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ENDO-67 project: Investigating ENDOcrine therapy-related questions using Ki67 changes in the window-of-opportunity before breast surgery

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521385-10-00
Enrollment
175
Registered
2025-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-21

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

Conditions

Breast cancer

Brief summary

Endoxifen levels after three months of continuous use of 20mg (standard dose) of tamoxifen, Tamoxifen resistance defined as Ki67 >10% after three weeks of tamoxifen use according to an adequate dosing schedule, Intratumoral endoxifen levels after three weeks and Ki67 response defined as difference between Ki67 percentage for and Ki67 percentage after three weeks of tamoxifen according to an adequate dosing schedule

Detailed description

Ki67 percentages on tumor material, Levels on estradiol and progesterone in blood after three weeks and three months of tamoxifen treatment, Ki67 percentages on tumor material measured by the pathologist and measured by an AI algorithm, Change in scores of the FACT-ES questionnaire

Interventions

DRUGTAMOXIFEN

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Endoxifen levels after three months of continuous use of 20mg (standard dose) of tamoxifen, Tamoxifen resistance defined as Ki67 >10% after three weeks of tamoxifen use according to an adequate dosing schedule, Intratumoral endoxifen levels after three weeks and Ki67 response defined as difference between Ki67 percentage for and Ki67 percentage after three weeks of tamoxifen according to an adequate dosing schedule

Secondary

MeasureTime frame
Ki67 percentages on tumor material, Levels on estradiol and progesterone in blood after three weeks and three months of tamoxifen treatment, Ki67 percentages on tumor material measured by the pathologist and measured by an AI algorithm, Change in scores of the FACT-ES questionnaire

Countries

Netherlands

Outcome results

None listed

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