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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-MC-S329 | Other Identifier | Eli Lilly and Company |
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Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine+Doxorubicin+Cisplatin+Surgery | Experimental | Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Pathological Complete Response (Pathological Complete Response Rate) | Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified. | tumor assessment at baseline and during surgery after eight 21-day treatment cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Deaths During Study | baseline through last cycle on study drug (eight 21-day cycles) | |
| Progression Free Survival (PFS) | PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints. |
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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 clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician. | Pune | Maharashtra | 411001 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine+Doxorubicin+Cisplatin+Surgery | Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine+Doxorubicin+Cisplatin+Surgery | Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 | Number of Patients With Pathological Complete Response (Pathological Complete Response Rate) | Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified. | Intent to treat population. | Posted | Number | participants | tumor assessment at baseline and during surgery after eight 21-day treatment cycles |
|
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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+Doxorubicin+Cisplatin+Surgery | Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 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 |
| D004317 | Doxorubicin |
| D002945 | Cisplatin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| doxorubicin | Drug | 60 mg/m^2, IV, every 21 days x 4 cycles (1-4) |
|
| cisplatin | Drug | 70 mg/m^2, IV, every 21 days x 4 cycles (5-8) |
|
| surgery | Procedure | Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
|
| baseline to measured progressive disease or death from any cause (up to 68 months) |
| Overall Survival | Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints. | baseline to date of death from any cause up to 68 months |
| Time to Treatment Failure | Time to treatment failure was 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. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints. | baseline to stopping treatment (up to 68 months) |
| Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery | The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery. | baseline, after eight 21-day cycles of study drug |
| India |
| For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician. | Vellore | Tamil Nadu | 632004 | India |
| For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician. | Delhi | 110029 | India |
| Withdrawal by Subject |
|
| Death - Possibly Study Drug Related |
|
| Progressive Disease/Lack of Efficacy |
|
| Death - Not Study-Drug Related |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Number | participants |
|
| Disease Stage | Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIA-cancer cells found in lymph nodes, or tumor is larger than 2 cm, but less than 5 cm and not in lymph nodes; Stage IIB - tumor larger than 2 cm, but less than 5 cm and in lymph nodes, or tumor larger than 5 cm but not in lymph nodes; Stage IIIA - cancer has spread to nearby tissues; Stage IIIB - cancer has spread to chestwall and/or skin, and lymph nodes near breastbone. | Number | participants |
|
| Hormone Receptor Status | Status of the estrogen receptors (ER) and progesterone receptors (PR). A score of Estrogen Receptor positive (ER+) means that estrogen is causing the tumor to grow and Progesterone Receptor positive (PR+) means that progesterone is causing the tumor to grow. | Number | participants |
|
| Human Epidermal Growth Factor Receptor 2 (HER-2) Status | Status determines if there is too much HER-2 receptor protein on the surface of the breast cancer cell. Results range from 0 (negative), 1+ (negative), 2+ (borderline) to 3+ (positive). | Number | participants |
|
| Karnofsky Performance Status Scale | Classifies patients according to their functional impairment. Scores range from 0-100 (in increments of 10), the lower the score, the worse the survival for most serious illnesses. | Number | participants |
|
| Menopausal Status | Number | participants |
|
| Body Surface Area | The calculation is from the formula of DuBois and DuBois: BSA = (Weight^0.425 x Height^0.725) x 0.007184, where weight is in kilograms and height is in centimeters. | Median | Full Range | meters squared (m^2) |
|
| Height | Median | Full Range | centimeters (cm) |
|
| Largest Lesion Size | Median | Full Range | millimeters (mm) |
|
| Weight | Median | Full Range | kilograms (kg) |
|
Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
|
| Secondary | Summary of Deaths During Study | Intent to treat population. | Posted | Number | participants | baseline through last cycle on study drug (eight 21-day cycles) |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints. | Median was not reached. | Posted | Median | 95% Confidence Interval | months | baseline to measured progressive disease or death from any cause (up to 68 months) |
|
|
| Secondary | Overall Survival | Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints. | Median was not reached | Posted | Median | 95% Confidence Interval | months | baseline to date of death from any cause up to 68 months |
|
|
| Secondary | Time to Treatment Failure | Time to treatment failure was 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. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints. | Upper limit of 95% Confidence Interval of median survival was not calculable. | Posted | Median | 95% Confidence Interval | weeks | baseline to stopping treatment (up to 68 months) |
|
|
| Secondary | Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery | The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery. | Posted | Number | participiants | baseline, after eight 21-day cycles of study drug |
|
|
|
| Post-Hoc | Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study | The cumulative number of participants with an event (either progressive disease or death) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without progressive disease or still alive at the beginning of each time point. | Intent to treat population. | Posted | Number | participants | baseline up to 68 months |
|
|
|
| Post-Hoc | Number of Participants Who Died From Any Cause at Various Time Points | The cumulative number of participants with an event (death from any cause) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants still alive at the beginning of each time point. | Intent to treat population. | Posted | Number | participants | baseline up to 68 months |
|
|
|
| Post-Hoc | Number of Participants With Time to Treatment Failure at Various Time Points | This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point. | Intent to treat population. | Posted | Number | participants | baseline to stopping treatment (up to 68 months) |
|
|
|
| 17 |
| 65 |
| 64 |
| 65 |
| Neutropenia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedRA 12.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedRA 12.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedRA 12.1 | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedRA 12.1 | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedRA 12.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedRA 12.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedRA 12.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedRA 12.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedRA 12.1 | Systematic Assessment |
|
| Incorrect dose administered | Injury, poisoning and procedural complications | MedRA 12.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedRA 12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedRA 12.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedRA 12.1 | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedRA 12.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedRA 12.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedRA 12.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedRA 12.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedRA 12.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedRA 12.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedRA 12.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedRA 12.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedRA 12.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedRA 12.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedRA 12.1 | Systematic Assessment |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Title | Measurements |
|---|---|
|
| Study Drug Toxicity: Neutropenic sepsis |
|
| Myocardial infarction |
|
| Title | Measurements |
|---|---|
|
| 6 Months: Number of Patients at Risk |
|
| 12 Months: Number of Patients with Event |
|
| 12 Months: Number of Patients at Risk |
|
| 24 Months: Number of Patients with Event |
|
| 24 Months: Number of Patients at Risk |
|
| 48 Months: Number of Patients with Event |
|
| 48 Months: Number of Patients at Risk |
|
| 68 Months: Number of Patients with Event |
|
| 68 Months: Number of Patients at Risk |
|
| Title | Measurements |
|---|---|
|
| 6 Months: Number of Patients at Risk |
|
| 12 Months: Number of Patients With Event |
|
| 12 Months: Number of Patients at Risk |
|
| 26 Months: Number of Patients With Event |
|
| 26 Months: Number of Patients at Risk |
|
| 48 Months: Number of Patients With Event |
|
| 48 Months: Number of Patients at Risk |
|
| 68 Months: Number of Patients With Event |
|
| 68 Months: Number of Patients at Risk |
|
| Title | Measurements |
|---|---|
|
| 6 Months: Number of Patients at Risk |
|
| 12 Months: Number of Patients with Event |
|
| 12 Months: Number of Patients at Risk |
|
| 24 Months: Number of Patients with Event |
|
| 24 Months: Number of Patients at Risk |
|
| 48 Months: Number of Patients with Event |
|
| 48 Months: Number of Patients at Risk |
|
| 68 Months: Number of Patients with Event |
|
| 68 Months: Number of Patients at Risk |
|