Ireland
--:--IST
Latest
Clinical Trials in Italy / NCT07151911
Recruiting Observational

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

NCT07151911 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-08-26
Last updated
2025-09-03

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

abemaciclib, olaparib and endocrine therapy

abemaciclib, olaparib and endocrine therapy: Patients receiving abemaciclib, olaparib and endocrine therapy.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Azienda Ospedaliero Universitaria Policlinico di Modena Modena Modena Recruiting

More Azienda Ospedaliero-Universitaria di Modena trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07151911 on ClinicalTrials.gov ↗ ← All trials in Italy