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This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin-bound paclitaxel, Carboplatin + Herceptin | Experimental | Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin-bound paclitaxel | Drug | Administered by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response | Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits. | Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Total Response | Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Seidman, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breastlink Med Group | Long Beach | California | 90806 | United States | ||
| Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20705560 | Result | Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036. |
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Due to slow patient accrual, only 32 patients of the planned 50 patients were enrolled. Patients were enrolled between June 2004 and July 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Albumin-bound Paclitaxel, Carboplatin + Herceptin | Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Carboplatin | Drug | Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity. |
|
|
| Herceptin® | Drug | Administered by IV infusion |
|
|
| Evaluated every 2 cycles, up to a maximum of 39 cycles. |
| Time to Disease Progression | Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods. | Assessed every 2 cycles, up to a maximum of 39 cycles. |
| Duration of Response | Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. | Assessed every 2 cycles, up to a maximum of 39 cycles. |
| Overall Patient Survival | Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods. | From Day 1 until approximately 44 months. |
| Number of Participants With Adverse Events (AEs) | A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above | Day 1 up to 39 cycles |
| Stamford |
| Connecticut |
| 06902 |
| United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Lombardi Cancer Center Georgetown University Hospital | Washington D.C. | District of Columbia | 2007 | United States |
| Florida Cancer Institute | Hudson | Florida | 34667 | United States |
| Gulf Coast Oncology Associates | St. Petersburg | Florida | 33705 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Gerogia Cancer Specialist | Atlanta | Georgia | 30341 | United States |
| Maine Center for Cancer Medicine and Blood Disorders | Scarborough | Maine | 04074 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| University of Pittsburgh Medical Center Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Southwest Regional Cancer Center | Austin | Texas | 78705 | United States |
| Swedish Medical Center Cancer Institute Research | Seattle | Washington | 98104 | United States |
| At Least One Response Assessment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Albumin-bound Paclitaxel, Carboplatin + Herceptin | Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment. |
| 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 | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Menopausal Status | Number | participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale used to assess the progress of disease, how the disease affects the daily living abilities of the patient, and to determine appropriate treatment and prognosis. 0=Fully active, able to perform all pre-disease activity. 1=Restricted in physically strenuous activity, ambulatory, able to perform light work. 2=Ambulatory, capable of all selfcare, unable to carry out any work activities. Up and about >50% of waking hours. 3=Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4=Completely disabled. Cannot perform any selfcare. Confined to bed or chair. 5=Dead. | Number | participants |
| ||||||||||||||||||||||
| Physician assessment of peripheral neuropathy | The physician assessed sensory neuropathy using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) of "Neurology -- Neuropathy - Sensory". The scale is 0=normal and 1=asymptomatic; loss of deep tendon reflexes or paresthesia (including tingling) but not interfering with function. Data available for 31 participants. | Number | participants |
| ||||||||||||||||||||||
| Histology of Primary Diagnosis | Number | participants |
| |||||||||||||||||||||||
| Time from first documented metastatic disease to study entry | Median | Full Range | years |
| ||||||||||||||||||||||
| Specific site(s) of metastasis/relapse | Participants can be in multiple sites of metastasis/relapse categories. | Number | participants |
| ||||||||||||||||||||||
| Dominant site of metastasis/relapse | Number | participants |
| |||||||||||||||||||||||
| Number of Lesions (Target + Non-Target) | Number | participants |
| |||||||||||||||||||||||
| Dominant Lesion Site (Target + Non-Target) | 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 | Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response | Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits. | The treated population consisted of all randomized participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Total Response | Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. | Treated population | Posted | Number | 95% Confidence Interval | percentage of participants | Evaluated every 2 cycles, up to a maximum of 39 cycles. |
| |||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods. | Treated population | Posted | Median | 95% Confidence Interval | months | Assessed every 2 cycles, up to a maximum of 39 cycles. |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. | Treated Population - Patients with a Confirmed Complete or Partial Overall Response | Posted | Median | 95% Confidence Interval | months | Assessed every 2 cycles, up to a maximum of 39 cycles. |
| |||||||||||||||||||||||||||
| Secondary | Overall Patient Survival | Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods. | Treated population | Posted | Median | 95% Confidence Interval | months | From Day 1 until approximately 44 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above | Treated population | Posted | Number | participants | Day 1 up to 39 cycles |
|
Day 1 up to 39 months
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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 | Albumin-bound Paclitaxel, Carboplatin + Herceptin | Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment. | 5 | 32 | 32 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rigors | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Facial pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| White blood cell count | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Blood creatinine abnormal | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
|
Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Sponsor a copy of the manuscript at least 30 days prior to submission; if no response is received within 30 days the publication or presentation may proceed without delay. Sponsor may request that Confidential Information be deleted. Publication may be delayed for an additional 60 days if patentable matter is included.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.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 |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| White, Hispanic or Latino |
|
| Title | Measurements |
|---|---|
|
| 2 (Ambulatory, but Unable to Work) |
|
|
| Lymph Nodes |
|
| Lung |
|
| Liver |
|
| Peritoneal |
|
| Bone |
|
| Other |
|
| > 3 lesions |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
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