EUCTR2019-005017-39-DK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
- •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
- •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
- 另有 8 项未显示
排除标准
- •1. Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-
- •8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI
- •agent. Prior treatment with lapatinib or neratinib within 12 months 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
- •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 Grade 1 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 =3 weeks
- •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 = Grade 2;
- •- 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 (Common Terminology Criteria for Adverse
- •Events [CTCAE] Grade 3 or above) due to complications of advanced
- •malignancy or hypoxia requiring supplementary oxygen therapy
- •- = Grade 2 QTc prolongation on screening electrocardiogram (ECG)
- •7. Known myocardial infarction or unstable angina within 6 months 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 of 12
- •weeks. 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.
- 另有 8 项未显示
研究者
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