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PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

NCT04584853 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Breast Cancer Female

Interventions

DRUG

Abemaciclib

Abemaciclib used in combination with standard Endocrine Therapy for 2 years from randomisation

DRUG

Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen)

Standard of care endocrine therapy for a minimum of 5 years from randomisation

Sponsors & Collaborators

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Stephen Johnston · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2030-10-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584853 on ClinicalTrials.gov