Phase 4 Breast Cancer Trial, Recruiting NCT07195344 Sponsor: Institut Claudius Regaud Condition: Breast Cancer
Back to Breast Cancer

Phase 4 Breast Cancer Trial, Recruiting

NCT07195344
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 a man or woman aged 18 or older with breast cancer that has been confirmed by a tissue sample (biopsy).
  • Your breast cancer has spread to other parts of the body or is locally advanced, and your cancer has been tested and found to have a certain level of a protein called HER2 (ranging from very low to high amounts).
  • You are considered suitable by your doctor to receive a specific cancer treatment called Trastuzumab-Deruxtecan (T-DXd).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 3 days before starting the study treatment.
  • If you are a woman who could become pregnant, you must agree to use at least one reliable method of contraception (or be surgically sterile, or abstain from sexual activity) throughout the study and for 7 months after your last dose.
  • If you are a man, you must agree to use at least one reliable method of contraception throughout the study and for 4 months after your last dose.
  • You are willing and able to follow the study rules and have signed a consent form agreeing to take part.
  • You are covered by the French national health insurance system.

Who may not be able to join:

  • You have poor vein access that makes taking blood samples difficult.
  • For any reason, you are unable to receive T-DXd at the required starting dose.
  • You have another cancer that is currently getting worse or needs active treatment (some skin cancers or early-stage cervical cancer that have been treated may be exceptions — confirm with trial site).
  • You have another significant medical, mental health, or surgical condition that is not currently under control and could affect your ability to take part in the study.
  • You are currently pregnant or breastfeeding.
  • Your personal, family, geographical, or social situation might make it difficult for you to give proper consent or follow the study procedures, as judged by the study doctor.
  • You are under a legal protection order or have had your freedom restricted by a legal or administrative decision.
  • You are currently taking part in another clinical trial involving an experimental drug.
  • You have a known allergy or serious reaction to T-DXd or any of its ingredients.
  • You have severe liver problems, based on specific blood test results being significantly above normal levels (confirm with trial site).

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

Contact this trial

Phone: +33531155104

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 4
Sponsor
Institut Claudius Regaud
Registry
ClinicalTrials.gov
Start date
15 October 2025
Est. completion
1 October 2029

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Primary Outcome Measure

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: 23 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