Actively Recruiting
Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients
Led by Azienda Ospedaliero-Universitaria di Modena · Updated on 2025-09-03
100
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hormone receptor positive and Her2 negative breast cancer confirmed by local pathology
- Receiving abemaciclib, olaparib, or endocrine therapy as per Italian drug agency rules
- Signed and dated written informed consent
- High-risk early breast cancer with one of the following: anatomical stage IIA N0 with Grade 2 and high risk features (Ki-67 6 20%, Oncotype DX score 6 26, or high genomic risk), Grade 3, anatomical stage IIB, or pathological tumor involvement in 4 ipsilateral axillary lymph nodes
- For patients with 1 to 3 involved lymph nodes (including those with neoadjuvant therapy), must meet at least one of these: Grade 3 tumor, pathological tumor size 6 5 cm, or combined diameter of multifocal/multicentric tumors meeting size criteria
- BRCA mutated patients must be node positive with either 4 or more positive lymph nodes or a CPS&EG score of 3 or higher based on clinical and pathological staging
You will not qualify if you...
- Inability to understand study participation or lack of informed consent
- Not meeting the specified high-risk criteria
- Having other active cancers or diagnosed with other cancers in the past five years except carcinoma in situ of cervix or colon, or basal/squamous cell skin carcinomas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Modena, Italy, 41124
Actively Recruiting
Research Team
L
Luca Moscetti, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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