Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT04896320
Status:
WITHDRAWN
Last Update Posted:
2023-06-22
First Post:
2021-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer.
Sponsor:
Providence Health & Services
Organization:
Study Overview
Official Title:
A Phase 1/2 Study of Tucatinib With Chemotherapy and Trastuzumab in Patients With Previously Treated, Advanced Her-2-Neu Overexpressing Breast Cancer.
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study will be closed due to zero enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2019-101826
Brief Summary:
This is an open label study of tucatinib in combination with either vinorelbine or gemcitabine and trastuzumab in patients with metastatic HER2+ breast cancer.
Detailed Description:
This phase I/II study will assess the recommended dosing of tucatinib in combination with trastuzumab and either vinorelbine or gemcitabine in patients with advanced, HER2+ breast cancer. The study will be conducted as a parallel cohort study looking at optimal dose and safety and efficacy.
Arm 1 Gemcitabine + Tucatinib + Trastuzumab: Gemcitabine (1000 mg/m2) will be administered intravenously on Days 1 and 8. The investigational study drug (tucatinib) will be administered as 300mg by mouth taken twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each cycle.
Arm 2 Vinorelbine + Tucatinib + Trastuzumab: Vinorelbine (25 mg/m2) will be administered intravenously on Days 1 and 8 of each cycle. The investigational study drug (tucatinib) will be administered as 300mg by mouth twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each 2 cycle.
Note: Cycle length is 21 days.
Arm 1 Gemcitabine + Tucatinib + Trastuzumab: Gemcitabine (1000 mg/m2) will be administered intravenously on Days 1 and 8. The investigational study drug (tucatinib) will be administered as 300mg by mouth taken twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each cycle.
Arm 2 Vinorelbine + Tucatinib + Trastuzumab: Vinorelbine (25 mg/m2) will be administered intravenously on Days 1 and 8 of each cycle. The investigational study drug (tucatinib) will be administered as 300mg by mouth twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each 2 cycle.
Note: Cycle length is 21 days.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: