Using imaging and blood tests to predict response to pre-surgery chemo‑immunotherapy in triple‑negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants scheduled to receive standard neoadjuvant chemo‑immunotherapy (including pembrolizumab with sequential chemotherapy as per current practice) will undergo a series of imaging exams and blood sampling before and during treatment. Multiple imaging techniques (for example mammography and contrast‑enhanced MRI or other contrast imaging) will be compared alone and in combination to identify patterns that correlate with pathological complete response (RCB 0) at surgery. Blood biomarkers will also be tested to identify signatures linked to benefit from treatment and to predict immune‑related toxicities, enabling more personalized monitoring. Imaging and biomarker results will be correlated with surgical pathology and clinical outcomes to build predictive models.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent
* Patient with histologically proven TNBC
* Indication for neo-adjuvant chemo-immunotherapy treatment
* Age between 18 and 75
* Affiliated or beneficiary of a social protection scheme

Exclusion Criteria:

* Pregnant or breast-feeding women
* Contraindication to immunotherapy
* Inflammatory breast cancer (T4d)
* Metastatic patients
* Allergies to iodine or gadolinium
* Patient with an augmentation prosthesis (for angiography/mammography)
* Claustrophobic patients
* Renal contraindication to contrast products according to SFR-CIRTACI
* Ferromagnetic material
* Uncontrolled diabetes (blood glucose \>10 mmol/L)
* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
* Patient under guardianship, curatorship or safeguard of justice

Where it's running

• Centre Henri Becquerel
  Rouen, France Recruiting

Study contacts

• Principal investigator: Florian Clatot, Md, PhD — Centre Henri Becquerel
• Study coordinator: Florian Clatot, MD, PhD
• Email: florian.clatot@chb.unicancer.fr
• Phone: +33276673004

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.