Using PET/CT imaging to predict treatment response in triple-negative breast cancer

68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer

This study is testing if a special type of imaging can help predict how well early-stage triple-negative breast cancer patients will respond to their treatment with pembrolizumab and chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut Curie (Academic / other)
• Drugs / interventions: pembrolizumab, chemotherapy, immunotherapy, cyclophosphamide, doxorubicin
• Locations: 6 sites (Antony and 5 other locations)
• Trial ID: NCT06349512 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 and older with untreated, non-metastatic, centrally confirmed triple-negative breast cancer who are eligible for neoadjuvant chemotherapy with pembrolizumab.

Not a fit: Patients who are pregnant, have prior anti-PD(L)1 immunotherapy, or have contraindications to the standard treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized treatment strategies for patients with triple-negative breast cancer, potentially improving outcomes.

How similar studies have performed: While similar imaging approaches have been explored, this specific use of 68Ga-FAPI-46 PET/CT for predicting treatment response in TNBC is relatively novel.

Eligibility criteria

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 this trial is running

Antony and 5 other locations

• 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

Conditions Triple Negative Breast Cancer