Breast Cancer
Conditions
Keywords
early breast cancer, Positron emission tomography, Gallium radioisotopes, pathological complete response
Brief summary
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.
Detailed description
In early-stage HER2-positive breast cancer, neoadjuvant chemotherapy is frequently required, and pathological complete response (pCR) correlates with excellent prognosis. However, no non-invasive imaging method reliably predicts pCR, making surgery mandatory despite its aesthetic, functional, and psychological burden. Recently, new functional imaging tracers targeting the HER2 protein have been developed. Among these, \[68Ga\]Ga-NOTA-anti-HER2-sdAb is of particular interest due to its molecular characteristic; it has demonstrated favorable safety profile and ability to identify HER2+ cells in vivo. This trial evaluates its ability to predict pCR, with the prospect of paving the way for future therapeutic de escalation and surgical sparing.
Interventions
OTHER[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
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response | 2 weeks after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the pCR on both invasive and non-invasive components | two weeks after surgery | The concordance rate is calculated as the proportion of correctly classified patients compared to the non-invasive pCR definition (ypT0 ypN0), in addition to the invasive definition (ypT0/is ypN0) |
| Comparison of the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT against other conventional imaging modalities in predicting the invasive pCR | Two weeks after surgery | ΔSUV is defined as the relative change in SUVmax between the baseline and post-therapeutic \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT, compared according to invasive pathological complete response (ypT0/is ypN0). |
Countries
France
Contacts
CONTACTFlorian Clatot, MD, PhD
CONTACTDoriane Richard, PhD
PRINCIPAL_INVESTIGATORFlorian Clatot, MD, PhD
Centre Henri Becquerel
Outcome results
None listed