Study on Trastuzumab Deruxtecan (T-DXd) for Treating Brain Cancer

Inclusion Criteria

• Adults aged 18 or older with one or more brain tumors scheduled for surgery or biopsy.
• Diagnosed with glioblastoma or metastatic cancer with a history of HER2 expression or mutation.
• HER2 positive or low as defined by specific medical guidelines.
• Other untreated brain tumors and previous radiation treatments are allowed.
• Patients with brain and spinal fluid cancer spread are eligible if they have brain tumors needing surgery or biopsy.
• Different groups include those with brain metastases from HER2-expressing cancer, with or without prior T-DXd treatment, and those with recurrent glioblastoma.
• No limit on previous brain radiation or systemic therapy, including HER2-targeting treatments.
• Good overall health with a performance status score of 60 or higher.
• Life expectancy of more than 12 weeks.
• Heart function with an ejection fraction of 50% or higher.
• Adequate blood, kidney, liver, and clotting function based on specific lab tests.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.
• Men must use condoms and avoid fathering a child during and after the study.
• Willingness to comply with study requirements and provide informed consent.

Exclusion Criteria

• Allergic reaction to T-DXd or its components.
• Significant health issues as determined by the study doctor.
• Inability to follow study procedures or attend follow-up visits.
• Metal implants or other conditions preventing MRI scans.
• Recent heart attack or severe heart failure.
• Abnormal heart rhythm on an ECG.
• High troponin levels without heart symptoms require a heart specialist's evaluation.
• History of lung disease requiring steroids or current lung issues.
• Serious lung conditions or autoimmune diseases affecting the lungs.
• Uncontrolled infections needing IV treatment.
• Active immune system disorders or infections like HIV or hepatitis.
• Recent live vaccine within 30 days before starting T-DXd.
• Unresolved side effects from previous cancer treatments.
• Known allergy to study drugs or their components.
• Pregnant or breastfeeding women, or those planning to become pregnant.
• Substance abuse or other medical conditions that may interfere with the study.
• Multiple cancers within the last 3 years, except for certain non-threatening types.
• Fluid buildup around the lungs, heart, or abdomen needing drainage.