IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE

NCT07521202 | Not Yet Recruiting DMC

• 1 other identifier: IFG-01-2025
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib. The main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care. Participants will be asked to answer several questionnaires.

Conditions

HR+/HER2- Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to discontinuation

  Time to permanent discontinuation of abemaciclib therapy

  From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first

Secondary Outcomes (4)

• Persistence rate

  At 6 and 12 months after therapy start

• Satisfaction with Information about Medicines Scale (SIMS-D)

  At 6 and 12 months after therapy start

• Medication Adherence Rate Scale (MARS-D)

  At 6 and 12 months after therapy start

• Bloem's patient typology questionnaire

  At 6 and 12 months after therapy start

Study Arms (1)

Standardized patient coaching

EXPERIMENTAL

Patients receive standardized coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)

Behavioral: Standardized patient coaching

Interventions

Standardized patient coaching BEHAVIORAL

Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)

Standardized patient coaching

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 18 or older at time of ICF signature
• Patients with HRpos/HER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago
• Patients treated with abemaciclib according to the SmPC and each center´s medical practice
• Informed consent given prior to the starting study activities

You may not qualify if:

• Women who are pregnant or lactating
• Patients with contraindications against abemaciclib according to the current SmPC
• Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician

Sponsors & Collaborators

• Lilly Deutschland GmbH Germany: collaborator
• Institut fuer Frauengesundheit: lead

Study Sites (1)

Department of Obstetrics and Gynaecology

Erlangen, Bavaria, 91054, Germany

Location

Study Officials

• Peter A. Fasching, Prof. Dr. med.

  Department of Obstetrics and Gynaecology, Uniklinikum Erlangen

  STUDY CHAIR

Central Study Contacts

Sponsor's study office

CONTACT

+49 15739466438; studien@ifg-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

DE (1)