CTRI/2014/07/004722已完成3 期
Multicenter randomized double blind phase III clinical trial comparing safety and efficacy of BCD-022 (CJSC BIOCAD, Russia) used with paclitaxel to Herceptin® (F. Hoffmann-La Roche Ltd, Switzerland) used with paclitaxel in the first-line treatment of HER2-positive metastatic breast cancer patients.
BIOCAD INDIA PVT LTD0 个研究点目标入组 206 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
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.Written informed consent and ability to follow the Protocol procedures;
- •2.Age18 years and age 75 years;
- •3.Female gender;
- •4.Histologically confirmed breast cancer (BC);
- •5.Metastatic BC (stage IV according to TNM classification version 6);
- •6.Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH) ;
- •7.Documented results of oestrogen and progesterone receptors expression analysis;
- •8.ECOG status 0, 1 or 2, not increasing within 2 weeks prior to randomization;
- •9.Life expectancy â?? 20 weeks or more from the moment of randomization;
- •10.Presence of at least 1 tumour lesion with a size not less than 1 cm (revealed with CT slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour lesion are not eligible for the trial;
- •11.Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug .
排除标准
- •1. Previous anticancer therapy for metastatic BC, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous hormonal therapy is allowed;
- •2. Disease progression within 6 months after adjuvant and/or neoadjuvant BC therapy.
- •3. Surgery, radiation therapy, hormonal therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization.
- •4. Hypersensitivity to paclitaxel and all medications containing polyoxyethylated castor oil, hypersensitivity to dexamethasone, diphenhydramine, ranitidine/cimetidine, recombinant murine proteins, contrast agents or excipients of study medications;
- •5. BC metastases in CNS, progressing or clinically manifested (e.g. cerebral oedema, spinal cord injury), with exception of non-progressing metastases not requiring treatment with glucocorticosteroids and/or anticonvulsants within 4 weeks prior to randomization;
- •6. Cardiovascular system pathology (CHF stage III-IV according to NYHA classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization;
- •7. Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise);
- •8. Left ventricular ejection fraction <50% according to ECG;
- •9. Neutrophils <=1500/mm3;
- •10. Platelets <=100 000/mm3;
- •11. Hemoglobin <=90 g/L;
- •12. Creatinine level >= 1.5 Ã? upper limit of normal (ULN);
- •13. Bilirubin level >= 1.5 Ã? ULN;
- •14. AST and ALT levels >= 2.5 Ã? ULN (5 Ã? ULN for patients with liver metastases);
- •15. Alkaline phosphatase level >= 5 Ã? ULN;
- •16. Pregnancy or lactation;
- •17. Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;
- •18. Conditions limiting patientâ??s adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);
- •19. Stage II-IV neuropathy according to CTCAE v.4.0;
- •20. Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;
- •21. Acute or active chronic infections;
- •22. HCV, HBV, HIV or syphilis infections;
- •23. Obstacles in intravenous administration of study drugs.
研究者
相似试验
尚未招募
3 期
Phase III Study Comparing Gabapentin-Duloxetine Capsules to Pregabalin-Duloxetine Capsules for Neuropathic PaiCTRI/2024/07/071354Mr Surender Arora
进行中（未招募）
不适用
A randomized, double-blind multicenter phase III study of bevacizumab in combination with cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with advanced or recurrent non-squamous non-small cell lung cancer, who have not received prior chemotherapy - AvailAdvanced or recurrent non-squamous non-small cell lung cancer.MedDRA version: PTLevel: 7.0Classification code 10061873EUCTR2004-000864-29-CZF. Hoffmann-La Roche Ltd.1,050
进行中（未招募）
1 期
A randomized, double-blind multicenter phase III study of bevacizumab in combination with cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with advanced or recurrent non-squamous non-small cell lung cancer, who have not received prior chemotherapy - AvailEUCTR2004-000864-29-DEF. Hoffmann-La Roche Ltd.1,050
进行中（未招募）
不适用
A randomized, double-blind multicenter phase III study of bevacizumab in combination with cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with advanced or recurrent non-squamous non-small cell lung cancer, who have not received prior chemotherapy. - AvailAdvanced or recurrent non-squamous non-small cell lung cancer.MedDRA version: PTLevel: 7.0Classification code 10061873EUCTR2004-000864-29-GBF. Hoffmann-La Roche Ltd.1,050
进行中（未招募）
1 期
A study evaluating the efficacy and safety of BI 695502 plus chemotherapy versus Avastin® plus chemotherapy in patients with advanced nonsquamous Non-Small Cell Lung CancerRecurrent or metastatic disease (Stage IV), histologically or cytologically confirmed advanced nonsquamous Non-Small Cell Lung Cancer.MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-002161-30-HUBoehringer Ingelheim International GmbH671