Actively Recruiting
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
Led by Sunnybrook Health Sciences Centre · Updated on 2026-02-23
30
Participants Needed
2
Research Sites
253 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
B
Biocon Biologics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women with HER2-positive, HER2-mutated, or HER2-amplified metastatic breast cancer as defined by ASCO-CAP 2018 guidelines or clinically validated blood/CSF tests
- Evidence of leptomeningeal disease in the brain and/or spine by cerebrospinal fluid cytology or MRI
- Age 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- At least 14 days or 5 half-lives since last dose of any experimental agent, whichever is greater
- All prior cancer therapy toxicities resolved to Grade 1 or less, except alopecia; neuropathy resolved to Grade 2 or less
- Left ventricular ejection fraction within normal institutional limits documented within 2 weeks before starting systemic therapy
- Adequate blood counts and organ function within 2 weeks before phase 2 enrollment
- Last dose of prior therapy completed at least 14 days before study enrollment
- Prior chemotherapy, immunotherapy, endocrine therapy, targeted therapy, and experimental agents allowed, including prior trastuzumab and capecitabine use
You will not qualify if you...
- Prior whole brain radiotherapy for brain metastases (stereotactic radiosurgery within 7 days before consent allowed)
- Prior therapy specifically targeting leptomeningeal disease, including prior radiotherapy or systemic therapy
- Inability to comply with MRI surveillance of central nervous system disease
- Inability to swallow pills or uncontrolled gastrointestinal diseases such as inflammatory bowel disease causing diarrhea
- Diagnosed with hereditary fructose intolerance
- Diagnosed with Gilbert's disease
- Prior history of other cancers (except non-melanoma skin cancer or cervical intraepithelial neoplasia) with active disease within last 5 years
- Prior use of tucatinib before enrollment
- Hypersensitivity to tucatinib, trastuzumab, or capecitabine
- Currently pregnant or breastfeeding
- Use of strong CYP2C8 inhibitors or CYP3A4/CYP2C8 inducers shortly before first systemic therapy dose
- Myocardial infarction or unstable angina within 6 months before first systemic therapy dose
- Blood transfusions needed to meet eligibility criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
C
CLIMB-LMD Project Manager
CONTACT
D
Dr. Katarzyna Jerzak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here