RecruitingNot ApplicableNCT06349512

68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)

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


Sponsor

Institut Curie

Enrollment

60 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of PET scan (called 68Ga-FAPI-46) to see whether it can predict how well triple-negative breast cancer (an aggressive subtype of breast cancer) will respond to chemotherapy plus immunotherapy given before surgery. **You may be eligible if...** - You are a female aged 18 or older - You have been newly diagnosed with triple-negative breast cancer (TNBC) that has not been treated yet and has not spread to distant organs - Your doctor recommends pre-surgery treatment with chemotherapy plus pembrolizumab (an immunotherapy) - You have a measurable tumor on imaging - You are covered by health insurance **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have previously received immunotherapy (anti-PD-1 or anti-PD-L1) - You have a condition that prevents you from receiving the standard treatment combination - You have already had distant metastases identified on staging scans Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURE68Ga-FAPI-46 PET/CT imaging

The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.


Locations(6)

Hôpital Privé d'Antony

Antony, France

Institut Curie -site Paris

Paris, France

GH Diaconesses Croix Saint-Simon

Paris, France

Institut Curie -site St Cloud

Saint-Cloud, France

HIA Begin

Saint-Mandé, France

Hôpital FOCH

Suresnes, France

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NCT06349512


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