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

Quadrimodal Radiological Prediction (Ultrasound, Angiography/Mammography, Magnetic Rsonance Imaging, Positron Emission Tomography-computed Tomgraphy Scan) of Response to Neoadjuvant Chemoimmunotherapy for Triple-negative Breast Cancer

We will try to see if imaging scans and blood tests can predict which people with triple‑negative breast cancer will have no remaining tumor after pre‑surgery chemo‑immunotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Centre Henri Becquerel (other)
• Drugs / interventions: immunotherapy, pembrolizumab, chemotherapy, cyclophosphamide
• Locations: 1 site (Rouen)
• Trial ID: NCT06879704 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed triple‑negative breast cancer who are scheduled to receive neoadjuvant chemo‑immunotherapy and can attend the Centre Henri Becquerel are ideal candidates.

Not a fit: Patients with metastatic or inflammatory (T4d) disease, contraindications to immunotherapy, or who cannot undergo required imaging (for example due to claustrophobia, ferromagnetic implants, or contrast allergies) are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help doctors predict who will have a complete response before surgery and personalize treatment choices and monitoring to reduce unnecessary therapy or better manage side effects.

How similar studies have performed: Adding pembrolizumab to neoadjuvant chemotherapy (KEYNOTE‑522) increased pathological complete response rates, but using imaging plus blood markers to reliably predict pCR remains an active area of research without definitive validation.

Eligibility criteria

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 this trial is running

Rouen

• Centre Henri Becquerel — Rouen, France (RECRUITING)

Study contacts

• Principal investigator: Florian Clatot, Md, PhD — Centre Henri Becquerel
• Study coordinator: Florian Clatot, MD, PhD

Conditions: Triple Negative Breast Cancer, chemo-immunotherapy, radiological prediction