any Recurrence Score (RS) and pathological nodal status pN0/pN1 will be included in the study. The study will collect clinical-pathological, genomic characteristics, adjuvant treatments (chemotherapy, endocrine therapy with/without OFS), and survival outcome (iDFS).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| node negative (pN0) | – | –Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test |
| node positive (pN1) | – | –Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with premenopausal early breast cancer HR+ HER2 negative diagnosis with any Recurrence Score (RS) and pathological nodal status pN0/pN1 and who underwent the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
Key inclusion criteria (9 listed)
- Female, premenopausal and ≥18 years age patients.
- Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable
- Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative.
- Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3.
- Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
Key exclusion criteria (5 listed)
- Evidence of distant metastases
- Inflammatory breast cancer
- Neoadjuvant treatment
- No surgery for primary breast cancer and axillary staging
- Patients not tested with 21-multigene assay Oncotype DX
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Invasive Disease-Free Survival (iDFS) at 5 years
Time frame: up to 30 months
The primary endpoint of the study will be the invasive Disease-Free Survival (iDFS) at 5 years among pN0 and pN1 premenopausal breast cancer patients in subgroups formed according to their genomic risk according to 21- multigene assay Oncotype DX.
1 secondary outcome
To describe the effect of the different adjuvant treatments according to clinical and genomic risk
Time frame: up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Antonella Palazzo principal investigator
Fondazione Policlinico Gemelli, IRCCS
Alessandra Fabi study chair
Fondazione Policlinico Gemelli, IRCCS
2 sites 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 Early Stage Breast Cancer (Stage 1-3), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites 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 9 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Technology (0039 089 301545, perseverex@cr-technology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease-Free Survival (iDFS) at 5 years (time frame: up to 30 months). 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 3 Sep 2026.