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| ID | Type | Description | Link |
|---|---|---|---|
| USOR 06-185 |
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| Name | Class |
|---|---|
| US Oncology Research | INDUSTRY |
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The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets, Oral, 100 mg once daily, up to 2 years |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population | CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome. | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Arizona Hematology & Oncology Associates | Sedona | Arizona | 86336 | United States | ||
| Arizona Oncology Associates D.B.A. Hematology Oncology |
120 participants were enrolled, randomized and treated.
Study started October 2008 and completed June 2014; 23 participants chose to remain on active treatment after the study completed.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib Plus Letrozole | Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years Dasatinib 100 mg + Letrozole 2.5 mg Tablets, once daily up to 2 years. If a participant experienced intolerable toxicity related to dasatinib, they had the option to crossover to letrozole arm. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Letrozole | Drug | Tablets, Oral, 2.5 mg, once daily, up to 2 years |
|
|
| First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
| Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population | PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014. | Day 1 to Study Completion (approximately 6 years) |
| Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib | Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
| Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population | Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants. | At 6 months and at 12 months |
| Median Time to Treatment Failure (TTF) - ITT Population | Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen. | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years) |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80220 | United States |
| Florida Cancer Institute - New Hope | Hudson | Florida | 34667 | United States |
| Central Indiana Cancer Centers | Carmel | Indiana | 46032 | United States |
| New York Oncology Hematology, Pc | Troy | New York | 12180 | United States |
| Dayton Oncology And Hematology | Kettering | Ohio | 45409 | United States |
| Willamette Valley Cancer Center | Eugene | Oregon | 97401 | United States |
| Northwest Cancer Specialists, Pc | Portland | Oregon | 97213 | United States |
| Medical Oncology Associates | Kingston | Pennsylvania | 18704 | United States |
| Texas Oncology-Central Austin Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology | Bedord | Texas | 76022 | United States |
| Texas Cancer Center At Medical City | Dallas | Texas | 75230 | United States |
| Texas Oncology | Dallas | Texas | 75231 | United States |
| Texas Oncology Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| El Paso Cancer Treatment Ctr - East | El Paso | Texas | 79915 | United States |
| Texas Oncology | Fort Worth | Texas | 76104 | United States |
| Texas Oncology | Garland | Texas | 75042 | United States |
| Texas Oncology | Houston | Texas | 77024 | United States |
| Texas Oncology-Plano East | Plano | Texas | 75075 | United States |
| Cancer Care Centers Of South Texas | San Antonio | Texas | 78217 | United States |
| Texas Oncology Cancer Center - Sugar Land | Sugar Land | Texas | 77479 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Texas Oncology Cancer Care And Research Center | Waco | Texas | 76712 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Oncology & Hematology Associates Of Southwest Virginia, Inc. | Salem | Virginia | 24153 | United States |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | United States |
| Letrozole |
Participants received letrozole 2.5 mg tablets, once daily, up to 2 years. If the participant developed progressive disease while on the single agent, the participant had the option to add dasatinib to their treatment regimen. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib Plus Letrozole | Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years Dasatinib 100 mg + Letrozole 2.5 mg |
| BG001 | Letrozole | Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years |
| 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, Customized | Number | participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population | CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome. | Evaluable Population was defined as all treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of randomized study drug. Participants presented in the treatment arm to which they were originally randomized. | Posted | Number | participants | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | All treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of study drug were analyzed. The participants are analyzed as per the treatment arm to which they were originally randomized. | Posted | Number | participants | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population | PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014. | ITT population includes all participants enrolled in the study. The participants were analyzed as per the treatment arm to which they were originally randomized. | Posted | Median | 95% Confidence Interval | months | Day 1 to Study Completion (approximately 6 years) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib | Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Participants who changed their treatment regimen from single-agent letrozole to letrozole + dasatinib during the study. | Posted | Number | 95% Confidence Interval | percentage of participants | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population | Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants. | ITT population=Includes all participants registered on the study. n= number at risk | Posted | Number | 95% Confidence Interval | percentage of participants | At 6 months and at 12 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Time to Treatment Failure (TTF) - ITT Population | Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen. | ITT population: All participants enrolled in the study. | Posted | Median | 95% Confidence Interval | Months | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | All participants who received at least one dose of study drug were summarized. The participants were analyzed as per the treatment arm to which they were originally randomized. | Posted | Number | participants | First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years) |
|
First dose of study drug to last dose plus 30 days
Study initiated 2008 and completed 2014.
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 | Dasatinib Plus Letrozole | Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years Dasatinib 100 mg + Letrozole 2.5 mg | 14 | 57 | 56 | 57 | ||
| EG001 | Letrozole | Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years | 2 | 63 | 57 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity Reaction | Immune system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cardiac Insufficiency | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Congestive Heart Failure | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Coronary Insufficiency | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Effusion Pericardial | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| CVA | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea and Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fever | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Failure Liver | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fracture Bone | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Body Numbness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Discomfort Abdominal | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Mood Altered | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Disease Heart Pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Effusion Pleural | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Disease Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cerebral Infarction | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Failure Heart | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Allergy | Immune system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ALT Increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ankles Swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Anxiety | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Appetite Decreased | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| AST Increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blisters | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Breath Shortness | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Common cold | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Coughing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Creatinine Serum increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Depression | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dryness Vaginal | Reproductive system and breast disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroesophageal reflux | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Effusion Pericardial | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Weight Loss | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Flash Hot | Endocrine disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hot Flashes | Endocrine disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fever | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Edema | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Edema Periorbital | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Swelling | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fluid Retention in Tissues | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fracture Bone | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Joint Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Knee Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain Flank | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain Knee | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain Neck | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain Pelvic | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Taste Alteration | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Effusion Pleural | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Infection Respiratory | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Infection Upper Respiratory | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Flu-like Symptoms | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.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 |
|---|---|
| D000069439 | Dasatinib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D009570 | Nitriles |
| D014230 | Triazoles |
Not provided
Not provided
|
| Male |
|
| CBR, DFI > 2 Years |
|
Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days |
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