Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
NCT07593976 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-05-18
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.
Conditions
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 & Collaborators
-
Centre Henri Becquerel
lead OTHER
Principal Investigators
-
Florian Clatot, MD, PhD · Centre Henri Becquerel
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2027-09-01
- Completion
- 2028-03-01
Countries
- France
Study Locations
More Related Trials
-
Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
NCT01937117 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
NCT01805908 ·Status: TERMINATED ·Phase: PHASE1
-
Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3
NCT05376644 ·Status: COMPLETED ·Phase: NA
-
Clinical Value of 89Zr-trastuzumab PET
NCT01832051 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
NCT01363986 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer
NCT01142778 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
NCT06797635 ·Status: RECRUITING ·Phase: PHASE2
-
Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
NCT03979911 ·Status: UNKNOWN
-
89ZrTrastuzumab Breast Imaging With Positron Emission Tomography
NCT02065609 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer
NCT01275859 ·Status: COMPLETED ·Phase: PHASE2
-
HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1
NCT01565200 ·Status: COMPLETED ·Phase: PHASE2
-
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
NCT01420146 ·Status: COMPLETED ·Phase: PHASE1
-
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
NCT00095706 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
NCT04757090 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
NCT07117214 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
NCT07060807 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer
NCT01674062 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
NCT00976989 ·Status: COMPLETED ·Phase: PHASE2
-
GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer
NCT05575804 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.
NCT05203497 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
NCT03433313 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
NCT02131064 ·Status: COMPLETED ·Phase: PHASE3
-
Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
NCT02980341 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
NCT00470704 ·Status: COMPLETED ·Phase: PHASE2
-
Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
NCT03697551 ·Status: TERMINATED ·Phase: PHASE2