Clinical trial · Interventional
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer (GATHER): a Study Protocol for a Monocentric, Prospective, Interventional, Phase 2, Imaging Biomarker Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
- description
- Patients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery
- interventionNames
- Other: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
Primary outcomes (1)
- measure
- Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response
- timeFrame
- 2 weeks after surgery
- description
- The concordance rate is defined as the proportion of patients correctly classified by the post-therapeutic PET/CT compared to the gold standard histopathological assessment (ypT0/is ypN0).
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female aged 18 years or older * Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification * Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board * ECOG performance status of 0 or 1 * Affiliated to or beneficiary of a social protection scheme * Written informed consent signed prior to any study-specific procedure Exclusion Criteria: * Pregnant or breastfeeding women * Patient not treated with curative intent * History of ipsilateral breast cancer treated by surgery and/or radiotherapy * Lobular histology * Known contraindication or hypersensitivity to \[68Ga\]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients * Known contraindication or hypersensitivity to \[18F\]F-FDG or any of its radiopharmaceutical excipients * Concurrent enrollment in another clinical trial evaluating radiopharmaceuticals * Patient under guardianship, curatorship, or judicial protection * Patient deprived of liberty * Inability to understand the study or comply with trial constraints due to linguistic, psychological, or geographical barriers
References
Publications (0)
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