HER2-positive Breast Cancer Clinical Trial
Official title:
HER2-directed Biosimilar OgivriTM in Breast Cancer: Real World Observational Trial for the Description of Quality of Life and Outcome Using ePRO (OGIPRO- Trial)
This project will engage anti-HER2 directed Trastuzumab biosimilar with a novel quality of ePRO and enable comparison of reliable reference real world patient data, thereby creating a basis for analytic research in order to promote the quality and efficiency of treatment
Comprehensive data on patient history and follow-up modalities, AEs and outcome will be collected as ePRO to provide high-quality reports and quantitatively abundant data provided by patients. In particular, prospectively collected data shall be compared to previously collected ePRO from women treated for HER2-positive BC in a variety of indications and settings . Since a large number of data entries for wellbeing and symptom reporting (according to CTCAE) is available from these patients, the investigators will refer to this as a historic registry data warehouse. Accordingly, the ePRO from these patients treated for HER2 positive BC are available for planned comparative analysis and shall be applied to indicate differences in anti-HER2 directed medication between Ogivri and Herceptin. ;
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 | |
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 | |
Completed |
NCT01855828 -
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for 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
|