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4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: 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. Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: BC metastases in central nervous system, 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: 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); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Left ventricular ejection fraction <50% according to electrocardiography; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Neutrophils 1500/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Platelets 100 000/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Hemoglobin 90 g/L; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Creatinine level 1.5 × upper limit of normal (ULN); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Bilirubin level 1.5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Alkaline phosphatase level 5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Pregnancy or lactation; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Acute or active chronic infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Hepatitis C virus, hepatitis B virus, HIV or syphilis infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: PRIOR CONCURRENT THERAPY: secondary trial: Obstacles in intravenous administration of study drugs Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Written informed consent and ability to follow the Protocol procedures; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Age from 18 years to 75 years inclusive; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Female gender; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Histologically confirmed breast cancer (BC); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Metastatic BC (stage IV according to TNM classification version 6); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: 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) ; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Documented results of oestrogen and progesterone receptors expression analysis; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Life expectancy - 20 weeks or more from the moment of randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: 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. Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: BC metastases in central nervous system, 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: 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); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Left ventricular ejection fraction <50% according to electrocardiography; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Neutrophils 1500/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Platelets 100 000/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Hemoglobin 90 g/L; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Creatinine level 1.5 × upper limit of normal (ULN); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Bilirubin level 1.5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Alkaline phosphatase level 5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Pregnancy or lactation; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Acute or active chronic infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Hepatitis C virus, hepatitis B virus, HIV or syphilis infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Any number of prior chemotherapy regimens for metastatic breast cancer allowed secondary trial: Obstacles in intravenous administration of study drugs Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Written informed consent and ability to follow the Protocol procedures; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Age from 18 years to 75 years inclusive; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Female gender; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Histologically confirmed breast cancer (BC); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Metastatic BC (stage IV according to TNM classification version 6); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: 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) ; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Documented results of oestrogen and progesterone receptors expression analysis; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Life expectancy - 20 weeks or more from the moment of randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: 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. Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: BC metastases in central nervous system, 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: 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); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Left ventricular ejection fraction <50% according to electrocardiography; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Neutrophils 1500/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Platelets 100 000/mm3; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Hemoglobin 90 g/L; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Creatinine level 1.5 × upper limit of normal (ULN); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Bilirubin level 1.5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Alkaline phosphatase level 5 × ULN; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Pregnancy or lactation; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: 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; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Acute or active chronic infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Hepatitis C virus, hepatitis B virus, HIV or syphilis infections; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed secondary trial: Obstacles in intravenous administration of study drugs Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: Written informed consent and ability to follow the Protocol procedures; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: Age from 18 years to 75 years inclusive; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: Female gender; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: Histologically confirmed breast cancer (BC); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: Metastatic BC (stage IV according to TNM classification version 6); Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: 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) ; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: Documented results of oestrogen and progesterone receptors expression analysis; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |
4db02d9b-d96e-4ced-947c-71cebcccc933 | primary trial: More than 28 days since prior and no concurrent systemic oral steroids secondary trial: Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization; Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial. | 1 |