HER2-positive Breast Cancer Clinical Trial
Official title:
A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine
This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive substance. Diagnostic procedures using PET may allow scanners to take pictures of where the drug travels in the body and may help doctors identify which patients may benefit from treatment with ado-trastuzumab emtansine.
PRIMARY OBJECTIVES: I. Correlate uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) PET by individual tumors with subsequent tumor response to ado-trastuzumab emtansine as assessed by serial 18F-fludeoxyglucose (FDG) (fludeoxyglucose F 18)/PET-computed tomography (CT). II. Compare tumor uptake of 64Cu-DOTA-trastuzumab PET between patients who do and patients who do not respond to ado-trastuzumab emtansine. III. Obtain tumor tissue for subsequent assessment of the presence of putative molecular mechanisms of resistance (MMRs) to ado-trastuzumab emtansine. When funding becomes available, those samples will be used to explore the correlation between the presence of MMRs as assessed by histopathology and tumor response to ado-trastuzumab emtansine both in univariate analysis and in combination with tumor uptake of 64Cu-DOTA-trastuzumab as measured with PET/CT. OUTLINE: Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks for 1 year after initiation of treatment until disease progression. After completion of study treatment, patients are followed up for 1 year. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT04578106 -
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
|
Phase 2 | |
| Completed |
NCT01855828 -
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01912963 -
Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
| Recruiting |
NCT04094896 -
TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
| Recruiting |
NCT05346861 -
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
|
Phase 3 | |
| Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
| Completed |
NCT03330561 -
PRS-343 in HER2-Positive Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04997798 -
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT04034823 -
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04756921 -
18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
|
||
| Completed |
NCT03140553 -
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03094052 -
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
|
Phase 2 | |
| Recruiting |
NCT05511844 -
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05325632 -
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
|
Phase 2 | |
| Recruiting |
NCT05710666 -
Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)
|
Phase 2 | |
| Recruiting |
NCT06161922 -
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
|
||
| Not yet recruiting |
NCT05063643 -
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
|