CTRI/2015/10/006258已完成4 期
A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine In Indian Patients With Her2-Positive Unresectable Locally Advanced Or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab And A Taxane.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
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
入选标准
- •1.Male or female of age >= 18 years
- •2.Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene-amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site if primary tumor not available (ISH positivity is defined as a ratio of 2.0 or greater for the number of HER2 gene copies to the number of signals for CEP17, or for single probe tests, a HER2 gene count greater than 4) as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
- •3.Histologically or cytologically documented invasive breast cancer: unresectable, LABC or mBC
- •4.Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include:-
- •i.A taxane, alone or in combination with another agent, AND
- •ii.Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting
- •5.Documented progression of unresectable, locally advanced, or mBC, determined by the investigator; progression must occur during or after most recent treatment for LABC/mBC or within 6 months after completing adjuvant therapy
- •6.Measurable and/or non-measurable disease
- •7.LVEF >= 50% by echocardiogram (ECHO)
- •8.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •9.Adequate organ function, evidenced by the following laboratory results within 30 days of enrollment:
- •i.Absolute neutrophil count > 1,500 cells/mm3
- •ii.Platelet count > 100,000 cells/mm3
- •iii.Hemoglobin > 9.0 g/dL. Patients will be allowed to be transfused red blood cells to this level
- •iv.Albumin >= 2.5 g/dL
- •v.Total bilirubin <= 1.5 upper limit of normal (ULN)
- •vi.Serum glutamic oxaloacetic transaminase (SGOT) or aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT) or alanine aminotransferase (ALT), and alkaline phosphatase (ALP) <= 2.5 Ã? ULN with the following exception: Patients with bone metastases: ALP <= 5 Ã? ULN
- •vii.Creatinine clearance > 50 mL/min based on Cockroft-Gault glomerular filtration rate estimation: (140 â?? Age) Ã? (weight in kg) Ã? (0.85 if female)/(72 Ã? serum creatinine)
- •viii.International normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 Ã? ULN (unless on therapeutic coagulation)
- •10.A negative serum β-Human Chorinic Gonadotropin (β-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus) within 7 days prior to the first dose of study treatment with the result available prior to first dosing
- •11.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of ï?¼ 1% per year, during the treatment period and for at least 7 months after the last dose of study drug
- •A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (ï?³ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal
排除标准
- •1.Prior treatment with trastuzumab emtansine
- •2.Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab
- •3.Peripheral neuropathy of Grade >= 3 per NCI CTCAE (version 4.03)
- •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 enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria
- •6.History of exposure to the following cumulative doses of anthracyclines:
- •i.Doxorubicin or liposomal doxorubicin > 500 mg/m2
- •ii.Epirubicin > 900 mg/m2
- •iii.Mitoxantrone > 120 mg/m2
- •iv.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 enrollment. The patient must have recovered from any resulting acute toxicity (to Grade <= 1) prior to enrollment.
- •8.Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment
- •9.History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
- •10.History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes IIâ??IV) or serious cardiac arrhythmia requiring treatment
- •11.History of myocardial infarction or unstable angina within 6 months of enrollment
- •12.Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
- •13.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- •14.Pregnancy or lactation
- •15.Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines
- •16.Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
- •17.History of intolerance (such as Grade 3-4 infusion reaction) or known 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
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