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Recruiting NCT06349512

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

No phase Interventional Triple Negative Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-FAPI-46 PET/CT imaging.
Who it may be relevant to
Registry conditions: Triple Negative Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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

Patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. After definitive surgery, patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity.

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.

Interventions

  • Procedure 68Ga-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.

Primary outcome measures

  • Area under the ROC curve [Time frame: 6 months]
Secondary outcome measures (5)
  • Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances [Time frame: Baseline]
  • Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances [Time frame: Baseline]
  • Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances [Time frame: Day 168]
  • Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances [Time frame: 5 years]
  • Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 6 centers
  • Hôpital Privé d'Antony — Antony
  • Institut Curie -site Paris — Paris
  • GH Diaconesses Croix Saint-Simon — Paris
  • Institut Curie -site St Cloud — Saint-Cloud
  • HIA Begin — Saint-Mandé
  • Hôpital FOCH — Suresnes

Identifiers

NCT: NCT06349512 · IC 2022-07 · 2023-507860-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