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Genomics guided targeted post-neoadjuvant therapy in patients with early breast cancer – a multicenter, open-label, umbrella phase-II study (COGNITION-GUIDE)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514022-23-00
Acronym
DKFZ-2019-008
Enrollment
240
Registered
2024-10-09
Start date
2023-06-23
Completion date
Unknown
Last updated
2025-11-27

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

Conditions

Early breast cancer

Brief summary

IDFS* of patients four years after surgery overall (*IDFS: time from surgery to whatever comes first a) ipsilateral invasive breast tumor recurrence, b) local/regional invasive breast cancer recurrence, c) distant recurrence, d) death attributable to any cause incl. breast cancer, e) contralateral invasive breast cancer or f) Second primary non-breast invasive cancer)

Detailed description

overall survival (OS), IDFS in each study arm separately, time from surgery to whatever comes first a) distant recurrence, b) death attributable to any cause incl. breast cancer or c) second primary non-breast invasive cancer, Safety including incidence of adverse events

Interventions

DRUGINAVOLISIB
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
DRUGLynparza 100 mg film-coated tablets
DRUGIpatasertib
DRUGLynparza 150 mg film-coated tablets
DRUGTecentriq 1 200 mg concentrate for solution for infusion

Sponsors

Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
IDFS* of patients four years after surgery overall (*IDFS: time from surgery to whatever comes first a) ipsilateral invasive breast tumor recurrence, b) local/regional invasive breast cancer recurrence, c) distant recurrence, d) death attributable to any cause incl. breast cancer, e) contralateral invasive breast cancer or f) Second primary non-breast invasive cancer)

Secondary

MeasureTime frame
overall survival (OS), IDFS in each study arm separately, time from surgery to whatever comes first a) distant recurrence, b) death attributable to any cause incl. breast cancer or c) second primary non-breast invasive cancer, Safety including incidence of adverse events

Countries

Germany

Outcome results

None listed

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