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This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab + 2nd Line Chemotherapy | Experimental |
| |
| Only Chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second line chemotherapy | Drug | As prescribed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Disease Progression | Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sofia | 1527 | Bulgaria | ||||
Of 114 participants screened, 3 participants were screening failures. The reasons for screening failure were violation of inclusion criteria, refused to take part in the study and bacterial infection. Therefore, 111 participants were randomized to receive study treatment. Two participants were randomized but never started study treatment.
A total of 114 participants were enrolled in this study conducted from March 2007 to August 2011 at 30 centers in 8 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab + 2nd Line Chemotherapy | Eligible participants were administered trastuzumab (Herceptin) 6 milligrams per kilograms (mg/kg) of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous (IV) infusion every three weeks until disease progression, unacceptable toxicities, or withdrawal from study, in combination with second line chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| trastuzumab [Herceptin] | Drug | 6mg/kg iv every 3 weeks |
|
| Up to 5 years |
| Clinical Benefit Rate | Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : >=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Up to 5 years |
| Median Time to Treatment Failure | Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Up to 5 years |
| Overall Survival | Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Up to 5 years |
| Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Up to 5 years |
| Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels | Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years) |
| Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels | Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years) |
| Biochemistry Safety Laboratory Parameters: Mean Albumin Levels | Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years) |
| Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels | Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years) |
| Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels | Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
| Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts | Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
| Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts | Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments. Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
| Hematology Safety Laboratory Parameter: Mean Platelets Counts | Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
| Mean Left Ventricular Ejection Fraction | Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years). | Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years). |
| Tallinn |
| 13419 |
| Estonia |
| Budapest | 1082 | Hungary |
| Budapest | 1115 | Hungary |
| Budapest | 1122 | Hungary |
| Budapest | 1125 | Hungary |
| Budapest | 1135 | Hungary |
| Budapest | 1145 | Hungary |
| Debrecen | 4032 | Hungary |
| Győr | 9023 | Hungary |
| Gyula | 5700 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Szeged | 6725 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szombathely | 9700 | Hungary |
| Haifa | 31096 | Israel |
| Holon | 58100 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 52621 | Israel |
| Rehovot | 76100 | Israel |
| Safed | 13110 | Israel |
| Tel Aviv | 6423906 | Israel |
| Ẕerifin | 70300 | Israel |
| Kaunas | 50009 | Lithuania |
| Vilnius | 08660 | Lithuania |
| Skopje | 1000 | North Macedonia |
| Bratislava | 812 50 | Slovakia |
| Košice | 041 90 | Slovakia |
| Adana | 01330 | Turkey (Türkiye) |
| Ankara | 06590 | Turkey (Türkiye) |
| FG001 | Only Chemotherapy | Eligible participants were administered second line chemotherapy according to the investigator's decision. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Population included all participants who entered the trial and received at least one dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab + 2nd Line Chemotherapy | Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy. |
| BG001 | Only Chemotherapy | Eligible participants were administered second line chemotherapy according to the investigator's decision. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Time to Disease Progression | Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. n = Numbers of participants included in this analysis. | Posted | Median | 95% Confidence Interval | Days | Up to 5 years |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Full-Analysis-Set participants with measurable disease with CR or PR | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 5 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate | Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : >=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Full-Analysis-Set participants with measurable disease with CR, PR and SD. Study design was changed to single arm study because herceptin use after progression herceptin-based therapy become widespread. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 5 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Median Time to Treatment Failure | Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants who experienced treatment failure were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 5 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants with data available were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 5 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. | Posted | Number | Number of participants | Up to 5 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels | Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | Units per liter | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels | Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | Micromole/liter | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Biochemistry Safety Laboratory Parameters: Mean Albumin Levels | Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | gram per liter | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels | Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | Millimole per liter | Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels | Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | grams per deciliter | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts | Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | 10^9 leukocytes/L | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts | Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments. Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | percent of differential | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Hematology Safety Laboratory Parameter: Mean Platelets Counts | Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | Number of cells x 10^9/L | Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Left Ventricular Ejection Fraction | Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years). | The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point. | Posted | Mean | Standard Deviation | percent of blood pumped from LV chamber] | Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years). |
|
|
Up to 5 years
The Safety Population included all participants who entered the trial and received at least one dose of trial medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab + 2nd Line Chemotherapy | Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy. | 20 | 93 | 81 | 93 | ||
| EG001 | Only Chemotherapy | Eligible participants were administered second line chemotherapy according to the investigator's decision. | 2 | 16 | 9 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Infusion site inflammation | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
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