Trials / Completed
CompletedNCT04539938
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tucatinib | 300 mg orally twice daily |
| DRUG | trastuzumab deruxtecan | 5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2024-07-15
- Completion
- 2025-03-07
- First posted
- 2020-09-07
- Last updated
- 2026-03-23
- Results posted
- 2025-07-31
Locations
140 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04539938. Inclusion in this directory is not an endorsement.