Breast cancer study aims to see what treatments patients actually get
NCT ID NCT07151911
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This observational study follows 100 people with high-risk, hormone receptor-positive, HER2-negative early breast cancer who are already taking a combination of abemaciclib, olaparib, and endocrine therapy. Researchers will track which treatments doctors choose and how patients' quality of life changes over 5 years. The goal is to better understand real-world treatment patterns and patient experiences.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abemaciclib, olaparib, and endocrine therapy
- What this could lead to
- If successful, this study could help doctors better understand which treatments work best for high-risk early breast cancer patients and improve quality of life monitoring.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients, and the small size (100 participants) limits generalizability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
High-risk HR positive, HER2 negative, early breast cancer patients admitted to the Oncology department at the University Hospital of Modena.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliero Universitaria Policlinico di Modena
RECRUITINGModena, Modena, 41124, Italy
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