Clinical Trial: NCT04584853
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Institute of Cancer Research, United Kingdom |
| Information Provided By: | Institute of Cancer Research, United Kingdom |
| Last Update Posted: | 2026-01-14 |
Study Overview
Brief Summary
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery. Eligible patients will be randomised to standard adjuvant endocrine therapy alone or standard adjuvant endocrine therapy with a CDK4/6 inhibitor called abemaciclib.
Official Title
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
Conditions
Breast Cancer Female
Intervention / Treatment
- Drug: Abemaciclib
- Drug: Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen)
Other Study ID Numbers
- ICRCTSU/2019/10068
Start Date (Actual)
2020-12-23
Primary Completion Date (Estimated)
2030-10
Study Completion Date (Estimated)
2030-10
Enrollment (Actual)
123
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Institute of Cancer Research, United Kingdom |
| Information Provided By: | Institute of Cancer Research, United Kingdom |
| Last Update Posted: | 2026-01-14 |
Study Overview
Brief Summary
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery. Eligible patients will be randomised to standard adjuvant endocrine therapy alone or standard adjuvant endocrine therapy with a CDK4/6 inhibitor called abemaciclib.
Official Title
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
Conditions
Breast Cancer Female
Intervention / Treatment
- Drug: Abemaciclib
- Drug: Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen)
Other Study ID Numbers
- ICRCTSU/2019/10068
Start Date (Actual)
2020-12-23
Primary Completion Date (Estimated)
2030-10
Study Completion Date (Estimated)
2030-10
Enrollment (Actual)
123
Study Type
Interventional
Phase
Phase 3