NCT04220203Approved For Marketing不适用
A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
The purpose of this program is to provide access to tucatinib in the United States before FDA approval.
Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle.
To learn more about this program, contact Seattle Genetics' Medical Information (medinfo@seagen.com).
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
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