Study Results
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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NOT_YET_RECRUITING
800 participants
OBSERVATIONAL
2025-04-30
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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node negative (pN0)
Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test
No interventions assigned to this group
node positive (pN1)
Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable
3. Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative.
4. Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3.
5. Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
6. Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022
7. Availability of clinical and pathological information.
8. Availability of information about adjuvant treatment received.
9. Availability of patient' outcome information (relapse, site of relapse, survival).
Exclusion Criteria
2. Inflammatory breast cancer
3. Neoadjuvant treatment
4. No surgery for primary breast cancer and axillary staging
5. Patients not tested with 21-multigene assay Oncotype DX
60 Years
FEMALE
No
Sponsors
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Clinical Research Technology S.r.l.
INDUSTRY
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Antonella Palazzo
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Gemelli, IRCCS
Alessandra Fabi
Role: STUDY_CHAIR
Fondazione Policlinico Gemelli, IRCCS
Locations
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Clinical Research Technology
Salerno, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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7296
Identifier Type: -
Identifier Source: org_study_id
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