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| Name | Class |
|---|---|
| Clinical Research Technology S.r.l. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Technology | Contact | 0039 089 301545 | perseverex@cr-technology.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonella Palazzo | Fondazione Policlinico Gemelli, IRCCS | Principal Investigator |
| Alessandra Fabi | Fondazione Policlinico Gemelli, IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Technology | Salerno | Italy |
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| up to 30 months |