A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer - HER2CLIMB-05

Seagen B.V.0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月9日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Subjects must meet the following criteria to be eligible for the study:
•1. Have centrally confirmed HER2+ breast carcinoma according to 2018
•American Society of Clinical Oncologists (ASCO)-College of American
•Pathologists (CAP) guidelines prior to randomization (defined as a 3+
•score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent
•positive by ISH).
•2. Have unresectable locally advanced or metastatic (hereafter referred
•to as advanced) disease; if recurrent (after [neo]adjuvant therapy),
•there must be a minimum 6-month treatment-free interval from any
•trastuzumab and pertuzumab received in the early breast cancer setting
•to the diagnosis of advanced HER2+ disease. Prior standard of care
•therapy for early breast cancer is permitted (eg, prior T-DM1); however,
•Exclusion Criterion 1 should be noted.
•3. Have received 4-8 cycles of pre-study induction therapy including only
•trastuzumab, pertuzumab, and taxane as first-line therapy for the
•treatment of advanced breast cancer prior to study enrollment. Subjects
•are eligible provided they are without evidence of disease progression
•(per investigator judgement) ie, CR, PR, or SD) following completion of
•induction therapy.
•a. Subjects receiving <6 cycles (ie, 4-5 cycles) of taxane are only eligible
•if the taxane was stopped early due to intolerable toxicity (eg,
•documented neuropathy impacting function).
•b. Subjects are permitted to receive trastuzumab and pertuzumab for 1
•additional cycle (after completion of chemotherapy) during screening to
•allow completion of screening procedures. Study treatment should begin
•within 6 weeks (± 3 days) from the start of the last cycle of trastuzumab
•and pertuzumab.
•c. Subjects are permitted to receive up to 2 cycles of carboplatin during
•the start of induction therapy in combination with trastuzumab,
•pertuzumab , and taxane (eg, to obtain confirmation of metastatic breast
•cancer diagnosis)
•d. Subjects who received traditional medications (eg, traditional Chinese
•medication) and/or supplements with potential anti-cancer effects
•during induction therapy will remain eligible if they discontinue these
•treatments at least 4 weeks prior to the start of study treatment.
•4. Known hormone receptor status (per local guidelines; may be
•hormone receptor positive [HR+] or negative [HR-])
•5. Be at least 18 years of age, and legally an adult at time of consent and
•>= the age of majority per regional requirements
•6. Have Eastern Cooperative Oncology Group Performance Status (ECOG
•PS) of 0 or 1
•7. Have adequate hepatic function as defined in the protocol
•8. Have adequate baseline hematologic parameters as defined in the
•9. Have a serum or plasma creatinine <=1.5 X institutional ULN.
•10. Have left ventricular ejection fraction (LVEF) >=50% as assessed by
•echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
•documented within 4 weeks prior to first dose of study treatment.
•11. Subjects of childbearing potential must meet the conditions as per
•12. Male subjects must meet the conditions as per protocol
•13. Provide signed informed consent per a consent document that has
另有 3 项未显示

排除标准

•Subjects will be excluded from the study for any of the following reasons:
•1. Have previously been treated with any tyrosine kinase inhibitor
•targeting anti-HER2 and/or anti-epidermal growth factor receptor
•(EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib,
•neratinib, and afatinib (except neratinib if given in extended adjuvant
•setting and at least 12 months have elapsed from the last neratinib dose
•to the start of study drug) or are currently participating in another
•interventional clinical trial
•2. Unable for any reason to undergo contrast-enhanced MRI of the brain
•3. History of allergic reactions to trastuzumab, pertuzumab, or
•compounds chemically or biologically similar to tucatinib, except for
•Grade 1 or 2 infusion-related reactions (IRRs) to trastuzumab that were
•successfully managed, known allergy to one of the excipients in the study
•drugs, or hypersensitivity to murine proteins
•4. Are positive for active Hepatitis B by surface antigen expression,
•positive for Hepatitis C infection, or the presence of known chronic liver
•disease. Subjects who have been treated for Hepatitis C infection are
•permitted if they have documented sustained virologic response of at
•least 12 weeks, as documented per local guidelines. The latest local
•guidelines should be followed regarding the testing of Hepatitis B DNA
•levels by polymerase chain reaction (PCR). Subjects with Hepatitis B
•DNA levels by PCR that require nucleoside analogue or other therapies 4. Are
•positive for active Hepatitis B by surface antigen expression,
•positive for Hepatitis C infection, or the presence of known chronic liver
•disease. Subjects who have been treated for Hepatitis C infection are
•permitted if they have documented sustained virologic response of at
•least 12 weeks, as documented per local guidelines. The latest local
•guidelines should be followed regarding the testing of Hepatitis B DNA
•levels by polymerase chain reaction (PCR). Subjects with Hepatitis B
•DNA levels by PCR that require nucleoside analogue or other therapies4. Are
•positive for active Hepatitis B by surface antigen expression,
•positive for Hepatitis C infection, or the presence of known chronic liver
•disease. Subjects who have been treated for Hepatitis C infection are
•permitted if they have documented sustained virologic response of at
•least 12 weeks, as documented per local guidelines. The latest local
•guidelines should be followed regarding the testing of Hepatitis B DNA
•levels by polymerase chain reaction (PCR). Subjects with Hepatitis B
•DNA levels by PCR that require nucleoside analogue or other therapies are not
•eligible for the trial.
•5. Subjects known to be positive for human immunodeficiency virus (HIV) are
•excluded if they meet any of the following criteria:
•a. CD4+ T cell count of <350 cells/µL
•b. Detectable HIV viral load
•c. History of an opportunistic infection within the past 12 months
•d. On stable antiretroviral therapy for <4 weeks
•6. Are pregnant, breastfeeding, or planning a pregnancy from time of informed
•consent until 7 months after the final dose of study drug
•7. Have inability to swallow pills or have significant gastrointestinal disease
•or surgery which would preclude the adequate oral absorption of medications
•8. Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or

研究者

发起方

Seagen B.V.

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