EUCTR2019-005017-39-DE进行中（未招募）1 期
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Seagen Inc.
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed HER2+ breast carcinoma, as determined by sponsor-designated central laboratory testing on tumor tissue submitted prior to randomization, from archival tissue or a newly-obtained baseline biopsy of an accessible tumor lesion that has not been previously irradiated is required
- •2. History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination. Prior pertuzumab therapy is allowed, but not required.
- •3. Have progression of unresectable LA/M breast cancer after last systemic therapy, or be intolerant of last systemic therapy
- •4. Measurable or non-measurable disease assessable by RECIST v1.1
- •5. HR (estrogen receptor [ER]/ progesterone receptor [PR]) status must be known prior to randomization
- •6. Age =18 years at time of consent or = the age of majority in the
- •geographic location
- •7. ECOG performance status score of 0 or 1
- •8. Life expectancy =6 months, in the opinion of the investigator
- •9. Adequate hepatic function (refer to protocol)
- •10. Adequate baseline hematologic parameters (refer to protocol)
- •11. Estimated glomerular filtration rate (GFR) =50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) study equation as applicable
- •12. International normalized ratio (INR) and partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) = 1.5 X ULN, unless on medication known to alter INR and PTT/aPTT.
- •13. Left ventricular ejection fraction (LVEF) =50% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study treatment
- •14. For subjects of childbearing potential the following stipulations apply:
- •a. Must have a negative serum or urine pregnancy test result within 7 days prior to the first dose of study treatment. A subject with a false positive result and documented verification that the subject is not pregnant is eligible for participation.
- •b. Must agree not to try to become pregnant during the study and for at least 7 months after the final dose of study drug administration
- •c. Must agree not to breastfeed or donate ova, starting at time of informed consent and continuing through 7 months after the final dose of study drug administration
- •d. If sexually active in a way that could lead to pregnancy, must consistently use 2 highly effective methods of birth control starting at
- •the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study drug administration.
- •15. For subjects who can father children, the following stipulations
- •a. Must agree not to donate sperm starting at time of informed consent and continuing throughout the study period and for at least 7 months after the final study drug administration
- •b. If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use 2 highly effective
- •methods of birth control starting at time of informed consent and
- •continuing throughout the study and for at least 7 months after the final dose of study drug administration.
- •c. If sexually active with a person who is pregnant or breastfeeding,
- •must consistently use 1 of 2 highly effective methods of birth control
- •starting at time of informed consent and continuing throughout the
- •study and for at least 7 months after the final dose of study drug
- •administration
- •16. The subject must provide written informed consent
- •17. Subject must be willing and able to comply with study proc
排除标准
- •1.Prior treatment with tucatinib,afatinib,trastuzumab deruxtecan
- •(DS8201a), or any other investigational anti-HER2,anti-EGFR, or HER2
- •TKI agent. Prior treatment with lapatinib or neratinib within 12months of starting study treatment (except in cases where they were given for=21 days and discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent or mBC(except in cases where pyrotinib was given for=21 days and discontinued for reasons other than disease progression or severe toxicity).
- •2.Prior treatment with T-DM1 in any treatment setting.
- •3.History of allergic reactions to trastuzumab or compounds chemically or biologically similar to tucatinib, except for Grade1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to any of the excipients in the study drugs
- •4. Treatment with any systemic anti-cancer therapy (including hormonal therapy),non-CNS radiation (palliative or therapeutic), experimental agent or participation in another interventional clinical trial=3weeks prior to first dose of study treatment. An exception for the washout of hormonal therapies is gonadotropin releasing hormone agonists used for ovarian suppression in premenopausal women, which are permitted concomitant medications.
- •5. Any toxicity related to prior cancer therapies that has not resolved to = Grade 1, with the following exceptions:
- •- Alopecia;
- •- Neuropathy, which must have resolved to=Grade2;
- •- Congestive heart failure(CHF), which must have been = Grade 1 in severity at the time of occurrence, and must have resolved completely
- •6.Clinically significant cardiopulmonary disease such as:
- •-Ventricular arrhythmia requiring therapy
- •-Symptomatic hypertension or uncontrolled asymptomatic hypertension as determined by the investigator
- •-Any history of symptomatic CHF, symptomatic left ventricular systolic
- •dysfunction or symptomatic decrease in ejection fraction
- •-For France and Italy only: Any history of interstitial lung disease or pneumonitis
- •-Severe dyspnea at rest([CTCAE]Grade3 or above) due to complications of advanced malignancy or hypoxia requiring supplementary oxygen therapy
- •- = Grade 2QTc prolongation on screening electrocardiogram(ECG)
- •7.Known myocardial infarction or unstable angina within 6months prior to first dose of study treatment
- •8.Known carrier of Hepatitis B or Hepatitis C or has other known chronic
- •liver disease
- •- For Italy: positive for 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 of12weeks. 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 therapy are not eligible for the trial.
- •9. Subjects known to be positive for human immunodeficiency virus
- •(HIV) if they meet any of the following criteria:
- •?CD4+T-cell count of <350 cells/µL
- •?Detectable HIV viral load
- •?History of an opportunistic infection within the past 12 months
- •?On stable antiretroviral therapy for<4 weeks
- •10. Subjects who are pregnant, breastfeeding, or planning to become pregnant from time of informed consent until 7months following the last dose of study drug
- •11.Unable to swallow pills or has significant gastrointestinal disease w
研究者
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