Status:
RECRUITING
Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 canc...
Detailed Description
The treatment of high-risk hormone receptor (HR) positive, Her2 negative, early breast cancer (EBC) patients has recently changed following the results of practice changing phase III trials. The hormo...
Eligibility Criteria
Inclusion
- Patients will be enrolled in the study if they meet all of the following inclusion criteria:
- Age ≥ 18 years
- Endocrine sensitivity defined as estrogen and or progesterone receptors expression as per local pathological standards
- Her 2 negativity determined as ASCO/CAP guidelines
- Patients receiving abemaciclib, olaparib and endocrine therapy, as per Italian drugs agency rules (AIFA)
- Written informed consent, signed and dated by the patients
- High-risk HR positive, Her2 negative early breast cancer patients with one of the following characteristics:
- Anatomical stage IIA N0 with:
- Grade 2 and evidence of high risk:
- Ki-67 ≥ 20%
- Oncotype DX Breast Recurrence Score ≥ 26 or High risk via genomic risk profiling
- Grade 3
- Anatomical stage IIB.
- Pathological tumour involvement in ≥4 ipsilateral axillary lymph nodes.
- Pathological tumour involvement in 1 to 3 ipsilateral axillary lymph node(s) (for patients who received neoadjuvant therapy also cytological tumour involvement at time of initial diagnosis is allowed) and meet at least 1 of the following criteria:
- Grade 3 as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system (Elston and Ellis 1991),
- Pathological primary invasive tumour size ≥5 cm (for patients who received neoadjuvant therapy primary tumour size ≥5 cm on breast imaging is allowed). Note: if tumour size is needed to meet eligibility criteria, patients with multifocal/multicentric tumours may be eligible based on the addition of diameters of the individual lesions.
- BRCA mutated populations
- Patients must be node positive and fulfil one of the following criteria:
- HR positive, HER2-negative patients must have had ≥4 pathologically confirmed positive lymph nodes
- patients who received prior neoadjuvant chemotherapy: must have had a CPS\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade
Exclusion
- Patients unable to understand the reason for their participation in the study, lack of informed written consent,
- patients who do not meet the high risk criteria as specified in the inclusion criteria,
- patients suffering from other neoplasms for which they receive active treatment, or being diagnosed with other neoplasms (except for: Carcinoma in situ (CIS) of the cervix, CIS of the colon, basal cell and squamous cell carcinomas of the skin) in the five years before adjuvant treatment.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07151911
Start Date
August 26 2024
End Date
September 1 2031
Last Update
September 3 2025
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Modena, Italy, 41124