Breast Cancer Trial, Recruiting NCT05959291 Sponsor: University of Miami Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT05959291
Recruiting Not Applicable

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 who have been diagnosed with HER-2 positive breast cancer that has spread to other parts of the body (Stage IV).
  • People whose scans (CT, PET, or PET-CT), including a bone scan, show no signs of active cancer — meaning their disease is in complete remission.
  • People who have spread of cancer to the brain may still be considered, as long as that brain disease has been treated and has shown no growth or change on scans for at least 36 months.
  • People who have been on the same HER-2 targeted treatment continuously for at least 36 months.
  • People who have a stored tumour tissue sample available from a previous biopsy.
  • People whose blood test (called the Signatera assay) shows no detectable cancer DNA circulating in the blood.
  • People who are willing to stop their current HER-2 targeted maintenance treatment and be closely monitored.
  • People who are reasonably well and able to carry out daily activities, as measured by a standard medical scoring system (ECOG score of 0 to 2) (confirm with trial site).
  • People aged 18 years or older.
  • People who are able to understand the trial and are willing to sign a consent form.

Who may not be able to join:

  • People whose cancer is not well controlled.
  • People whose cancer has been controlled for less than 36 months on their current HER-2 targeted treatment.
  • People who are currently being treated for, or have been treated for, a second type of cancer in the past 24 months — except for certain minor skin cancers that were surgically removed, or early-stage cancers that had not spread.
  • People whose blood test (Signatera assay) detects cancer DNA in the blood.
  • People who have taken part in another experimental drug trial within the past 28 days, or who plan to do so during this study.
  • People who have a medical condition, ongoing therapy, or abnormal test result that, in the treating doctor's opinion, could interfere with the trial results or make participation unsafe.
  • People who are not able to make their own informed decisions about taking part.

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 14 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.

Contact this trial

Principal Investigator: Elisa Krill Jackson, MD, University of Miami

Phone: 305-689-6500

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
17 July 2023
Est. completion
31 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Feasibility of maintaining remission after discontinuing use of anti-HER-2

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: 14 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