drugset / Trial / NCT03144947
Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients
Phase 2
Unknown
65 enrolled
Italian Oncology Group for Clinical Research
Arithmos srl · collabClirest s.r.l. · collabMipharm SpA · collabTemas srl · collabUniversity Hospital of Parma: Department of Biomedical, Biotechnological and Translational Sciences, Pathological Anatomy and Histology Unit · collabUniversity Hospital of Parma:Laboratory of Viral Immunopathology, Unit of Infectious Diseases and Hepatology · collabUniversity Hospital of Parma:Statistica medica ed epidemiologia clinica-UO Ricerca e Innovazione · collab
RandomizedParallel-groupOpen-labelOther
Summary
Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced /Inflammatory HER2-positive Breast Cancer (ImmunHER)
Timeline
- Start
- 2016-11-29
- Primary completion
- 2021-03-15
- Completion
- 2021-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 100 mg/m2 | — |
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 600 mg | Intravenous |