RecruitingNCT07151911

Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients


Sponsor

Azienda Ospedaliero-Universitaria di Modena

Enrollment

100 participants

Start Date

Aug 26, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The primary goal of this observational study is to describe the distribution of treatment options and patients' characteristics according to the definition of high-risk status in the early breast cancer (EBC) setting. Participants already taking intervention as part of their regular medical care for EBC will answer questionnaires to also assess quality of life and patient reported outcomes. The recruitment phase will last about 2 years, each patient will be followed up for 5 years.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study in Italy is collecting data on high-risk early breast cancer patients receiving hormone-blocking therapy plus either abemaciclib or olaparib after surgery. The goal is to understand how these treatments work in everyday clinical practice outside of a controlled trial setting. **You may be eligible if...** - You are 18 or older - You have hormone receptor-positive (HR+), HER2-negative early breast cancer that is considered high risk - You are receiving abemaciclib, olaparib, and hormone therapy as prescribed under Italian guidelines - Your cancer meets specific high-risk criteria based on stage, grade, lymph node involvement, or genetic testing results **You may NOT be eligible if...** - You are unable to understand or sign the informed consent - Your cancer does not meet the high-risk criteria specified in the study - You are currently being treated for another active cancer (except certain early-stage skin cancers or cervical in-situ) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGabemaciclib, olaparib and endocrine therapy

Patients receiving abemaciclib, olaparib and endocrine therapy.


Locations(1)

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Modena, Italy

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NCT07151911


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