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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-VI-S326 |
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The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Cisplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. | baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
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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 9AM - 5PM 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 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician | Munich | 81377 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine + Cisplatin | Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle). Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine + Cisplatin | Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle). Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Objective Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. | Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease. | Posted | Number | participants | baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine + Cisplatin | Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle). Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| cisplatin | Drug | Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle). |
|
| Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. | first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
| Time to Treatment Failure | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. | first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
| Survival Time | Overall survival is the duration from enrollment to death due to any cause. | first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
| Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). | Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) |
| Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death). | Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) |
| Number of Deaths | Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
| Number of Participants With Adverse Events Leading to Discontinuation | Baseline through eight 21-day cycles |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician | Moscow | 115478 | Russia |
| Protocol Violation |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Menopausal Status | Number | participants |
|
| Pathological Diagnosis | Number | participants |
|
| Stage of Disease at Entry to the Study | Stage of disease was determined using American Joint Committee on Cancer Staging Criteria for Breast Cancer. The higher the stage, the more severe the disease. | Number | participants |
|
| Stage of Disease at Time of Diagnosis | Stage of disease was determined using American Joint Committee on Cancer Staging Criteria for Breast Cancer. The higher the stage, the more severe the disease. | Number | participants |
|
| Time from Initial Diagnosis to Study Entry | Mean | Standard Deviation | month |
|
|
|
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | Response population: all enrolled participants who had either a complete or partial response. | Posted | Median | 95% Confidence Interval | weeks | first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
|
|
|
| Secondary | Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. | Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease. | Posted | Median | 95% Confidence Interval | weeks | first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
|
|
|
| Secondary | Time to Treatment Failure | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. | Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease. | Posted | Median | 95% Confidence Interval | weeks | first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
|
|
|
| Secondary | Survival Time | Overall survival is the duration from enrollment to death due to any cause. | Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease. | Posted | Median | 95% Confidence Interval | weeks | first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
|
|
|
| Secondary | Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination | The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). | Safety Population: all enrolled participants who received study drug. | Posted | Number | participants | Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) |
|
|
|
