About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial population
High-risk HR positive, HER2 negative, early breast cancer patients admitted to the Oncology department at the University Hospital of Modena.
Trial design
Cohort
Other
Treatments tested in this trial
abemaciclib, olaparib and endocrine therapy
DrugPatients receiving abemaciclib, olaparib and endocrine therapy.
Treatment groups
Trial outcomes
Primary outcomes
Distribution of treatment options
Type of adjuvant treatment chosen
Sponsors and contacts
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