Hadden Heights, New Jersey
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Phase
3Span
229 weeksSponsor
Greenwich LifeSciences, Inc.Eggenfelden
Recruiting
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
Eligible participants will be those patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd treatment or patients with documented HER2-low unresectable or metastatic BC receiving T DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice. All diagnostic and treatment procedures including visit frequency are at the discretion of the treating physician and not defined by the protocol. T-DXd treatment is considered as a selection criteria. Patients will be informed about use of digital healthcare application (DiGA). Approximately 800 eligible participants will be enrolled which includes 400 patients in the HER2-positive cohort and 400 patients in the HER2-low cohort.
Phase
N/ASpan
434 weeksSponsor
AstraZenecaEggenfelden
Recruiting
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.
Phase
3Span
687 weeksSponsor
AstraZenecaEggenfelden
Recruiting
Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
Phase
N/ASpan
616 weeksSponsor
AstraZenecaEggenfelden
Recruiting
Eggenfelden
Recruiting