To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-early breast cancer.
Conditions
Brief summary
Invasive disease-free survival (iDFS) defined acc. to STEEP criteria
Detailed description
(1) Invasive disease-free survival (iDFS) excl. second primary invasive cancers of non-breast origin as an event., (2) Overall Survival (OS), (3) Locoregional recurrences-free survival (LRRFS) defined as the composite of local/regional ipsilateral recurrence, contralateral invasive breast cancer or death from any cause, (4) Distant recurrence free survival (DRFS) is defined acc. to STEEP criteria as the composite of distant recurrence or death from any cause., (5) Adverse Events
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival (iDFS) defined acc. to STEEP criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Invasive disease-free survival (iDFS) excl. second primary invasive cancers of non-breast origin as an event., (2) Overall Survival (OS), (3) Locoregional recurrences-free survival (LRRFS) defined as the composite of local/regional ipsilateral recurrence, contralateral invasive breast cancer or death from any cause, (4) Distant recurrence free survival (DRFS) is defined acc. to STEEP criteria as the composite of distant recurrence or death from any cause., (5) Adverse Events | — |
Countries
Austria, Belgium, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden