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The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (ixabepilone 40 mg^2) | Experimental | ixabepilone 40 mg/m^2 every 3 weeks |
|
| Arm B (cetuximab 250 mg/m^2 + ixabepilone 40 mg/m^2) | Experimental | cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ixabepilone | Drug | injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first. Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST]) | The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method. | Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks) |
| Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST) | PD = At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. | Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time interval from date of randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Graz | 8036 | Austria | |||
| Local Institution |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone 40 mg/m^2 | ixabepilone 40 mg/m^2 every 3 weeks |
| FG001 | Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2 | cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| ixabepilone + cetuximab | Drug | Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first. Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria. Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first. Cetuximab 400 mg/m^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria. |
|
|
| From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months) |
| Time to Response | Time to response is defined as the time from the date of start of treatment until measurement criteria are first met for PR or CR (whichever is recorded first). CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions with reference to the baseline sum LD. Time to response was estimated using the Kaplan-Meier product-limit method. | Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.) |
| Duration of Response | Defined as period from the time that measurement criteria are first met for CR or PR until first date of documented PD or death. Estimated using the Kaplan-Meier product-limit method; CI was computed using Brookmeyer and Crowley method. CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of LD of all target lesions with reference to baseline sum LD. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. | From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 months) |
| Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. Other reasons for death included hepatic failure and respiratory distress. | Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm) |
| Number of Participants With Hematology Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Hemoglobin:GR1=\ | Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm) |
| Number of Participants With Serum Chemistry Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase: GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. | Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm) |
| Vienna |
| 1090 |
| Austria |
| Local Institution | Brno | 656 53 | Czechia |
| Local Institution | Prague | 128 08 | Czechia |
| Local Institution | Prague | 150 06 | Czechia |
| Local Institution | Bayonne | 64100 | France |
| Local Institution | Dijon | 21079 | France |
| Local Institution | Lyon | 69008 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Saint-Brieuc | 22015 | France |
| Local Institution | Saint-Herblain | 44805 | France |
| Local Institution | Toulouse | 31052 | France |
| Local Institution | Thessaloniki | 54642 | Greece |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Gdansk | 80952 | Poland |
| Local Institution | Olsztyn | 10-513 | Poland |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Barcelona | 08208 | Spain |
| Local Institution | Barcelona | 08221 | Spain |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixabepilone 40 mg/m^2 | ixabepilone 40 mg/m^2 every 3 weeks |
| BG001 | Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2 | cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks |
| 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 | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Karnofsky Performance Status | Karnofsky Performance Status classifies patients according to their functional impairment. Scores range from 0-100 units on a scale, the lower the score, the worse the survival for most serious illnesses. 100: Normal, no complaints; 90: Able to carry on normal activities; minor signs or symptoms of disease; 80: Normal activity with effort; some signs or symptoms of disease. | Number | participants |
| |||||||||||||||
| Setting of Prior Chemotherapy | Participants may have received chemotherapy in more than one setting. | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time interval from date of randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. | All randomized participants. Participants who did not progress or die were censored on the date of their last tumor assessment. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to response is defined as the time from the date of start of treatment until measurement criteria are first met for PR or CR (whichever is recorded first). CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions with reference to the baseline sum LD. Time to response was estimated using the Kaplan-Meier product-limit method. | Randomized participants with response of CR or PR. | Posted | Median | Full Range | weeks | Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.) |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST]) | The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method. | All randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response | Defined as period from the time that measurement criteria are first met for CR or PR until first date of documented PD or death. Estimated using the Kaplan-Meier product-limit method; CI was computed using Brookmeyer and Crowley method. CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of LD of all target lesions with reference to baseline sum LD. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. | Randomized participants with response of CR or PR. Participants who did not relapse or die were censored on the date of their last tumor assessment. | Posted | Median | 95% Confidence Interval | months | From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. Other reasons for death included hepatic failure and respiratory distress. | All treated participants: Participants who received any treatment (ixabepilone or cetuximab). | Posted | Number | participants | Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematology Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Hemoglobin:GR1=\ | Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time. | Posted | Number | participants | Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST) | PD = At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. | All randomized participants. | Posted | Number | participants | Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months). |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serum Chemistry Abnormalities | Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase: GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. | Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time. | Posted | Number | participants | Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm) |
|
Assessed from the date of first dose until at least 30 days after the last dose of study drug (Median number of ixabepilone cycles were 5 [range: 1-18 cycles for ixabepilone arm; 1-12 cycles for cetuximab + ixabepilone arm])
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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 | Ixabepilone 40 mg/m^2 | ixabepilone 40 mg/m^2 every 3 weeks | 9 | 40 | 40 | 40 | ||
| EG001 | Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2 | cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks | 12 | 37 | 37 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| INFLAMMATION | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| SINUS ARRHYTHMIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SUBCLAVIAN VEIN THROMBOSIS | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NEUROTOXICITY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | 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 | |
|---|---|---|---|---|
| BMS 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 |
|---|---|
| C430592 | ixabepilone |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 |
|
| Black/African American |
|
| 90 |
|
| 80 |
|
| Not Reported |
|
| Neo-adjuvant therapy |
|
| Adjuvant and Neo-adjuvant |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|