Patient Relevant Outcomes Improvement Program in High Ris... | NCT07531693

Studies
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer

NCT07531693

Sponsor

Institut fuer Frauengesundheit

Status

Recruiting

Last Update Posted

May 14, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

HR+/HER2- Early Breast Cancer

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2026Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Mar 2027Estimated

First Submitted Date

Apr 9, 2026

First Submission Date that Met QC Criteria

Apr 9, 2026

First Posted Date

Apr 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

Name	Class
Lilly Deutschland GmbH Germany	UNKNOWN
AGO-B Breast Study Group	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start. To this end, researchers will perform a retrospective analysis of therapy data.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-risk HR+/HER2- early breast cancer patients		High-risk HR+/HER2- early breast cancer patients under abemaciclib therapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abemaciclib persistence rate	Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)	6 months after therapy start

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Femal patients age 18 or older at time of informed consent
Confirmed diagnosis of HR+/HER2- early breast cancer (no distant metastasis)
Prescribed abemaciclib therapy according to the Summary of Product Characteristics (SmPC)
Abemaciclib therapy occured between January 1st, 2023 and June 30th, 2025

Exclusion Criteria:

Locally advanced or metastatic breast cancer
Male patients
Patients with contraindication(s) for abemaciclib therapy according to SmPC

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients will be selected from up to 30 study sites across Germay. Sites will be selected from certified breast cancer centers that have experience providing adjuvant treatment to breast cancer patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sponsor's study office	Contact	+49 15739466438		studien@ifg-erlangen.de

Overall Officials

Name	Affiliation	Role
Peter A. Fasching, Prof. Dr. med.	Department of Obstetrics and Gynaecology, Uniklinikum Erlangen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynaecology, Uniklinikum Erlangen	Recruiting	Erlangen	Bavaria	91054	Germany