Breast Cancer Trial, Recruiting NCT06830382 Sponsor: Renske Altena Condition: Breast Cancer
Back to Breast Cancer

Breast Cancer Trial, Recruiting

NCT06830382
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:

  • Women aged 18 or older.
  • People with breast cancer that has spread to other parts of the body or has grown into surrounding tissue, and whose cancer has continued to grow after at least one round of chemotherapy given to manage advanced disease — or whose cancer came back within six months of finishing chemotherapy given before or after surgery.
  • People who are willing and able to sign a written consent form to take part in the study.
  • People who have at least one area of cancer spread (metastasis) measuring 10mm or more that can be safely biopsied — or who have had a biopsy of a metastatic area taken within the last 12 months, as long as that area was not treated with HER2-targeted therapy or radiation (confirm with trial site).
  • People who have at least one additional area of cancer spread measuring 10mm or more that can be used to measure how well the treatment is working.
  • People who are reasonably active and able to care for themselves, as measured by a standard health status scale (WHO performance status of 2 or below) (confirm with trial site).
  • People with an expected survival of more than 12 weeks.
  • People who are able to use reliable contraception before, during, and for six months after receiving the study imaging drug — acceptable methods include tubal ligation, male sterilisation, hormonal contraceptives that stop ovulation, or certain intrauterine devices (IUDs). Periodic abstinence and withdrawal are not accepted as sufficient. People who could become pregnant must also agree not to donate eggs during this period, and must have a negative pregnancy test before each dose of the study drug.

Who may not be able to join:

  • People for whom the treatment drug trastuzumab deruxtecan is not suitable or cannot be given according to local medical guidelines.
  • People whose cancer has previously been confirmed as HER2-positive through testing of a metastatic tumour biopsy.
  • People who have another active cancer, apart from a common, non-spreading type of skin cancer called basal cell carcinoma.
  • People with heart, kidney, bone marrow, or liver function that is not adequate for the study (confirm with trial site).
  • People at higher risk of complications from biopsies due to bleeding risks, including those with certain abnormal blood clotting test results, known bleeding disorders such as haemophilia, von Willebrand disease, or platelet disorders, or those taking blood-thinning or anti-clotting medications that cannot be safely paused for the procedure.

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 16 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: Renske Altena, MD PhD, Karolinska Institutet

Phone: +46812377777

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
Sponsor
Renske Altena
Registry
ClinicalTrials.gov
Start date
3 October 2025
Est. completion
1 April 2030

Where this trial is recruiting

🇸🇪 Sweden

Primary endpoints

Therapy-predictive role of HER2-PET for the clinical benefit of treatment with T-DXd in patients with HER2-expressing mBC

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: 16 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