drugset / Trial / NCT04494958
Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer
Phase 1/2
Completed
24 enrolled
Fundacion Oncosur
Apices Soluciones S.L. · collabPfizer · collabPierre Fabre Ibérica, S.A. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is an interventional, prospective, multicentric, single-arm, open label, phase Ib clinical trial. This study will be carried out in patients diagnosed of metastatic or locally advanced unresectable triple negative breast cancer with activation of ERK and/or CDK4/6 in which the following will be assesed: the overall response rate, the aggregation of antitumor effect depending on the different kinome profiles and the safety profile to the combination of palbociclib and binimetinib.
Timeline
- Start
- 2020-11-18
- Primary completion
- 2023-12-14
- Completion
- 2023-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Binimetinib | Small molecule | 45 mg | Oral |
| Subject | Palbociclib | Small molecule | 100 mg | Oral |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |