drugset / Trial / NCT03054363
Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
Phase 1/2
Completed
42 enrolled
University of Colorado, Denver
Cascadian Therapeutics Inc. · collabCriterium, Inc. · collabPfizer · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or second line of therapy in patients with metastatic hormone receptor positive and HER2-positive breast cancer.
Timeline
- Start
- 2017-11-27
- Primary completion
- 2023-01-17
- Completion
- 2023-02-07
Publications
- Results Shagisultanova E, Crump LS, Borakove M, Hall JK, Rasti AR, Harrison BA, Kabos P, Lyons TR, Borges VF. Triple Targeting of Breast Tumors Driven by Hormonal Receptors and HER2. Mol Cancer Ther. 2022 Jan;21(1):48-57. doi: 10.1158/1535-7163.MCT-21-0098. Epub 2021 Nov 2.
- Shagisultanova E, Gradishar W, Brown-Glaberman U, Chalasani P, Brenner AJ, Stopeck A, Parris H, Gao D, McSpadden T, Mayordomo J, Diamond JR, Kabos P, Borges VF. Safety and Efficacy of Tucatinib, Letrozole, and Palbociclib in Patients with Previously Treated HR+/HER2+ Breast Cancer. Clin Cancer Res. 2023 Dec 15;29(24):5021-5030. doi: 10.1158/1078-0432.CCR-23-0117.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Subject | Palbociclib | Small molecule | 75 mg | Oral |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Subject | Tucatinib | Small molecule | 300 mg | Oral |