Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT04220203
Eligibility Criteria:
Inclusion Criteria:
* Have histologically confirmed HER2+ breast carcinoma, with HER2+ defined by ISH or FISH or IHC methodology
* For patients WITHOUT presence or history of brain metastases, have received previous treatment with trastuzumab, pertuzumab, and T-DM1
* For patients WITH presence or history of brain metastases, have received previous treatment with trastuzumab
* Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by treating physician), or be intolerant of last systemic therapy
* Have measurable disease or non-measurable disease assessable by standard of care imaging methods
* Have ECOG PS 0 or 1
* Have a life expectancy of at least 6 months, in the opinion of the treating physician
Exclusion Criteria:
* Eligible for a tucatinib clinical trial
* Disease recurrence within 3 months of last capecitabine for metastatic disease
* History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the protocol drugs
* Have received treatment with any systemic anti-cancer therapy (excluding hormonal therapy), non-CNS radiation, or experimental agent ≤ 3 weeks of first dose of protocol treatment or are currently participating in an interventional clinical trial. Have received hormonal therapies \<1 week of the first dose of protocol treatment.
* Have any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
* Alopecia and neuropathy, which must have resolved to ≤ Grade 2
* CHF, which must have been ≤ Grade 1 in severity at the time of occurrence, and must have resolved completely
* Anemia, which must have resolved to ≤ Grade 2
* Have clinically significant cardiopulmonary disease
* Have known myocardial infarction or unstable angina within 6 months prior to first dose of protocol treatment
* Are known carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease with uncontrolled disease
* Are known to be positive for HIV with uncontrolled disease
* Are pregnant, breastfeeding, or planning a pregnancy
* Require therapy with warfarin or other coumarin derivatives (non-coumarin anticoagulants are allowed)
* Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications
* Have used strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or have used a CYP2C8 or CYP3A4 inducer within 5 day prior to start of tucatinib treatment.
* Have known dihydropyrimidine dehydrogenase deficiency
* Have evidence within 2 years of the start of protocol treatment of another malignancy that required systemic treatment.
CNS Exclusion - patients must not have any of the following:
* Any untreated brain lesions \> 2.0 cm in size, unless discussed with medical monitor and approval for enrollment is given
* Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \> 2 mg of dexamethasone (or equivalent). However, patients on a chronic stable dose of ≤ 2 mg total daily of dexamethasone (or equivalent) may be eligible with discussion and approval by the medical monitor
* Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions).
* Known or suspected LMD as documented by the treating physician
* Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04220203
Study Brief:
Protocol Section:
NCT04220203