Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 29, 2024

Primary Completion Date

February 29, 2028

Study Completion Date

February 28, 2029

Conditions
Brain MetastasesHER2-positive Breast Cancer
Interventions
COMBINATION_PRODUCT

Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine

"SRS and oral tucatinib for 2 wk, followed by oral tucatinib, oral capecitabine, and intravenous (IV) trastuzumab maintenance during 21-d cycles until tumor progression, participant withdrawal, a severe adverse event deemed related to the study drug, or the treating physician discontinues the drug. There are three dosing levels of tucatinib (Dose Level 0, Dose Level -1, or Dose Level -2) using a dose de-escalation scheme. Dosing of capectabine (1000 mg/m2 BID Days 1-14) and trastuzumab (6 mg/kg once per 21 days; 8 mg/kg initial loading dose) per cycle will remain the same regardless of tucatinib dosing.~Dose Level 0: 300 mg twice a day (BID) continuously for 2 wk post SRS, then 300 mg BID continuously per cycle.~Dose Level -1: 250 mg twice a day (BID) continuously for 2 wk post SRS, then 250 mg BID continuously per cycle.~Dose Level -2: 200 mg twice a day (BID) continuously for 2 wk post SRS, then 200 mg BID continuously per cycle."

Trial Locations (1)

33176

RECRUITING

Miami Cancer Institute at Baptist Health, Inc., Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Baptist Health South Florida

OTHER