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

Breast Cancer

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

Inclusion Criteria21

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
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.