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JBCRG-24 (PALLAS)
GLOBAL PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone rec
PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone rec
- Status
- No Longer Recruiting
- Objectives
- To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC).
- Subjects
- Endpoints
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Primary Endpoint
(1) Invasive disease-free survival (iDFS) defined according to STEEP criteria.
Secondary Endpoints
(1) Invasive disease-free survival (iDFS) excluding second primary 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 according to STEEP criteria as the composite of distant recurrence or death from any cause.
(5) Adverse Events
- Trial Period
- August 2015- Sep. 2020 (Estimate)
- Lead Principal Investigator
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Global: Monica Bertagnolli (Alliance Foundation), Erica Mayer (Dana-Farber), Angela DeMichele (Univ of Pennsylvania), Michael Gnant (ABCSG).
Japan: Dr. Hiroji Iwata （Aichi Cancer Center Hospital)
- Target Sample Size
- 4600（Global), 50 (Japan)
- Regimen
- palbociclib 125 mg vs Placebo
- Source of Funding
- ABCSG, Alliance Foundation Trials, LLC.
- Conference Presentation
- Articles and Publications
- Memo
- COI Disclosure