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New treatment option for HER2-positive Breast Cancer
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
ClinicalTrials.gov ID: NCT06016387
What this study is testing
What is Tucatinib 150 MG?
Tucatinib 150 MG is an investigational medicine, being studied as a potential treatment for her2-positive breast cancer.
Also referred to as Tukysa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase 1
- 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...
- Evidence of LMD\ in the brain and/or spine (either positive cerebral spinal fluid cytology and/or magnetic resonance imaging evidence of LMD)...
- Age 18+ at time of consent;
- ECOG ≤ 2;
You likely can't join if
- Phase 1
- Prior WBRT for brain metastases (prior stereotactic radiosurgery for parenchymal CNS metastases received \<7 days prior to consent );
- 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...
- Diagnosed with Hereditary fructose intolerance;
See the full eligibility criteria
- Phase 1
- 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...
- 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...
- 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. Phase 2: 1. Left ventricular ejection fraction (LVEF)...
- Adequate hematologic, liver, and renal function within 2 weeks prior to phase 2 enrollment, as follows:
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1 x109/L
- Platelets ≥ 100 x109/L
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
- AST and ALT ≤ 2.5X ULN
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN
- Creatinine clearance (CrCL) ≥ 50 mL/min
- The last dose of prior therapy must have been completed 14 days prior to study enrollment. Prior chemotherapy, immunotherapy, endocrine therapy, targeted therapy and experimental agents are allowed (including prior use...
- Phase 1
- Prior WBRT for brain metastases (prior stereotactic radiosurgery for parenchymal CNS metastases received \<7 days prior to consent );
- 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...
- 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.
- Hypersensitivity to any of the active substances in tucatinib, trastuzumab, or capecitabine. Phase 2:
- Currently pregnant or breastfeeding;
- Use of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to the first dose of systemic therapy (see Appendix C and D);
- Myocardial infarction or unstable angina within 6 months prior to the first dose of systemic therapy.
- Blood product transfusions in order to meet eligibility criteria
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.