Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Study ID
- NCT07151911
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- abemaciclib, olaparib and endocrine therapy — DRUGPatients receiving abemaciclib, olaparib and endocrine therapy.
Study Details
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.
Key Dates
- Start date
- Aug 26, 2024
- Status verified
- Aug 2025
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2031
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: ADJUVANT IN EBCHigh-risk HR positive, Her2 negative early breast cancer patients receiving abemaciclib, olaparib and endocrine therapy.
Primary Outcome Measure
Distribution of treatment options [ Time Frame: From enrollment to the end of treatment at 5 years ]
Central Contacts
- Luca Moscetti, MD+ 39.059.422.3244
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