Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer

Sponsor
Centre Henri Becquerel
Study ID
NCT07593976
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography — OTHER
    Patients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery

Study Details

The GATHER trial aim to evaluate the diagnostic performance of \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.

Key Dates

First listed
May 18, 2026
Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Sep 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
    Patients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery

Primary Outcome Measure

Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response [ Time Frame: 2 weeks after surgery ]

Central Contacts

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