RecruitingPhase 2NCT06016387

Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

30 participants

Start Date

Nov 25, 2023

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer LMD

Summary

The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether adding brain and/or spinal radiation to a triple drug regimen (tucatinib, trastuzumab, and capecitabine) can help people with HER2-positive breast cancer that has spread to the fluid and lining around the brain (called leptomeningeal disease). **You may be eligible if...** - You have HER2-positive (or HER2-mutated/amplified) metastatic breast cancer - Your cancer has spread to the lining of the brain or spinal cord - You are 18 or older with a reasonable level of functioning (ECOG 0–2) - Your blood counts and organ function are within required ranges **You may NOT be eligible if...** - You have previously received tucatinib or prior whole-brain radiation for brain metastases - You have previously received treatment specifically targeting leptomeningeal disease - You cannot swallow pills or have severe gut absorption issues - You are pregnant or breastfeeding - You have a heart attack or unstable angina within the past 6 months - You are allergic to tucatinib, trastuzumab, or capecitabine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTucatinib 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.

DRUGTrastuzumab

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.

DRUGCapecitabine

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.

RADIATIONBrain & Spinal Radiation

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