Table of Contents
- Trial overview
- Breast cancer studies
- Colorectal cancer studies
- Special patient groups
- Phases and endpoints
- What the trials measure
Trial overview
The trial list shows that Tucatinib is being studied in several cancer settings, mostly HER2-positive breast cancer and HER2-positive colorectal cancer.[1][2] Most studies are interventional, which means patients are assigned to a treatment plan and researchers measure the results.[1]
The studies include people with advanced, metastatic, unresectable, or previously treated disease, and some trials include patients with brain or leptomeningeal spread.[3][5][8]
Breast cancer studies
Several trials study Tucatinib in HER2-positive breast cancer, including advanced, metastatic, and locally advanced disease.[2][4][7][4] Some studies compare Tucatinib-based treatment with placebo or standard care, while others test new drug combinations.
NCT03975647 is a Phase 3 study in unresectable locally advanced or metastatic HER2+ breast cancer. It compares Tucatinib with placebo when used with ado-trastuzumab emtansine, and the main outcome is progression-free survival by investigator review.[2]
NCT05132582 is another Phase 3 breast cancer study. It compares Tucatinib versus placebo when combined with pertuzumab and trastuzumab, and it measures progression-free survival.[7]
NCT05041842 is a Phase 2 study for HER2+ metastatic breast cancer with isolated brain progression. It looks at whether Tucatinib with pertuzumab and trastuzumab can improve the 6-month progression-free survival rate.[3]
2024-519624-24-00 is a Phase 2 study in HER3-mutant and HER2-not amplified metastatic breast cancer. It tests Tucatinib with trastuzumab and measures clinical benefit rate, meaning the share of patients with tumor response or stable disease for at least 24 weeks.[4]
NCT06162559 is a Phase 1 neoadjuvant study, meaning treatment is given before surgery. It tests a chemotherapy-free plan with trastuzumab, pertuzumab, and Tucatinib in stage II-III HER2-positive breast cancer, and the main safety endpoint is adverse events.[6]
NCT05583110 is a completed Phase 1 study in non-resectable locally advanced or metastatic HER2-positive breast cancer. It studied Tucatinib with trastuzumab and vinorelbine, and the main endpoint was objective response rate.[8]
2025-524498-17-00 is a Phase 4 study in pretreated HER2-positive locally advanced or metastatic breast cancer, with or without CNS metastases. It compares a new treatment combination against Tucatinib with trastuzumab and capecitabine, and the main outcome is progression-free survival.[4]
2025-524613-89-00 is a Phase 1/2-style development study focused on safety and early benefit in HER2-positive advanced breast cancer. It studies zanidatamab with Tucatinib and chemotherapy, and the early phase part looks at maximum tolerated dose and recommended phase 2 dose.[4]
2022-502351-60-00 is a Phase 2 study for HER2-amplified metastatic breast cancer with leptomeningeal metastases. It tests Tucatinib and capecitabine with intra-CSF trastuzumab, and the key result is 12-month overall survival rate.[4]
2022-500743-20-00 is a Phase 2 trial in metastatic HER2+ breast cancer. It evaluates Tucatinib with oral etoposide and trastuzumab, with objective response rate in the first 6 months as the main endpoint.[4]
Colorectal cancer studies
The trial list also includes HER2-positive colorectal cancer studies.[1][4] These studies ask whether Tucatinib can improve control of cancer when added to other treatments.
NCT05253651 is a Phase 3 study in unresectable or metastatic HER2+ colorectal cancer. It compares Tucatinib with trastuzumab and mFOLFOX6 against standard care, and the main endpoint is progression-free survival by blinded independent central review.[1]
2024-515152-20-00 is a Phase 2 colon cancer study that includes a target-driven group with HER2+/RAS wild-type disease. One part of the study measures ct-DNA clearance after adjuvant treatment with FOLFOX plus trastuzumab and Tucatinib, which means researchers check whether cancer DNA in blood becomes undetectable.[4]
Special patient groups
Some trials focus on groups with difficult-to-treat disease sites or unusual tumor changes.[3][4][4]
Patients with brain metastases are included in NCT05041842 and 2025-524498-17-00, showing interest in whether Tucatinib-based treatment can help when cancer has spread to the brain.[3][4]
Patients with leptomeningeal metastases, meaning spread to the lining and fluid around the brain and spinal cord, are included in 2022-502351-60-00.[4]
The 2024-519624-24-00 study includes HER3-mutant disease, which means the tumor has a change in the HER3 gene, even when HER2 is not amplified.[4]
Trial NCT04579380 includes previously treated HER2-altered solid tumors, so it is broader than breast or colorectal cancer alone.[5]
Phases and endpoints
The trials cover Phase 1, Phase 2, Phase 3, and Phase 4 research.[1][6][4] Phase 1 studies mainly look at safety, dose finding, and whether the treatment can be given as planned.[6][4]
Later phases focus more on whether the treatment works better than another option or placebo.[1][2][7] Phase 4 research in the list is designed to compare effectiveness and safety after earlier development work.[4]
What the trials measure
The most common endpoint is progression-free survival, which means the time before the cancer gets worse or the patient dies from any cause.[1][2][7]
Other important endpoints include objective response rate, clinical benefit rate, overall survival, dose-limiting toxicities, and adverse events.[3][4][5][6]
One colon cancer study uses ct-DNA clearance, which is a blood-based measure of whether cancer-related DNA can still be detected after treatment.[4] Several trials also use RECIST v1.1, a standard scan-based method for measuring tumor change.[1][2]
