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Discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer with durable disease control: A randomized low-intervention phase II trial of the AIO working groups breast cancer and quality of life

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504141-31-00
Acronym
DISCUSS
Enrollment
120
Registered
2023-11-10
Start date
2024-01-17
Completion date
Unknown
Last updated
2025-07-08

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

Conditions

HER2 negative breast cancer, Metastatic HR positive

Brief summary

Progression-free survival rate 12 months after randomization (PFS@12_stopping), defined as proportion of patients alive and without progression according to radiologic imaging assessment

Interventions

DRUGEXEMESTANE
DRUGFULVESTRANT
DRUGPALBOCICLIB
DRUGLETROZOLE
DRUGABEMACICLIB
DRUGANASTROZOLE
DRUGRIBOCICLIB

Sponsors

Institut fuer Klinische Krebsforschung IKF GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free survival rate 12 months after randomization (PFS@12_stopping), defined as proportion of patients alive and without progression according to radiologic imaging assessment

Countries

Germany

Outcome results

None listed

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