Real-world adjuvant treatment for high-risk early breast cancer patients

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

This project will see how adjuvant treatments—including abemaciclib, olaparib, and endocrine therapy—are used and how high-risk HR-positive, HER2-negative early breast cancer patients report their quality of life.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Ospedaliero-Universitaria di Modena (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Modena, Modena)
• Trial ID: NCT07151911 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adults with high-risk hormone receptor–positive, HER2‑negative early breast cancer who are receiving adjuvant abemaciclib, olaparib, or endocrine therapy as part of routine care. Participants complete questionnaires on quality of life and other patient-reported outcomes while investigators record tumor characteristics, genomic risk scores, treatments, and nodal status. Recruitment is planned for about two years and each patient will be followed for five years to capture long-term treatment patterns and patient experience. Collected data will be analyzed descriptively to describe real-world treatment distribution and quality-of-life outcomes.

Who should consider this trial

Good fit: Adults (≥18) with hormone receptor–positive, HER2‑negative early breast cancer classified as high risk by stage, grade, Ki‑67, genomic score, or node status who are receiving abemaciclib, olaparib, or endocrine therapy and can provide informed consent.

Not a fit: Patients with HER2‑positive or metastatic disease, those not on the specified adjuvant therapies, or those unable to complete the study questionnaires are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could clarify real-world use of adjuvant options and help tailor patient support to improve quality of life for high-risk early breast cancer patients.

How similar studies have performed: Large randomized trials have shown benefits for abemaciclib and olaparib in high-risk settings, and prior observational registries have successfully documented real-world treatment patterns and patient-reported outcomes.

Eligibility criteria

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.

Where this trial is running

Modena, Modena

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

Study contacts

• Study coordinator: Luca Moscetti, MD

Conditions: Breast Cancer, Breast cancer, Adjuvant treatment, Safety, Quality of life, Patient reported outcome