A multicenter, single arm 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 - T-DM1 (Global Safety Study)

Roche Nederland B.V.0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Roche Nederland B.V.
入组人数: 30

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

•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.

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, or cancers with a similar curative outcome as those mentioned above;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

发起方

Roche Nederland B.V.

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