drugset / Trial / NCT04253561
Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients
NaSingle-groupOpen-labelTreatment
Summary
This is an open label, single arm, multicenter, phase Ib study to evaluate the safety and clinical activity of the combination of ipatasertib, trastuzumab and pertuzumab in patients with unresectable locally advanced or metastatic HER2-positive breast cancer with tumors harboring PIK3CA mutations, candidates to receive maintenance HP after first line treatment for metastatic disease with a taxane plus HP
Timeline
- Start
- 2020-02-25
- Primary completion
- 2021-12-05
- Completion
- 2025-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipatasertib | Small molecule | 200 mg | Oral |
| Subject | Ipatasertib | Small molecule | 300 mg | Oral |
| Subject | Ipatasertib | Small molecule | 400 mg | Oral |
| Background | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 600 mg | Subcutaneous |