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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 receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514841-12-00
Acronym
AFT-05/ABCSG-42/BIG_
Enrollment
2278
Registered
2024-07-17
Start date
2015-10-27
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-early breast cancer.

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

DRUGPalbociclib

Sponsors

ABCSG GmbH, Alliance Foundation Trials LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Invasive disease-free survival (iDFS) defined acc. to STEEP criteria

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026