Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04220203|
Expanded Access Status : Approved for marketing
First Posted : January 7, 2020
Last Update Posted : May 7, 2020
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 (firstname.lastname@example.org).
|Condition or disease||Intervention/treatment|
|HER2-positive Breast Cancer||Drug: Tucatinib Drug: Capecitabine Drug: Trastuzumab|
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||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|
- 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