Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03054363
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2017-02-07
Brief Title:
Tucatinib Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Phase IBII Open-label Single Arm Study to Evaluate Safety and Efficacy of Tucatinib in Combination With Palbociclib and Letrozole in Subjects With Hormone Receptor Positive and HER2-positive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CDK46 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
Detailed Description:
This is a multicenter single arm open-label run-in phase Ib roll-over phase II study of novel HER2-targeted tyrosine kinase inhibitor tucatinib in combination with CDK46 inhibitor palbociclib and aromatase inhibitor letrozole in subjects with HRHER2 locally advanced unresectable or metastatic breast cancer The study will enroll post-menopausal women and premenopausal women if on treatment with or willing to be treated with standard ovarian suppression The phase Ib part of the study will determine safety and tolerability of the combination of tucatinib palbociclib and letrozole to confirm that current RP2D of tucatinib and FDA approved dosing of palbociclib remains the same in the triplet combination The dose of letrozole will be constant through the study period Once the safety of the combination is established we will move to the phase II part of the study in the expansion cohort of subjects at RP2D for the purpose of assessing efficacy while further refining assessment of safety of the combination treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2017-01776 | OTHER | CTRP | None |