OncoMatch/Clinical Trials/NCT06016387
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
Is NCT06016387 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tucatinib 150 MG and Trastuzumab for her2-positive breast cancer.
Treatment: Tucatinib 150 MG · Trastuzumab · Capecitabine — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (HER2+ as per ASCO-CAP 2018 guidelines)
HER2+ status will be defined in accordance with ASCO-CAP 2018 guidelines
Required: HER2 (ERBB2) mutation
HER2 mutations ... can be identified in the blood and/or cerebrospinal fluid (CSF) at any time prior to enrolment
Required: HER2 (ERBB2) amplification
HER2-amplifications can be identified in the blood and/or cerebrospinal fluid (CSF) at any time prior to enrolment
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: whole brain radiotherapy
Prior WBRT for brain metastases
Cannot have received: stereotactic radiosurgery
Exception: if received <7 days prior to consent
prior stereotactic radiosurgery for parenchymal CNS metastases received <7 days prior to consent
Cannot have received: therapy specifically directed at LMD (radiotherapy or systemic therapy)
Prior therapy specifically directed at LMD, including prior radiotherapy or systemic therapy
Cannot have received: tucatinib (tucatinib)
Prior use of tucatinib at any time prior to enrollment
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL; ANC ≥ 1 x10^9/L; Platelets ≥ 100 x10^9/L
Kidney function
Creatinine clearance (CrCL) ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 X ULN; AST and ALT ≤ 2.5X ULN; INR and aPTT ≤ 1.5 X ULN
Cardiac function
LVEF must be within institutional limits of normal as assessed by ECHO or MUGA
LVEF must be within institutional limits of normal as assessed by ECHO or MUGA documented within 2 weeks prior to starting systemic therapy on the study; Adequate hematologic, liver, and renal function within 2 weeks prior to phase 2 enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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