Breast Cancer Trial, Recruiting NCT05945732 Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT05945732
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:

For both groups:

  • You are 18 years old or older and have been diagnosed with breast cancer that cannot be removed by surgery and/or has spread to other parts of the body, confirmed by a lab test
  • Your doctor has decided to start you on one of two treatments: a drug called T-DXd (trastuzumab deruxtecan) or standard chemotherapy
  • You are willing and able to sign a consent form to take part in the study

For Group 1 only:

  • Your breast cancer has been tested and found to be "HER2-low" (a specific low level of a protein called HER2, confirmed by lab testing)
  • You have already received chemotherapy after your cancer spread, OR your cancer came back during or within 6 months of finishing chemotherapy given after surgery

For Group 2 only:

  • Your breast cancer has been tested and is hormone receptor positive (meaning it is fuelled by hormones like oestrogen or progesterone)
  • Your breast cancer is either "HER2-low" or "HER2-ultralow" (very specific low levels of HER2 protein, confirmed by lab testing)
  • You have already received at least one hormone-based therapy after your cancer spread
  • You have NOT yet received chemotherapy after your cancer spread

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • You are currently taking part in, or have recently taken part in, another clinical trial where neither you nor your doctor knows which treatment you received (a "blinded" study)

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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Registry
ClinicalTrials.gov
Start date
24 October 2023
Est. completion
31 December 2030

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇩🇰 Denmark 🇫🇷 France 🇮🇹 Italy 🇳🇴 Norway 🇵🇹 Portugal 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland

Primary endpoints

Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer

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