Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate-risk, HR+/HER2- early breast cancer (ADAPTcycle)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515769-32-00

Acronym

WSG-AM08

Enrollment

1684

Registered

2024-10-01

Start date

2019-07-02

Completion date

Unknown

Last updated

2024-10-01

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 and dDFS

Detailed description

Overall survival (OS) and dDFS,, quality of life (QoL), treatment adherence (measured by drug intake),, local and central Ki-67 values in all tissue samples., Pathological response rate (defined as ypT0/is/ypN0), as well as further definitions (ypT0/ypN0; ypT0/is/any ypN, near pCR (ypT1a/any ypN)),, Clinical response rate (by palpation, ultrasound, and further methods),, Rate of breast-conservation therapy

Interventions

DRUGKisqali 200 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
iDFS and dDFS	—

Secondary

Measure	Time frame
Overall survival (OS) and dDFS,, quality of life (QoL), treatment adherence (measured by drug intake),, local and central Ki-67 values in all tissue samples., Pathological response rate (defined as ypT0/is/ypN0), as well as further definitions (ypT0/ypN0; ypT0/is/any ypN, near pCR (ypT1a/any ypN)),, Clinical response rate (by palpation, ultrasound, and further methods),, Rate of breast-conservation therapy	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

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