Breast Cancer Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- Adults aged 18 or older.
- People with a good general health and activity level, rated 0 or 1 on a standard medical scale called ECOG (meaning fully active or able to carry out light work).
- People whose breast cancer has been confirmed by a tissue sample (biopsy) and is hormone receptor-positive (meaning the cancer is fuelled by hormones, with ER+ greater than 10%) and HER2-negative (meaning a specific protein is not driving the cancer).
- People who have had surgery to remove early breast cancer, where the lymph nodes were also properly checked (either by sentinel node biopsy or full removal), and whose cancer falls into one of these stages: T1–3, N0, M0 / T1–3, pN1mic, M0 / T1–3, pN1a, M0.
- People for whom the treating Breast Unit has recommended adjuvant hormone therapy or a combination of chemotherapy and hormone therapy after surgery.
- People whose cancer falls into the "intermediate" risk category — not "low" risk (generally defined by at least 5 of: low grade, small tumour, low Ki67, no lymph node involvement, high ER) and not "high" risk (generally defined by at least 4 of: high grade, larger tumour, high Ki67, lymph node involvement, low ER), as set out in an Italian government health decree from May 2021 (confirm with trial site).
- People for whom the Breast Unit has recommended a genomic test, such as Oncotype DX®, Mammaprint®, PAM50 Prosigna®, Breast Cancer Index®, or EndoPredict®.
- People who are able to give written consent to take part in this registry study, as approved by the local Ethics Committee.
- People whose genomic testing was carried out from September 2021 onwards.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose cancer is classified as either "low risk" or "high risk" under the Italian Ministerial Decree of 18 May 2021.
- People whose tumour is hormone receptor-negative (ER negative) and/or HER2-positive.
- People who have more than 3 lymph nodes found to be affected by cancer at staging.
- People whose invasive tumour measures less than 2mm as assessed by the local pathology team.
- People with a previous history of breast cancer.
- People who have two or more separate breast cancers diagnosed at the same time (synchronous cancers).
- People whose cancer appears in multiple locations within the breast (multifocal tumours).
- People whose cancer has spread to other parts of the body (metastatic disease).
- People who have medical reasons that prevent them from receiving standard adjuvant (after-surgery) treatments.
- People whose general health score (ECOG) is greater than 1, or who have other clinical factors making them unsuitable for systemic adjuvant treatment, or who have been recommended only precautionary hormone therapy by the Breast Unit team.
- People with a psychiatric diagnosis that may affect their ability to take part in this study.
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: 0817463762
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer; Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only); Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only); Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only); Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.