A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain
NCT05892068 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-02-13
Summary
The purpose of this study to see how the brain absorbs, distributes, and gets rid of tucatinib in people who have HER2+ cancers (breast cancer, NSCLC, CRC, or GEC) that have spread to the brain, and to learn more about how cancer cells develop resistance to treatment. The researchers will do research tests to look for genetic differences between HER2+ breast cancer that has spread to the brain and progressed during treatment with tucatinib and cancers that are being treated with tucatinib for the first time.
Conditions
Interventions
- DRUG
-
Standard dose of 300mg orally twice daily for 4 days prior to surgery (day -4 to 0).
Sponsors & Collaborators
- collaborator INDUSTRY
-
Seagen Inc.
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Andrew Seidman, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-09
- Primary Completion
- 2028-05-09
- Completion
- 2028-05-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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