Phase 4 Breast Cancer Trial, Recruiting NCT06274515 Sponsor: Hoffmann-La Roche Condition: Breast Cancer
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Phase 4 Breast Cancer Trial, Recruiting

NCT06274515
Recruiting Phase 4

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:

  • You are willing to have a biopsy (a small tissue sample taken from a tumor) and a blood draw
  • You have been diagnosed with either HER2-positive, hormone receptor-positive breast cancer (cohort R1) or triple-negative breast cancer (cohort T1), based on your local doctor's assessment
  • A stored sample of your tumor tissue from a previous biopsy or procedure is available
  • You have a tumor that is clearly growing and can be reached for a biopsy or surgical removal
  • You stopped your previous cancer treatment no more than 4 weeks before joining the study
  • (For acquired resistance cohorts) Your cancer was being monitored regularly while on your most recent treatment, and a tumor lesion either appeared for the first time or started growing again after you had been on that treatment for at least 6 months
  • (For primary resistance cohort) A tumor lesion kept growing or a new one appeared while you were on treatment for at least 4 weeks but less than 6 months

Who may not be able to join:

  • You have a condition that raises the risk of complications from a biopsy, such as a bleeding disorder
  • You have a serious health condition or abnormal lab test results that could make it unsafe for you to participate
  • You have already started a new cancer treatment
  • The tumor being targeted for biopsy or removal is located in the bone
  • You stopped your previous cancer treatment for a reason other than your cancer getting worse

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 30 June 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
2 April 2024
Est. completion
30 September 2026

Where this trial is recruiting

🇧🇪 Belgium 🇩🇰 Denmark 🇫🇮 Finland 🇩🇪 Germany 🇮🇹 Italy 🇳🇴 Norway 🇪🇸 Spain 🇬🇧 United Kingdom

Primary endpoints

Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2); Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2); Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2); Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3); Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (C...

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: 30 June 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