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Business objectives have changed.
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
Not provided
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The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-754807 | Experimental |
| |
| BMS-754807 + letrozole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-754807 | Drug | Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Rate at 24 Weeks | Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study. | 24 weeks after initiation of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Objective Response Rate (ORR) in Participants With Measurable Disease | ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. Participants were to be evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. This outcome measure was not met due to early termination of the study |
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 |
|---|---|---|---|---|---|---|
| Univ Of Al At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Arizona |
77 participants were enrolled, 59 of whom were treated. Reasons for not entering treatment period included: 3 participants withdrew consent; 11 participants no longer met study criteria and 4 were due to other reasons.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BMS 100+LET | Treatment with 100 mg BMS-754807 + 2.5 mg letrozole |
| FG001 | BMS 100 | 100 mg BMS-754807 alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| letrozole | Drug | Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity |
|
|
| 24 weeks after initiation of study treatment |
| Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months |
| Duration of Response (DOR) in Participants With Measurable Disease | DOR was to be performed to further characterize the response rate at Week 24. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR could not be assessed due to early termination of the study. | 24 weeks after initiation of study treatment |
| Number of On-study Laboratory Abnormalities: Grade 1-2 | Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin > 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein. Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria | Assessed from day 1 up to within 30 days of last dose (Approximately 42 months) |
| Number of On-study Laboratory Abnormalities: Grade 3-4 | Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin > 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria | Assessed from day 1 up to within 30 days of last dose (Approximately 42 months) |
| Treatment Failure Rate (TFR) | The TFR was to be calculated as the total number of subjects who discontinued the treatment for any reason (including disease progression, treatment toxicity, and death) at 24 weeks divided by the total number of subjects randomized/assigned to the arm and treated. In the monotherapy arm, the TFR was to be assessed while subjects were on monotherapy. | 24 weeks after initiation of study treatment |
| Changes in Absolute Copy Numbers and Relative Expression of Insulin Receptor Isoform A (IR-A) in Tumor Tissue in Response to Treatment | Absolute copy numbers and relative expression of insulin receptor isoforms (IR-A, IR-B) in pre- and posttreatment fresh tumor tissues were to be measured. This outcome was not measured due to early termination of the study. | 24 weeks after initiation of study |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Sharp Clinical Oncology Research | San Diego | California | 92123 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| University Of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Illinois Cancercare, Pc | Peoria | Illinois | 61615 | United States |
| Indiana University Health Goshen Center For Cancer Care | Goshen | Indiana | 46526 | United States |
| Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Baltimore | Maryland | 21231-1000 | United States |
| Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Oncology Care Associates, P.A. | Wheaton | Maryland | 20902 | United States |
| Masonic Cancer Ctr, University Of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Unv. Of Nc At Chapel Hill | Chapel Hill | North Carolina | 27599-7305 | United States |
| Unv. Of Nc At Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Presbyterian Hospital Cancer Research | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center-Dept Of Medicine | Durham | North Carolina | 27710 | United States |
| Ut Md Anderson Can Ctr. | Houston | Texas | 77030-4009 | United States |
| Ut Md Anderson Can Ctr. | Houston | Texas | 77030 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| University Of Wisconsin | Madison | Wisconsin | 53792-6164 | United States |
| University Of Wisconsin | Madison | Wisconsin | 53792 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BMS 100+LET | Treatment with 100 mg BMS-754807 + 2.5 mg letrozole |
| BG001 | BMS 100 | 100 mg BMS-754807 alone |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Progression Free Survival Rate at 24 Weeks | Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study. | PFS data was not collected for any participants because the study was terminated | Posted | 24 weeks after initiation of study treatment |
|
| ||||||||||||||||||||||
| Secondary | The Objective Response Rate (ORR) in Participants With Measurable Disease | ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. Participants were to be evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. This outcome measure was not met due to early termination of the study | ORR data was not collected for any participants because the study was terminated | Posted | 24 weeks after initiation of study treatment |
|
| ||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. | All treated participants | Posted | Count of Participants | Participants | Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months |
|
| ||||||||||||||||||||
| Secondary | Duration of Response (DOR) in Participants With Measurable Disease | DOR was to be performed to further characterize the response rate at Week 24. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR could not be assessed due to early termination of the study. | DOR data was not collected for any participants because the study was terminated early | Posted | 24 weeks after initiation of study treatment |
|
| ||||||||||||||||||||||
| Secondary | Number of On-study Laboratory Abnormalities: Grade 1-2 | Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin > 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein. Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria | All treated participants | Posted | Number | Number of abnormalities | Assessed from day 1 up to within 30 days of last dose (Approximately 42 months) |
| |||||||||||||||||||||
| Secondary | Number of On-study Laboratory Abnormalities: Grade 3-4 | Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin > 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria | All treated participants | Posted | Number | Number of abnormalities | Assessed from day 1 up to within 30 days of last dose (Approximately 42 months) |
| |||||||||||||||||||||
| Secondary | Treatment Failure Rate (TFR) | The TFR was to be calculated as the total number of subjects who discontinued the treatment for any reason (including disease progression, treatment toxicity, and death) at 24 weeks divided by the total number of subjects randomized/assigned to the arm and treated. In the monotherapy arm, the TFR was to be assessed while subjects were on monotherapy. | TFR data was not collected for any participants because the study was terminated | Posted | 24 weeks after initiation of study treatment |
|
| ||||||||||||||||||||||
| Secondary | Changes in Absolute Copy Numbers and Relative Expression of Insulin Receptor Isoform A (IR-A) in Tumor Tissue in Response to Treatment | Absolute copy numbers and relative expression of insulin receptor isoforms (IR-A, IR-B) in pre- and posttreatment fresh tumor tissues were to be measured. This outcome was not measured due to early termination of the study. | Data for this Outcome Measure was not collected for any participants because the study was terminated | Posted | 24 weeks after initiation of study |
|
|
Day 1 up to within 30 days of last dose (Approximately 42 months)
AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
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 | BMS 100+LET | Treatment with 100 mg BMS-754807 + 2.5 mg letrozole | 5 | 52 | 11 | 52 | 51 | 52 |
| EG001 | BMS 100 | 100 mg BMS-754807 alone | 0 | 7 | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Glucose Tolerance Impaired | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version: 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glucose Tolerance Impaired | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Neurological Symptom | Nervous system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Mucosal Infection | Infections and infestations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Menopausal Symptoms | Reproductive system and breast disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Vulvovaginal Dryness | Reproductive system and breast disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version: 17.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version: 17.1 | 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 | Please email | 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 |
|---|---|
| C545990 | BMS 754807 |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|