Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients W… (NCT06016387) | Clinical Trial Compass
RecruitingPhase 2
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
Canada30 participantsStarted 2023-11-25
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or women with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer. HER2+ status will be defined in accordance with ASCO-CAP 2018 guidelines, and can be diagnosed at any time prior to enrolment. HER2 mutations and/or HER2-amplifications can be identified in the blood and/or cerebrospinal fluid (CSF) at any time prior to enrolment; testing blood and/or CSF is not part of the study protocol and must be evaluated using a clinically validated test.
✓. Evidence of LMD\* in the brain and/or spine (either positive cerebral spinal fluid cytology and/or magnetic resonance imaging evidence of LMD). Measurable disease in the central nervous system is not required. \* The diagnosis of LMD can occur at any time prior to enrolment;
✓. Age 18+ at time of consent;
✓. ECOG ≤ 2;
✓. More than 14 days or 5 half-lives from the last dose of any experimental agent is required, whichever is greater;
✓. All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1 prior to enrollment, except for alopecia; neuropathy, must have resolved to ≤ Grade 2.
✓. Left ventricular ejection fraction (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, as follows:
Exclusion criteria
✕. Prior WBRT for brain metastases (prior stereotactic radiosurgery for parenchymal CNS metastases received \<7 days prior to consent );
What they're measuring
1
Survival status from the start of XRT
Timeframe: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
✕. Prior therapy specifically directed at LMD, including prior radiotherapy or systemic therapy;
✕. Inability to comply with MRI-based surveillance of CNS disease;
✕. Inability to swallow pills or any significant gastrointestinal diseases such as inflammatory bowel disease who suffer from uncontrolled diarrhea (based on the investigator's assessment),, which would preclude adequate absorption of oral medications;
✕. Diagnosed with Hereditary fructose intolerance;
✕. Diagnosed with Gilbert's disease;
✕. Prior history of other cancer (except non melanoma skin, cervical intraepithelial neoplasia) with evidence of disease within the last 5 years;
✕. Prior use of tucatinib at any time prior to enrollment.