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

Recruiting now

Conditions studied: Breast Cancer

In brief

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 facts

Study ID

NCT07151911

Run by

Azienda Ospedaliero-Universitaria di Modena

People needed

100

Starts

2024-08-26

Expected to finish

2031-09-01

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Azienda Ospedaliero Universitaria Policlinico di Modena — Modena, Modena, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.