Breast Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 years or older
- People whose breast cancer tests positive for hormone receptors (estrogen and/or progesterone), as assessed by local laboratory standards
- People whose breast cancer tests negative for HER2, as assessed using standard guidelines (ASCO/CAP)
- People who are receiving a combination of three treatments — abemaciclib, olaparib, and hormone therapy — as approved under Italian medicines agency (AIFA) rules
- People who have provided written informed consent, signed and dated
- People with high-risk, hormone receptor-positive, HER2-negative early breast cancer who meet one of the following characteristics:
- Cancer at anatomical stage IIA with no lymph node involvement, combined with either: a Grade 2 tumour that also has a high Ki-67 score (20% or above) or a high genomic risk score (Oncotype DX score of 26 or above, or high risk on other genomic testing); or a Grade 3 tumour
- Cancer at anatomical stage IIB
- Cancer that has spread to 4 or more lymph nodes under the arm on the same side as the tumour
- Cancer that has spread to 1 to 3 lymph nodes under the arm on the same side, and also meets at least one of these additional conditions: the tumour is graded as Grade 3 using a recognised scoring system; or the tumour measured 5 cm or larger (this may be based on imaging for people who received chemotherapy before surgery)
- For people with a BRCA gene mutation: lymph node involvement is required, plus one of the following — cancer that spread to 4 or more confirmed positive lymph nodes; or, for people who received chemotherapy before surgery, a combined score (CPS&EG score) of 3 or higher based on pre- and post-treatment assessments (confirm with trial site)
Who may not be able to join:
- People who are unable to understand the reason for taking part in the study, or who have not provided written informed consent
- People whose cancer does not meet the high-risk criteria described above
- People who have another active cancer currently being treated, or who were diagnosed with another cancer in the five years before starting adjuvant treatment — exceptions include: cervical carcinoma in situ, carcinoma in situ of the colon, and basal cell or squamous cell skin cancers
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: + 39.059.422.3244
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Distribution of treatment options
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Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.