Phase 3 Breast Cancer Trial, Recruiting NCT04722692 Sponsor: Uppsala University Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT04722692
Recruiting Phase 3

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 diagnosed with DCIS (a type of non-invasive breast condition) of any grade or size who are planning to have a full breast removal (mastectomy)
  • People planning a risk-reducing mastectomy where sentinel lymph node surgery would normally be recommended as part of that procedure, either as standard practice at the treating hospital or based on an individual recommendation from their medical team
  • People with a pre-surgery diagnosis of DCIS grade 3 of any size, or DCIS grade 2 measuring 20mm or larger on mammogram, who are planning breast-conserving surgery
  • People with a pre-surgery diagnosis of DCIS detected on a core biopsy, where a lump can be felt during physical examination or is visible on imaging
  • People with a pre-surgery diagnosis of DCIS where there is a suspicion of very early invasion into surrounding tissue, detected on core biopsy
  • People with an imaging finding (mammogram, ultrasound, or MRI) that is suspicious for breast cancer (rated BIRADS 4 or 5) who are planned for a diagnostic surgical removal using breast-conserving surgery, with no confirmed diagnosis of invasive cancer
  • People with a pre-surgery diagnosis of DCIS of any grade or size who are planned for a complex breast reshaping surgical procedure
  • People with a pre-surgery diagnosis of DCIS of any grade or size where the planned surgery may make it harder to perform sentinel lymph node surgery in the future — for example, when the affected area is in the upper outer part of the breast, near the armpit, or when nipple removal is planned (confirm with trial site for other situations)
  • People in any of the above categories whose pre-surgery diagnosis is pleomorphic lobular cancer in situ (pLCIS), classic lobular neoplasia (LN), or atypical ductal hyperplasia (ADH), rather than DCIS

Who may not be able to join:

  • People who have a known intolerance or allergic reaction to iron, dextran compounds, or a substance called SPIO (a type of iron-based imaging agent used in the trial)
  • People who have a medical condition involving an excess of iron in the body (iron overload disease)
  • People who are currently under legal guardianship or whose personal freedom is restricted (confirm with trial site)
  • People who are pregnant or currently breastfeeding

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 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Andreas Karakatsanis, PhD, Uppsala University

Phone: +46765864826

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

Status
Recruiting
Phase
Phase 3
Sponsor
Uppsala University
Registry
ClinicalTrials.gov
Start date
1 March 2020
Est. completion
30 December 2026

Where this trial is recruiting

Hong Kong 🇸🇪 Sweden 🇺🇸 United States

Primary endpoints

d-SLND detection rate; l-SLND detection rate; Nodal concordance

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: 28 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