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A randomized, controlled, open-label, phase III-trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) intermediate to high risk, HR+/HER2- early breast cancer (ADAPTlate)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509242-35-00
Acronym
WSG-AM11
Enrollment
1624
Registered
2023-12-08
Start date
2020-07-23
Completion date
Unknown
Last updated
2025-10-17

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

Conditions

HR+/HER2- early breast cancer

Brief summary

iDFS since randomization

Detailed description

iDFS since primary diagnosis, OS and dDFS since randomization, OS and dDFS since primary diagnosis, occurrence of CNS metastases since randomization, occurrence of CNS metastases since primary diagnosis, subgroup and multivariable survival analyses defined by key clinical, genomic, and endocrine response parameters, patient reported outcomes, quality of life (EORTC QLQ-C30, EORTC QLQ-BR23, EQ-5D-5L), Efficacy of therapy according to distinct clinical and biological (measured by genomic signatures and other markers) prognostic subgroups

Interventions

DRUGABEMACICLIB

Sponsors

WSG Westdeutsche Studiengruppe GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
iDFS since randomization—

Secondary

MeasureTime frame
iDFS since primary diagnosis, OS and dDFS since randomization, OS and dDFS since primary diagnosis, occurrence of CNS metastases since randomization, occurrence of CNS metastases since primary diagnosis, subgroup and multivariable survival analyses defined by key clinical, genomic, and endocrine response parameters, patient reported outcomes, quality of life (EORTC QLQ-C30, EORTC QLQ-BR23, EQ-5D-5L), Efficacy of therapy according to distinct clinical and biological (measured by genomic signatures and other markers) prognostic subgroups—

Countries

Germany, Poland, Spain

Outcome results

None listed

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