Trials / Approved For Marketing
Approved For MarketingNCT04220203
Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle. To learn more about this program, contact Seattle Genetics' Medical Information (medinfo@seagen.com).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tucatinib | 300 mg orally two times per day |
| DRUG | Capecitabine | 1000 mg/m\^2 orally two times per day on Days 1-14 of each 21-day cycle |
| DRUG | Trastuzumab | Loading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle |
Timeline
- First posted
- 2020-01-07
- Last updated
- 2025-06-26
Source: ClinicalTrials.gov record NCT04220203. Inclusion in this directory is not an endorsement.