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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000783-16 |
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This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard chemotherapy | Drug | As prescribed |
| |
| bevacizumab [Avastin] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification | PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders. | From baseline through Week 25 (Up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a PCR According to the Chevallier Classification | PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Besançon | 25030 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22377126 | Derived | Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Trastuzumab Chemotherapy | Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 milligrams per kilogram (mg/kg) intravenous (IV) bevacizumab every 3 weeks (q3w) for 8 cycles, 4 cycles of 500 milligrams per squared-meter (mg/m^2) IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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| Drug |
15mg/kg iv 3 weekly in cycles 1-8 |
|
| trastuzumab [Herceptin] | Drug | 8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8. |
|
| From baseline through Week 25 (Up to 6 months) |
| Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit | Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented. | Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25) |
| Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit | Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented. | Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25) |
| Number of Participants Who Underwent Mastectomy | Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment. | Anytime between Week 26 and Week 29 |
| Percentage of Participants With Macroscopically Visible Tumor | Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported. | Anytime between Week 26 and Week 29 |
| Percentage of Participants Who Underwent Lymph Node Resection | Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades. | Anytime between Week 26 and Week 29 |
| Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit | Baseline, Neoadjuvant Final Visit (Week 25) |
| Percentage of Participants Who Were Disease Free at 3 and 5 Years | A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause. | 3, 5 years |
| Disease Free Survival (DFS) Duration | DFS was estimated using Kaplan-Meier method. | Up to 5 Years |
| Percentage of Participants Who Were Recurrence Free at 3 and 5 Years | A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes). | 3, 5 years |
| Recurrence Free Survival (RFS) Duration | RFS was estimated using Kaplan-Meier method. | Up to 5 Years |
| Percentage of Participants Who Were Alive at 3 and 5 Years | 3, 5 years |
| Overall Survival (OS) Duration | OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method. | Up to 5 years |
| Bordeaux |
| 33000 |
| France |
| Brest | 29609 | France |
| Caen | 14076 | France |
| Clermont-Ferrand | 63011 | France |
| Dijon | 21079 | France |
| La Tronche | 38700 | France |
| Lille | 59020 | France |
| Lyon | 69373 | France |
| Marseille | 13273 | France |
| Montpellier | 34298 | France |
| Nantes | 44202 | France |
| Nice | 06189 | France |
| Paris | 75231 | France |
| Paris | 75475 | France |
| Paris | 75970 | France |
| Reims | 51056 | France |
| Rennes | 35042 | France |
| Rouen | 76038 | France |
| Saint-Brieuc | 22015 | France |
| Saint-Cloud | 92210 | France |
| Saint-Herblain | 44805 | France |
| Saint-Priest-en-Jarez | 42271 | France |
| Strasbourg | 67065 | France |
| Strasbourg | 67098 | France |
| Toulouse | 31059 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Villejuif | 94805 | France |
| COMPLETED |
|
| NOT COMPLETED |
|
Intent to treat population (ITT): Included all enrolled participants who had at least 1 post baseline assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Trastuzumab | Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification | PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline through Week 25 (Up to 6 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With a PCR According to the Chevallier Classification | PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline through Week 25 (Up to 6 months) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit | Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented. | ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed and were evaluated for response from baseline assessment of inflammatory signs. n included number of participants who were evaluable at a particular time point. | Posted | Number | percentage of participants | Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit | Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented. | ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed. n included number of participants who were evaluable at a particular time point. | Posted | Number | percentage of participants | Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Underwent Mastectomy | Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment. | ITT population. | Posted | Number | participants | Anytime between Week 26 and Week 29 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Macroscopically Visible Tumor | Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported. | ITT population. Included participants who underwent mastectomy. | Posted | Number | percentage of participants | Anytime between Week 26 and Week 29 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Underwent Lymph Node Resection | Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades. | ITT population. Included participants who underwent mastectomy. | Posted | Number | percentage of participants | Anytime between Week 26 and Week 29 |
|
| |||||||||||||||||||||||||||
| Secondary | Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit | Safety population: Number of participants included all the participants who received at least one infusion of bevacizumab. n included participants who were evaluable at that time point. | Posted | Mean | Standard Deviation | Units per milliliter (U/mL) | Baseline, Neoadjuvant Final Visit (Week 25) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Disease Free at 3 and 5 Years | A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | 3, 5 years |
| |||||||||||||||||||||||||||
| Secondary | Disease Free Survival (DFS) Duration | DFS was estimated using Kaplan-Meier method. | ITT population. | Posted | Median | 95% Confidence Interval | months | Up to 5 Years |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Recurrence Free at 3 and 5 Years | A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes). | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | 3, 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Recurrence Free Survival (RFS) Duration | RFS was estimated using Kaplan-Meier method. | ITT population. | Posted | Median | 95% Confidence Interval | months | Up to 5 Years |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Alive at 3 and 5 Years | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | 3, 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Duration | OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method. | ITT population. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
|
|
From Baseline until end of study (Up to approximately 6 years)
Not provided
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 | Bevacizumab + Trastuzumab | Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive. | 20 | 52 | 52 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Incision site abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nasal septum perforation | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.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 |
|---|---|
| D000068258 | Bevacizumab |
| D000068878 | Trastuzumab |
| 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
|
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| Units | Counts |
|---|---|
| Participants |
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