Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| USOR 06-030 |
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The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Dasatinib +Fulvestrant) | Active Comparator |
| |
| Arm 2 (Fulvestrant) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets, Oral, 100 mg, once daily (QD), upto 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Disease Progression (PD) or Death | This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up. | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time of Progression-free Survival (PFS) | Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. 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. |
Not provided
For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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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 | 86336-4937 | United States | ||
| Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope |
100 participants were enrolled and 100 participants were randomized (50 to each arm). 99 were treated (50 with fulvestrant + dasatinib and 49 with single-agent fulvestrant). Reason for non-treatment is that there was 1 withdrawal by participant.
Study started September 2008 and completed January 2014; 9 participants chose to remain on active treatment after the study completed.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant and Dasatinib | Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fulvestrant | Drug | Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years |
|
|
| Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| Percentage of Participants With Progression Free Survival (PFS) at 6 Months | PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. 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. Kaplan Meier assessments were used to estimate the percentages. | at 6 months |
| Percentage of Participants With Clinical Benefit for At Least 6 Months | Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. 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. | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD) | Table represents the best response achieved over this time frame. 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. | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| Number of Participants With Best Overall Response | Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR. | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events | Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: 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. | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Florida Cancer Institute - New Hope | Hudson | Florida | 34667-6594 | United States |
| Cancer Centers Of Florida, P.A | Ocoee | Florida | 34761 | United States |
| Central Indiana Cancer Centers | Carmel | Indiana | 46032 | United States |
| Kansas City Cancer Center, Llc. | Overland Park | Kansas | 66210 | United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | United States |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | United States |
| New York Oncology Hematology, Pc | Troy | New York | 12180 | United States |
| Raleigh Hematology Oncology Associates | Raleigh | North Carolina | 27607 | United States |
| Willamette Valley Cancer Center | Eugene | Oregon | 97401 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97213 | United States |
| Texas Oncology-Central Austin Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology, P.A. | Bedford | Texas | 76022 | United States |
| Texas Oncology, P.A. | Dallas | Texas | 75230-2510 | United States |
| Texas Oncology | Dallas | Texas | 75231 | United States |
| Texas Oncology Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Cancer Center | Denton | Texas | 76210 | United States |
| El Paso Cancer Treatment Ctr - West | El Paso | Texas | 79902 | United States |
| Us Oncology Research, Inc. | Houston | Texas | 77060 | United States |
| Quest Diagnostic Clinical Laboratories Inc | Houston | Texas | 77072 | United States |
| Cancer Care Centers Of South Texas | San Antonio | Texas | 78217 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Texas Oncology Cancer Care And Research Center | Waco | Texas | 76712 | United States |
| Texas Oncology, P.A. | Webster | Texas | 77598-4420 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Oncology & Hematology Associates Of Southwest Virginia, Inc. | Salem | Virginia | 24153 | United States |
| Virginia Center Specialists, Pc | Woodbridge | Virginia | 22191 | United States |
| FG001 | Fulvestrant | Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Progression and Cross-over |
|
Intent To Treat (ITT) Population; all randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant and Dasatinib | Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years |
| BG001 | Fulvestrant | Participants in this group received a drug regimen that consisted of fulvestrant only. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 Disease Progression (PD) or Death | This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up. | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included as non-responders. Censored participants = 15 Fulvestrant and Dasatinib, 9 Fulvestrant | Posted | Number | participants | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Median Time of Progression-free Survival (PFS) | Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. 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. | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | Posted | Median | 95% Confidence Interval | months | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progression Free Survival (PFS) at 6 Months | PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. 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. Kaplan Meier assessments were used to estimate the percentages. | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | at 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit for At Least 6 Months | Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. 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 on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD) | Table represents the best response achieved over this time frame. 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. | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | Posted | Number | participants | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Best Overall Response | Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR. | Evaluable population on initial treatment with measurable lesion by RECIST (Response Evaluation Criteria In Solid Tumors). Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | Posted | Number | participants | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events | Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: 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. | Safety Population on initial treatment; any participants that was randomized to any treatment group in the study and received at least one treatment therapy. | Posted | Number | participants | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) |
|
Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
Study initiated: September 2008; Study Completion: January 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 | Fulvestrant and Dasatinib | Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years | 14 | 50 | 48 | 50 | ||
| EG001 | Fulvestrant | Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. | 11 | 49 | 44 | 49 | ||
| EG002 | Fulvestrant Crossover to Fulvestrant and Dasatinib | Arm 2b: Participants in this group started on the Fulvestrant only arm and later started receiving a drug regimen that consisted of both fulvestrant and dasatinib. These participants are all inclusive and not limited to Fulvestrant or Fulvestrant and Dasatinib treatment only. The timeframe for when these events occurred were not immediately available and may have been caused by previous exposure to Fulvestrant only (pre-crossover), therefore the events for this patient population are also reported separately. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years | 7 | 21 | 20 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Coagulation Time Increased | Cardiac disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Weakness Generalized | General disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Bowel Obstruction | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Nausea and Vomiting | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Obstruction Bowel | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pancreatitis | Hepatobiliary disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Fracture Bone | Musculoskeletal and connective tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Fracture Pathological | Musculoskeletal and connective tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Blackout Spell | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Brain metastases | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| CSF Abnormal | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Chest Pain | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Chest Pain Substernal | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pain | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Cough Productive | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Effusion Pleural | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Embolus Pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pneumonia Lobar | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pulmonary Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Stenosis Bronchial | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Thrombosis Venous Deep | Vascular disorders | MedDRA 3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Effusion Pericardial | Cardiac disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Weakness Generalized | General disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Weight Loss | General disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Hot Flashes | Endocrine disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Gastroesophageal Reflux | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Fever | Infections and infestations | MedDRA 3.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 3.0 | Systematic Assessment |
| |
| Edema | Immune system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Swelling | Immune system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| AST Increased | Metabolism and nutrition disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Joint Pain | Musculoskeletal and connective tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pain Bone | Musculoskeletal and connective tissue disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Depression | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Chest Pain | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Injection Site Pain | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Pain | Nervous system disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Common Cold | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Coughing | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Effusion Pleural | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | Systematic Assessment |
| |
| Infection Upper Respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA 3.0 | 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 |
|---|---|
| D000069439 | Dasatinib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
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Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.
Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.
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Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. |
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| OG001 | Fulvestrant | Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. |
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| OG001 | Fulvestrant | Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only. Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. |
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