EUCTR2012-001628-37-BG进行中（未招募）1 期
A TWO-COHORT, OPEN-LABEL, MULTICENTER, STUDY OF TRASTUZUMAB EMTANSINE (T-DM1) IN HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER PATIENTS WHO HAVE RECEIVED PRIOR ANTI-HER2 AND CHEMOTHERAPY-BASED TREATMENT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,220
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. HER2-positive disease determined locally i.e., IHC 3 + and/or gene-amplified by in-situ hybridization (ISH) as per institutional practice, (however, both tests should be performed wherever possible and only one positive result is required for eligibility)
- •2. Histologically or cytologically confirmed invasive BC
- •3. Prior treatment for BC in the advanced/metastatic, unresectable locally advanced or metastatic setting must include an anti-HER2 agent and chemotherapy in combination or sequential administration (complementary hormonal therapy is allowed)
- •4. Documented progression of incurable, unresectable, locally advanced, or mBC, defined by the investigator: progression must occur during or after most recent treatment for locally advanced/mBC or within 6 months after completing adjuvant therapy
- •5. Measurable and/or non-measurable disease
- •6. Signed written informed consent approved by the institution’s independent Ethics Committee (EC)
- •7. Age = 18 years
- •8. Left ventricular ejection fraction = 50% by either ECHO or MUGA
- •9. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- •10. Adequate organ function
- •11. For women of childbearing potential and men with partners of childbearing potential agreement by the patient and/or partner to use a highly effective non-hormonal form of contraception.
- •12. Negative serum pregnancy test for women of childbearing potential and for all women not meeting the definition of postmenopausal, and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential.
- •13. For Cohort 2, only patients of Asian race will be enrolled
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1909
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 311
排除标准
- •1. History of treatment with trastuzumab emtansine
- •2. Prior enrolment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not
- •3. Peripheral neuropathy of Grade = 3 per NCI CTCAE Version 4.0
- •4. History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer
- •5. History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria
- •6. History of exposure to the following cumulative doses of anthracyclines:
- •Doxorubicin or liposomal doxorubicin > 500 mg/m2
- •Epirubicin > 900 mg/m2
- •Mitoxantrone >120 mg/m2
- •If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
- •7. History of radiation therapy within 14 days of first study treatment. The patient must have recovered from any resulting acute toxicity (to Grade = 1) prior to first study treatment.
- •8. Metastatic CNS disease only
- •9. Brain metastases which are symptomatic. NOTE: A 14 days window after end of radiotherapy must be observed. Patient must not be receiving steroids to control symptoms.
- •10. History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment
- •11. History of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
- •12. History of myocardial infarction or unstable angina within 6 months of first study treatment
- •13. Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
- •14. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- •15. Pregnancy or lactation
- •16. Currently known active infection with HIV, hepatitis B virus, or hepatitis C virus
- •17. History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product
- •18. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol throughout
研究者
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