A randomised, multicentre, open-label Phase II trial investigating activity of chemotherapy and lapatinib and Trastuzumab in patients with HER2-positive metastatic breast cancer (MBC) refractory to anti HER2 therapies - TYPHER (TYverb Plus HERceptin in metastatic breast cancer)

Consorzio Oncotech0 个研究点开始时间: 2014年5月16日最近更新: 2015年3月30日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Consorzio Oncotech

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 clinical trial of medicinal product

入排标准

性别: Female

入选标准

•1.Histological or cytological confirmed and documented adenocarcinoma of the breast with metastatic disease;
•2.The original tumour specimen must be HER2 IHC 3+ positive or, in case of IHC 2+, a FISH amplification ratio > 2.0. HER2 status determined locally as defined by institutional criteria. IHC and FISH testing will be used to HER2 assessment;
•3.Age =18;
•4.Life expectancy of >12 weeks;
•5.ECOG PS 0-1;
•6.Measurable disease as defined by RECIST1.1 criteria;
•7.All patients must have received prior anthracycline-and taxane-based regimens as well as trastuzumab based regimens in either the adjuvant or the metastatic setting. Patients must have been already treated with at least one line of the anti HER2 inhibitor therapy lapatinib for their metastatic breast cancer. A maximum of three previous lines of anti-HER-2 therapies in the metastatic setting are allowed;
•8.Adequate haematological function as defined by: ANC ? 1.5 x 109/L, platelet count ?100 x 109/L, haemoglobin ? 10 g/dL;
•9.Adequate renal function, as defined by: creatinine? 1.5 x UNL;
•10.Adequate hepatobiliary function, as defined by the following baseline liver function tests: total serum bilirubin ?1.5 upper normal limit (UNL); alanine amino transferase (ALT), aspartate amino transferase (AST) ? 2.5xUNL; alkaline phosphatase (AP) ? 2.5xUNL; if total alkaline phosphatase (AP) > 2.5xUNL, alkaline phosphatase liver fraction must be ? 2.5xUNL;
•11.Adequate contraception for all fertile patients;
•12.Negative pregnancy test;
•13.Postmenopausal women fulfilling any of the NCCN criteria may be included;
•14.Left ventricular ejection fraction (LVEF) =50% during a baseline period of 28 days, as determined by either echocardiography (ECHO) or multi gated acquisition (MUGA) scan. ECHO is the preferred method; the same method of LVEF assessment, ECHO or MUGA, must be used throughout the study and, to the extent possible, be obtained at the same institution. Assessments made within 42 days prior to randomisation are not required to be repeated;
•15.Signed, written informed consent (approved by the institutional review board or independent ethics committee) obtained prior to any study specific procedure initiation or treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements;
•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 154
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 154

排除标准

•1.Patients presenting with stage IV MBC at first diagnosis of breast cancer are NOT eligible
•2.History of persistent Grade = 2 hematologic toxicity resulting from previous systemic therapy
•3.Current peripheral neuropathy of NCI-CTCAE, Version 3.0, Grade = 3 at randomization
•4.History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
•5.Bone-only disease, unless a measurable lesion is evident as determined by RECIST v1.1 (Eisenhauer et al. 2009):
•6.Bone scan, PET scan or plain films are not considered adequate imaging techniques to measure bone lesions. Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that can be evaluated by cross-sectional imaging techniques such as CT or MRI can be considered as measurable lesions if the soft tissue component meets the definition of measurability described above
•7.Blastic bone lesions are non-measurable.
•8.Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA) / stroke within =6 months prior to the first study treatment, myocardial infarction within =6 months prior to the first study treatment, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication
•9.Current dyspnoea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy.
•10.Inadequate organ function, evidenced by the following laboratory results within 28 days prior to randomization:
•Inadequate bone marrow function
•-Absolute neutrophil count <1,500 cells/mm3
•-Platelet count <100,000 cells/mm3
•-Haemoglobin <9 g/dL
•Inadequate liver function
•-Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilbert’s syndrome)
•-AST (SGOT) or ALT (SGPT) >1.5 times ULN with concurrent serum alkaline phosphatase >2.5 times ULN (unless bone metastases are present).
•Inadequate renal function
•-Serum creatinine>2.0 mg/dL or >177 µmol/L
•-International normalised ratio and activated partial thromboplastin time or partial thromboplastin time >1.5 times ULN (unless on therapeutic coagulation).
•11.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures)
•12.Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
•13.History of receiving any investigational treatment within 28 days of randomization
•14.Current known infection with HIV, HBV, or HCV
•15.Receipt of IV antibiotics for infection within 14 days of randomization
•16.Known hypersensitivity to any of the study drugs
•17.Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
•18.Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
•19.Concurrent interventional or non-interventional studies

研究者

发起方

Consorzio Oncotech

相似试验

进行中（未招募）

1 期

A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIABeta-thalassemia major (TM) or Diamond Blackfan anemia (DBA) or myelodysplastic syndromes (MDS) (low and INT-1 risk as per the IPSS for MDS) or sideroblastic anemia and myocardial iron overload as indicated by a T2* =6 but not greater than 20 ms, with no symptoms of cardiac dysfunction, and an MRI measured LVEF =56%.

EUCTR2007-000766-20-GBovartis Pharma Services AG197

进行中（未招募）

不适用

EUCTR2007-000766-20-ITOVARTIS FARMA192

招募中

1 期

Study evaluating AGuIX® nanopartcles in combinaison with radiotherapy for progressive / recurrent inoperable musculoskeletal tumor lesion.

EUCTR2021-000571-37-FRCentre Léon Bérard132

进行中（未招募）

1 期

Clinical trial comparing the safety and efficacy of pimasertib and dacarbazine in previously untreated patients with locally advanced or metastatic malignant cutaneous melanoma showing the so-called N-Ras mutation.-RAS mutated locally advanced or metastatic malignant cutaneous melanomaMedDRA version: 18.1Level: LLTClassification code 10025655Term: Malignant melanoma of skinSystem Organ Class: 100000004864

EUCTR2012-002669-37-DEMerck Serono S.A. Geneva184

进行中（未招募）

1 期

Clinical trial comparing the safety and efficacy of pimasertib and dacarbazine in previously untreated patients with locally advanced or metastatic malignant cutaneous melanoma showing the so-called N-Ras mutation.-RAS mutated locally advanced or metastatic malignant cutaneous melanomaMedDRA version: 18.0Level: LLTClassification code 10025655Term: Malignant melanoma of skinSystem Organ Class: 100000004864

EUCTR2012-002669-37-NLMerck Serono S.A. Geneva184