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| ID | Type | Description | Link |
|---|---|---|---|
| B1871010 | Other Identifier | Alias Study Number | |
| 2008-006252-21 | EudraCT Number |
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See termination reason in detailed description.
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This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.
This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Combination of Bosutinib and Letrozole |
|
| 2 | Active Comparator | Letrozole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib | Drug | 400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Based on Independent Radiologist | Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PFS assessed by independent radiologist was to be reported. | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Institute of Research | Whittier | California | 90603 | United States | ||
| Joliet Oncology Hematology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24674874 | Derived | Moy B, Neven P, Lebrun F, Bellet M, Xu B, Sarosiek T, Chow L, Goss P, Zacharchuk C, Leip E, Turnbull K, Bardy-Bouxin N, Duvillie L, Lang I. Bosutinib in combination with the aromatase inhibitor letrozole: a phase II trial in postmenopausal women evaluating first-line endocrine therapy in locally advanced or metastatic hormone receptor-positive/HER2-negative breast cancer. Oncologist. 2014 Apr;19(4):348-9. doi: 10.1634/theoncologist.2014-0021. Epub 2014 Mar 27. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Study was pre-maturely terminated after part 1 (safety lead-in phase) of the study and hence, the planned treatments of part 2, bosutinib + letrozole (Part 2) and letrozole (Part 2), were not administered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bosutinib + Letrozole (Part 1) | Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Letrozole | Drug | 2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs |
|
| Letrozole | Drug | 2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs |
|
| Part 1 Baseline up to 28 days after the last dose |
| Progression-Free Survival (PFS) Based on Investigator | Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was "Death"). PFS assessed by investigator was to be reported. | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
| Percentage of Participants With Objective Response | Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
| Overall Survival (OS) | Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Part 2 Baseline until death or up to 36 months |
| Duration of Response (DR) | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
| Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) | FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. | Part 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose |
| Maximum Observed Plasma Concentration (Cmax) | 0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | 0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29 |
| Joliet |
| Illinois |
| 60435 |
| United States |
| Oncology Specialists SC | Niles | Illinois | 60714 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 84202 | United States |
| AZ Sint-Augustinus | Wilrijk | 2610 | Belgium |
| Cancer Hospital, Academy of Med Science and Peking Union Med | Beijing | Beijing Municipality | 100021 | China |
| UNIMED Medical Institute | Hong Kong | Hong Kong |
| Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly | Budapest | 1122 | Hungary |
| Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdr | Warsaw | 04125 | Poland |
| Johns Hopkins Singapore International Medical Centre | Singapore | 308433 | Singapore |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bosutinib + Letrozole (Part 1) | Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred. |
| 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 |
|
| 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 (PFS) Based on Independent Radiologist | Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PFS assessed by independent radiologist was to be reported. | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all participants who receive at least 1 dose of study treatment. | Posted | Number | percentage of participants | Part 1 Baseline up to 28 days after the last dose |
|
| ||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Based on Investigator | Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was "Death"). PFS assessed by investigator was to be reported. | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response | Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
| |||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | Part 2 Baseline until death or up to 36 months |
|
| ||||||||||||||||||||||
| Secondary | Duration of Response (DR) | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose |
|
| ||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) | FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | Part 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose |
| |||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | 0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29 |
|
| |||||||||||||||||||||||
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | 0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29 |
|
| |||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment. | Posted | 0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29 |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bosutinib + Letrozole (Part 1) | Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred. | 5 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Post procedural diarrhoea | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine | Investigations | MedDRA | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Results are not provided because the study was terminated prior to part 2 due to unfavorable risk benefit ratio of the study treatment.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.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 |
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| ID | Term |
|---|---|
| C471992 | bosutinib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Units | Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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