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

Last updated: October 16, 2024
Sponsor: Institut Curie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Treatment

68Ga-FAPI-46 PET/CT imaging

Clinical Study ID

NCT06349512
IC 2022-07
2023-507860-37-00
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Female with age ≥ 18 years,

  2. Patients with previously untreated, non-metastatic, centrally confirmed TNBC (stageT1c N1-2 or T2-4 N0-2 per AJCC) 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

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 ofthe investigator, would preclude a valid patient informed consent,

  5. Patients who have difficulty undergoing trial procedures for geographic, social orpsychological reasons,

  6. Patients who are not affiliated to a social security system, or who are deprived ofliberty, or under guardianship.

  7. Person deprived of liberty or under guardianship

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: 68Ga-FAPI-46 PET/CT imaging
Phase:
Study Start date:
October 14, 2024
Estimated Completion Date:
November 30, 2027

Study 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.

Connect with a study center

  • Hôpital Privé d'Antony

    Antony, 92160
    France

    Site Not Available

  • GH Diaconesses Croix Saint-Simon

    Paris, 75020
    France

    Site Not Available

  • Institut Curie -site Paris

    Paris, 75005
    France

    Site Not Available

  • Institut Curie -site St Cloud

    Saint-cloud, 92210
    France

    Active - Recruiting

  • HIA Begin

    Saint-mande, 94160
    France

    Site Not Available

  • Hôpital FOCH

    Suresnes, 92150
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.