Using PET/CT imaging to predict treatment response 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

This prospective multicenter study evaluates how well 68Ga-FAPI-46 PET/CT imaging can predict histological response in patients with early-stage high-risk triple-negative breast cancer (TNBC) undergoing neoadjuvant treatment with pembrolizumab and chemotherapy. Patients will receive standard neoadjuvant therapy, including pembrolizumab and a combination of chemotherapy agents, followed by surgery and adjuvant pembrolizumab. The study aims to perform PET/CT scans before treatment to assess their effectiveness in predicting patient outcomes. The results could help tailor treatment plans based on individual responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female with age ≥ 18 years,
2. Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
3. Patients with measurable targets according to RECIST/PERCIST criteria,
4. Patients without distant metastasis based on staging 18F-FDG PET/CT,
5. Patients with tumor tissue available,
6. Patients who provided a signed written informed consent,
7. Patient ability to comply with protocol requirements,
8. Patients covered by a health insurance system.

Exclusion Criteria:

1. Pregnant and lactating women,
2. Patients with prior anti-PD(L)1 immunotherapy,
3. Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
4. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
5. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
6. Person deprived of liberty or under guardianship

Where it's running

• Hôpital Privé d'Antony
  Antony, France Recruiting
• Institut Curie -site Paris
  Paris, France Recruiting
• GH Diaconesses Croix Saint-Simon
  Paris, France Recruiting
• Institut Curie -site St Cloud
  Saint-Cloud, France Recruiting
• HIA Begin
  Saint-Mandé, France Recruiting
• Hôpital FOCH
  Suresnes, France Recruiting

Study contacts

• Principal investigator: Romain-David SEBAN — Institut Curie
• Study coordinator: Sandra Nespoulous
• Email: drci.promotion@curie.fr
• Phone: 0147111654

Similar studies

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

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• Granzyme B-PET to see if immunotherapy works in TNBC

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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.