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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Modena

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • abemaciclib, olaparib and endocrine therapy

    Drug

    Patients receiving abemaciclib, olaparib and endocrine therapy.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ADJUVANT IN EBC1 intervention

Trial outcomes

Primary outcomes

1

Distribution of treatment options

Type of adjuvant treatment chosen

Time frame
From enrollment to the end of treatment at 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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