| Secondary | Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades | Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death). | Safety Population: all enrolled participants who received study drug. | Posted | Number | participants | Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) |
|
|
|
| Secondary | Number of Deaths | All enrolled participants. | Posted | Number | participants | Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) |
|
|
|
| Secondary | Number of Participants With Adverse Events Leading to Discontinuation | Safety Population: all enrolled participants who received study drug. | Posted | Number | participants | Baseline through eight 21-day cycles |
|
|
|
| 6 |
| 54 |
| Ventricular fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Periproctitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Title | Measurements |
|---|---|
|
| Allergic reaction/hypersensivity - Grade 4 |
|
| Allergic rhinitis - Grade 1 |
|
| Allergic rhinitis - Grade 2 |
|
| Allergic rhinitis - Grade 3 |
|
| Allergic rhinitis - Grade 4 |
|
| Other auditory/hearing - Grade 1 |
|
| Other auditory/hearing - Grade 2 |
|
| Other auditory/hearing - Grade 3 |
|
| Other auditory/hearing - Grade 4 |
|
| Blood/Bone marrow - other - Grade 1 |
|
| Blood/Bone marrow - other - Grade 2 |
|
| Blood/Bone marrow - other - Grade 3 |
|
| Blood/Bone marrow - other - Grade 4 |
|
| Cardiac- ischemia/infarction - Grade 1 |
|
| Cardiac- ischemia/infarction - Grade 2 |
|
| Cardiac- ischemia/infarction - Grade 3 |
|
| Cardiac- ischemia/infarction - Grade 4 |
|
| Hypertension - Grade 1 |
|
| Hypertension - Grade 2 |
|
| Hypertension - Grade 3 |
|
| Hypertension - Grade 4 |
|
| Hypotension - Grade 1 |
|
| Hypotension - Grade 2 |
|
| Hypotension - Grade 3 |
|
| Hypotension - Grade 4 |
|
| Fatigue - Grade 1 |
|
| Fatigue - Grade 2 |
|
| Fatigue - Grade 3 |
|
| Fatigue - Grade 4 |
|
| Fever - Grade 1 |
|
| Fever - Grade 2 |
|
| Fever - Grade 3 |
|
| Fever - Grade 4 |
|
| Rigors, chills - Grade 1 |
|
| Rigors, chills - Grade 2 |
|
| Rigors, chills - Grade 3 |
|
| Rigors, chills - Grade 4 |
|
| Weight loss - Grade 1 |
|
| Weight loss - Grade 2 |
|
| Weight loss - Grade 3 |
|
| Weight loss - Grade 4 |
|
| Alopecia - Grade 1 |
|
| Alopecia - Grade 2 |
|
| Alopecia - Grade 3 |
|
| Alopecia - Grade 4 |
|
| Rash/desquamation - Grade 1 |
|
| Rash/desquamation - Grade 2 |
|
| Rash/desquamation - Grade 3 |
|
| Rash/desquamation - Grade 4 |
|
| Anorexia - Grade 1 |
|
| Anorexia - Grade 2 |
|
| Anorexia - Grade 3 |
|
| Anorexia - Grade 4 |
|
| Constipation - Grade 1 |
|
| Constipation - Grade 2 |
|
| Constipation - Grade 3 |
|
| Constipation - Grade 4 |
|
| Mucositis due to radiation - Grade 1 |
|
| Mucositis due to radiation - Grade 2 |
|
| Mucositis due to radiation - Grade 3 |
|
| Mucositis due to radiation - Grade 4 |
|
| Nausea - Grade 1 |
|
| Nausea - Grade 2 |
|
| Nausea - Grade 3 |
|
| Nausea - Grade 4 |
|
| Vomiting - Grade 1 |
|
| Vomiting - Grade 2 |
|
| Vomiting - Grade 3 |
|
| Vomiting - Grade 4 |
|
| SGPT (ALT) - Grade 1 |
|
| SGPT (ALT) - Grade 2 |
|
| SGPT (ALT) - Grade 3 |
|
| SGPT (ALT) - Grade 4 |
|
| Infection without neutropenia - Grade 1 |
|
| Infection without neutropenia - Grade 2 |
|
| Infection without neutropenia - Grade 3 |
|
| Infection without neutropenia - Grade 4 |
|
| Insomnia - Grade 1 |
|
| Insomnia - Grade 2 |
|
| Insomnia - Grade 3 |
|
| Insomnia - Grade 4 |
|
| Abdominal pain or cramping - Grade 1 |
|
| Abdominal pain or cramping - Grade 2 |
|
| Abdominal pain or cramping - Grade 3 |
|
| Abdominal pain or cramping - Grade 4 |
|
| Headache - Grade 1 |
|
| Headache - Grade 2 |
|
| Headache - Grade 3 |
|
| Headache - Grade 4 |
|
| Pain - Other - Grade 1 |
|
| Pain - Other - Grade 2 |
|
| Pain - Other - Grade 3 |
|
| Pain - Other - Grade 4 |
|
| Renal/Genitourinary - Other - Grade 1 |
|
| Renal/Genitourinary - Other - Grade 2 |
|
| Renal/Genitourinary - Other - Grade 3 |
|
| Renal/Genitourinary - Other - Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Hemoglobin (g/L) - Grade 4 |
|
| Neutrophils (x10E9/L) - Grade 1 |
|
| Neutrophils (x10E9/L) - Grade 2 |
|
| Neutrophils (x10E9/L) - Grade 3 |
|
| Neutrophils (x10E9/L) - Grade 4 |
|
| Platelets (x10E9/L) - Grade 1 |
|
| Platelets (x10E9/L) - Grade 2 |
|
| Platelets (x10E9/L) - Grade 3 |
|
| Platelets (x10E9/L) - Grade 4 |
|
| White Blood Cells (x10E9/L) - Grade 1 |
|
| White Blood Cells (x10E9/L) - Grade 2 |
|
| White Blood Cells (x10E9/L) - Grade 3 |
|
| White Blood Cells (x10E9/L) - Grade 4 |
|
| Measurements |
|---|
|
| Title |
|---|
| Measurements |
|---|
|