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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-US-S359 |
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The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2+ | Experimental | Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. |
|
| HER2- (Taxane-) | Experimental | Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). |
|
| HER2- (Taxane+) | Experimental | Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Tumor Response | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to disease progression/recurrence (up to 3.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed. | date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46203 |
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| ID | Title | Description |
|---|---|---|
| FG000 | HER2+ | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Carboplatin | Drug | Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
|
|
| Herceptin | Drug | Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). |
|
| Number of Patients Who Experienced Alopecia | Baseline to 3.5 years |
| Time to Disease Progression (TTP) | If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death. | randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years) |
| Percentage of Patients With Overall Survival at 1 Year and 2 Years | Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years. | 1 Year, 2 Years |
| United States |
| FG001 | HER2- (Taxane-) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| FG002 | HER2- (Taxane+) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HER2+ | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). |
| BG001 | HER2- (Taxane-) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| BG002 | HER2- (Taxane+) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| BG003 | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
| |||||||||||||||
| Race/Ethnicity | Number | 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 | Overall Tumor Response | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | Efficacy evaluable subjects include all subjects who received at least 2 cycles of treatment with at least 1 follow-up tumor assessment, and did not violate the protocol in any fundamental manner related to the evaluation of efficacy. | Posted | Number | participants | baseline to disease progression/recurrence (up to 3.5 years) |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed. | Number of patients with complete or partial response. Censored patients: 6 in HER2+, 6 in HER2- (Taxane-), and 5 in HER2- (Taxane+). | Posted | Median | Full Range | months | date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Experienced Alopecia | Number of patients who received at least one dose of study drug. | Posted | Number | participants | Baseline to 3.5 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression (TTP) | If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death. | Intent to treat population: all randomized patients. Censored patients: 10 in HER2+, 20 in HER2- (Taxane-), and 12 in HER2- (Taxane+). | Posted | Median | 95% Confidence Interval | months | randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Overall Survival at 1 Year and 2 Years | Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years. | Intent to treat population: all randomized patients. Censored patients: 31 HER2+; 19 HER2- (Taxane-); 9 HER2- (Taxane+). | Posted | Number | percentage of participants | 1 Year, 2 Years |
|
Not provided
Adverse events are provided for all patients who received at least one dose of study drug. Adverse events represent all grades (I-IV).
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 | HER2+ | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | 10 | 50 | 50 | 50 | ||
| EG001 | HER2- (Taxane-) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | 11 | 48 | 48 | 48 | ||
| EG002 | HER2- (Taxane+) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | 10 | 47 | 45 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Mucous membrane disorder | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11 | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 11 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 11 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11 | Systematic Assessment |
| |
| Alanine aminotransferase | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Haemoglobin | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Neutrophil count | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Platelet count | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| White blood cell count | Investigations | MedDRA 11 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 11 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 11 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 11 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
|---|---|
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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
| Male |
|
| 1 - Ambulatory, Restricted Strenuous Activity |
|
| 2 - Ambulatory, No Work Activities |
|
| Black |
|
| Hispanic |
|
| Other |
|
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Not Evaluable (NE) |
|
| OG002 | HER2- (Taxane+) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
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| OG002 | HER2- (Taxane+) | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
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| OG002 |
| HER2- (Taxane+) |
Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
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