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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female with age ≥ 18 years,

• 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,

• Patients with measurable targets according to RECIST/PERCIST criteria,

• Patients without distant metastasis based on staging 18F-FDG PET/CT,

• Patients with tumor tissue available,

• Patients who provided a signed written informed consent,

• Patient ability to comply with protocol requirements,

• Patients covered by a health insurance system.

Locations
Other Locations
France
Hôpital Privé d'Antony
RECRUITING
Antony
GH Diaconesses Croix Saint-Simon
RECRUITING
Paris
Institut Curie -site Paris
RECRUITING
Paris
Institut Curie -site St Cloud
RECRUITING
Saint-cloud
HIA Begin
RECRUITING
Saint-mandé
Hôpital FOCH
RECRUITING
Suresnes
Contact Information
Primary
Sandra Nespoulous
drci.promotion@curie.fr
0147111654
Backup
Marie-Emmanuelle LEGRIER
drci.promotion@curie.fr
0156245649
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2032-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Triple Negative Breast Cancer
Patients with early-stage high-risk Triple Negative Breast Cancer
Related Therapeutic Areas
Sponsors
Leads: Institut Curie

This content was sourced from clinicaltrials.gov

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