Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 25, 2023

Primary Completion Date

October 5, 2025

Study Completion Date

October 5, 2028

Conditions
HER2-positive Breast CancerLMD
Interventions
DRUG

Tucatinib 150 MG

Tucatinib is a potent, selective, adenosine triphosphate-competitive small-molecule inhibitor of the receptor tyrosine kinase HER2. The molecular formula for tubatinib is C26H24N8O2 and it has a molecular weight of 480.52 g/mol.

DRUG

Trastuzumab

"MYL-1401O contains the active substance trastuzumab, which is an IgG1 monoclonal antibody. The molecular size of the intact molecule is around 148 kDa.~Each vial of MYL-1401O contains 150 mg of lyophilized proposed active biosimilar substance trastuzumab as well as 3.36 mg L-Histidine Hydrochloride, 2.16 mg L-Histidine, 115.2 mg sorbitol and 33.6 mg PEG-3350 (Macrogol 3350). Sorbitol and PEG-3350 substitute the α- trehalose dehydrate and polysorbate-20, which are used as excipients in the EU-approved and US-licensed Herceptin formulations."

DRUG

Capecitabine

Capecitabine is a tumour-activated antineoplastic agent (antimetabolite). The molecular formula for capecitabine is C15H22FN3O6 and has a molecular weight of 359.35 g/mol.

RADIATION

Brain & Spinal Radiation

Brain \& Spinal XRT is a treatment for patients with HER2+ metastatic breast cancer and leptomeningeal disease,

Trial Locations (2)

Unknown

RECRUITING

The Ottawa Hospital, Ottawa

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Biocon Biologics

UNKNOWN

collaborator

Pfizer

INDUSTRY

lead

Sunnybrook Health Sciences Centre

OTHER

NCT06016387 - Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD | Biotech Hunter | Biotech Hunter