Breast Cancer Trial, Not Yet Recruiting NCT06807749 Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Condition: Breast Cancer
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Breast Cancer Trial, Not Yet Recruiting

NCT06807749
Not Yet Recruiting Not Applicable

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

  • Women who are premenopausal and aged 18 or older.
  • People who agree to take part in the study and sign the required consent form.
  • People with a confirmed tissue diagnosis of early breast cancer that is hormone receptor positive (responding to estrogen and/or progesterone) and HER2-negative.
  • People whose cancer has been staged as having no affected lymph nodes or 1 to 3 affected lymph nodes, and a primary tumour within a certain size range (confirm with trial site for exact staging details).
  • People who have had surgery for their primary breast cancer, including a procedure to check the lymph nodes under the arm.
  • People who have results available from a specific 21-gene tumour test called Oncotype DX, performed between 1 January 2013 and 31 December 2022.
  • People whose medical and pathological records are available for review.
  • People whose records include details about any additional treatments received after surgery.
  • People whose records include information about how their cancer progressed over time, including any return of cancer and survival outcomes.

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 has spread to distant parts of the body.
  • People diagnosed with inflammatory breast cancer.
  • People who received treatment (such as chemotherapy or other therapy) before surgery.
  • People who did not have surgery for their primary breast cancer or lymph node assessment.
  • People who have not had the Oncotype DX 21-gene tumour test performed.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 April 2025
Est. completion
1 September 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Invasive Disease-Free Survival (iDFS) at 5 years

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov