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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000709-12 | EudraCT Number |
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To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Experimental | Participants will receive MCH (liposomal doxorubicin hydrochloride [60 milligrams {mg}/square meter {m^2}], cyclophosphamide (600 mg/m^2), and trastuzumab (8 or 6 mg/kilogram {kg}), administered as intravenous (IV) infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. After 4 cycles of MCH, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [6 mg/kg]). |
|
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Active Comparator | Participants will receive AC (free doxorubicin hydrochloride [60 mg/m^2] and cyclophosphamide [600 mg/m^2]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [8 or 6 mg/kg]). For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal doxorubicin hydrochloride | Drug | Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast | The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue . | At the end of Cycle 8 (each cycle length = 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines | CR: Disappearance of the lesions and no new lesions. In case of bone metastasis a CR is represented by the normalization of radiography or the complete sclerotic healing of lytic area. PR: In the case of bidimensionally measurable lesions/tumors, a decrease by at least 50% of the sum of the products of the largest perpendicular diameters of each individual lesion/tumor. In the case of unidimensionally measurable lesions a decrease by at least 50% in the largest linear tumour measurement. In the case of non-measurable but evaluable lesions an appreciable change of lesions referable to disease improvement. For bone lesions partial decrease in size or recalcification of lytic areas. No lesion should have progressed and no new lesion should appear. |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
The participant:
Note: Other inclusion and exclusion criteria may apply.
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 16 | Kufstein | Austria | ||||
| Teva Investigational Site 15 |
Participants were randomly assigned in 1:1 ratio to investigational group (Doxorubicin [MYOCET] + Cyclophosphamide + Trastuzumab [MCH] and Docetaxel + Trastuzumab [TH]) and comparison group (Doxorubicin [Anthracycline] + Cyclophosphamide [AC] and Docetaxel + Trastuzumab [TH]).
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Participants received MCH (liposomal doxorubicin hydrochloride [60 milligrams {mg}/square meter {m^2}], cyclophosphamide (600 mg/m^2), and trastuzumab (8 or 6 mg/kilogram {kg}), administered as intravenous (IV) infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. After 4 cycles of MCH, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [6 mg/kg]). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cyclophosphamide | Drug | Cyclophosphamide will be administered per dose and schedule specified in the arm description. |
|
| Trastuzumab | Drug | Trastuzumab will be administered per dose and schedule specified in the arm description. |
|
| Free doxorubicin hydrochloride | Drug | Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. |
|
|
| Docetaxel | Drug | Docetaxel will be administered per dose and schedule specified in the arm description. |
|
| At the end of Cycle 8 (each cycle length = 21 days) |
| Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF) | Occurrence of Class III or IV (NYHA) CHF has been reported. Class III: Participants with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | Baseline up to the end of Cycle 8 (each cycle length = 21 days) |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). LVEF was measured using multigated acquisition (MUGA) or echocardiography. | Baseline, up to 5 years |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. AEs included both SAEs and non-serious AEs. The TEAE was an AE that began or worsened after treatment with study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | Baseline up to the end of Cycle 8 (cycle length = 21 days) |
| Percentage of Participants With Progression or Death | Progression was defined as a 25% or more increase in the size of the lesion or appearance of new lesion. If the participant did not develop an event (disease progression or death), the participant was censored at the last known tumor assessment date (or last follow-up visit without progression documented). | Up to 5 Years after randomization |
| Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node | The pCR of breast and node was based upon histologic examination, as confirmed by a central panel of experts, of breast tissue resected. | At the end of Cycle 8 (each cycle length = 21 days) |
| Number of Participants Undergoing Breast Conservative Surgery | At the end of Cycle 8 (each cycle length = 21 days) |
| Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | AEs were recorded and graded per the NCI CTCAE scale. The NCI CTCAE is a toxicity scale used to grade the severity of adverse events experienced with cancer treatment. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening or disabling; Grade 5= Death related to AE. For summaries for the toxicity grade, participants were counted once at the greatest NCI CTCAE grade. | Up to Week 24 |
| Vienna |
| Austria |
| Teva Investigational Site 9 | Brussels | Belgium |
| Teva Investigational Site 29 | Yvoir | Belgium |
| Teva Investigational Site 4 | Clichy | France |
| Teva Investigational Site 5 | Nancy | France |
| Teva Investigational Site 33 | Reims | France |
| Teva Investigational Site 8 | Vandœuvre-lès-Nancy | France |
| Teva Investigational Site 30 | Aachen | Germany |
| Teva Investigational Site 11 | Düsseldorf | Germany |
| Teva Investigational Site 25 | Düsseldorf | Germany |
| Teva Investigational Site 32 | Essen | Germany |
| Teva Investigational Site 34 | Loerrach | Germany |
| Teva Investigational Site 14 | München | Germany |
| Teva Investigational Site 27 | München | Germany |
| Teva Investigational Site 20 | Naples | Italy |
| Teva Investigational Site 23 | Roma | Italy |
| Teva Investigational Site 21 | Verona | Italy |
| Teva Investigational Site 26 | Barcelona | Spain |
| Teva Investigational Site 3 | Barcelona | Spain |
| Teva Investigational Site 1 | Lleida | Spain |
| Teva Investigational Site 2 | Zaragoza | Spain |
| FG001 | Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Participants received AC (free doxorubicin hydrochloride [60 mg/m^2] and cyclophosphamide [600 mg/m^2]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [8 or 6 mg/kg]). For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. |
| Received at Least 1 Dose of Study Drug |
|
| Completed 8 Cycles of Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Participants received MCH (liposomal doxorubicin hydrochloride [60 mg/m^2], cyclophosphamide (600 mg/m^2), and trastuzumab (8 or 6 mg/kg), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. After 4 cycles of MCH, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [6 mg/kg]). |
| BG001 | Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Participants received AC (free doxorubicin hydrochloride [60 mg/m^2] and cyclophosphamide [600 mg/m^2]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [8 or 6 mg/kg]). For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast | The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue . | The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug. | Posted | Number | percentage of participants | At the end of Cycle 8 (each cycle length = 21 days) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines | CR: Disappearance of the lesions and no new lesions. In case of bone metastasis a CR is represented by the normalization of radiography or the complete sclerotic healing of lytic area. PR: In the case of bidimensionally measurable lesions/tumors, a decrease by at least 50% of the sum of the products of the largest perpendicular diameters of each individual lesion/tumor. In the case of unidimensionally measurable lesions a decrease by at least 50% in the largest linear tumour measurement. In the case of non-measurable but evaluable lesions an appreciable change of lesions referable to disease improvement. For bone lesions partial decrease in size or recalcification of lytic areas. No lesion should have progressed and no new lesion should appear. | The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug. | Posted | Number | percentage of participants | At the end of Cycle 8 (each cycle length = 21 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF) | Occurrence of Class III or IV (NYHA) CHF has been reported. Class III: Participants with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug. | Posted | Number | percentage of participants | Baseline up to the end of Cycle 8 (each cycle length = 21 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). LVEF was measured using multigated acquisition (MUGA) or echocardiography. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here, 'Number analyzed' = participants evaluable for specified category. | Posted | Mean | Standard Deviation | percentage of blood pumped out | Baseline, up to 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. AEs included both SAEs and non-serious AEs. The TEAE was an AE that began or worsened after treatment with study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to the end of Cycle 8 (cycle length = 21 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progression or Death | Progression was defined as a 25% or more increase in the size of the lesion or appearance of new lesion. If the participant did not develop an event (disease progression or death), the participant was censored at the last known tumor assessment date (or last follow-up visit without progression documented). | The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug. | Posted | Number | percentage of participants | Up to 5 Years after randomization |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node | The pCR of breast and node was based upon histologic examination, as confirmed by a central panel of experts, of breast tissue resected. | The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug. | Posted | Number | percentage of participants | At the end of Cycle 8 (each cycle length = 21 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Undergoing Breast Conservative Surgery | The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug. | Posted | Count of Participants | Participants | At the end of Cycle 8 (each cycle length = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | AEs were recorded and graded per the NCI CTCAE scale. The NCI CTCAE is a toxicity scale used to grade the severity of adverse events experienced with cancer treatment. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening or disabling; Grade 5= Death related to AE. For summaries for the toxicity grade, participants were counted once at the greatest NCI CTCAE grade. | Safety analysis set | Posted | Count of Participants | Participants | Up to Week 24 |
|
Up to 5 years after randomization
The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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 | Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Participants received MCH (liposomal doxorubicin hydrochloride [60 mg/m^2], cyclophosphamide (600 mg/m^2), and trastuzumab (8 or 6 mg/kg), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. After 4 cycles of MCH, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [6 mg/kg]). | 0 | 62 | 18 | 62 | 62 | 62 |
| EG001 | Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Participants received AC (free doxorubicin hydrochloride [60 mg/m^2] and cyclophosphamide [600 mg/m^2]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [8 or 6 mg/kg]). For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. | 4 | 63 | 21 | 63 | 63 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Whiplash injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Acute polyneuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products R&D, Inc. | 1-888-483-8279 | USMedInfo@tevapharm.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 |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D000068878 | Trastuzumab |
| D018943 | Anthracyclines |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| OG001 | Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Participants received AC (free doxorubicin hydrochloride [60 mg/m^2] and cyclophosphamide [600 mg/m^2]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [8 or 6 mg/kg]). For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. |
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Participants received AC (free doxorubicin hydrochloride [60 mg/m^2] and cyclophosphamide [600 mg/m^2]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [8 or 6 mg/kg]). For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. |
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| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) |
Participants received AC (free doxorubicin hydrochloride [60 mg/m^2] and cyclophosphamide [600 mg/m^2]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel [100 mg/m^2] and trastuzumab [8 or 6 mg/kg]). For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. |
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