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CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.
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| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS of HR+/HER2- breast cancer patients who received endocrine treatment plus CDK4/6 inhibitor as first line treatment for metastatic disease, categorized according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative). | Through study completion, an average of 1 year". |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative). | Through study completion, an average of 1 year". |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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HR+/HER2- advanced breast cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Fabi, MD | Contact | 0039 0630157337 | alessandra.fabi@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandra Fabi, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico A. Gemelli - IRCCS | Recruiting | Rome | 00168 | Italy |
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OS according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
| Through study completion, an average of 1 year". |
| Incidence of Adverse Events (AEs) | AEs related to the treatment and evaluated according to CTCAE v5.0 | Through study completion, an average of 1 year". |