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This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 15mg/kg iv every 3 weeks |
| |
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods. | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods. | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
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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 |
|---|---|---|---|---|---|---|
| Buenos Aires | 1417 | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23569311 | Derived | Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8. |
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The participants were randomized 1:1 using a block design randomization procedure with stratification (for prior adjuvant/neo-adjuvant taxane, trastuzumab as part of adjuvant treatment versus no trastuzumab, estrogen/progesterone receptor hormone receptor status and measurable disease) to avoid an imbalance of important prognostic factors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab + Docetaxel | Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
100mg/m2 iv every 3 weeks |
|
| Herceptin | Drug | 8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks |
|
| Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline |
Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method. |
| Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
| Duration of Response (DR) | DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
| Time to Treatment Failure (TTF) | TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
| Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL. | Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years]) |
| Change From Baseline for FACT-G and FACT-B | FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL. | Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years]) |
| Córdoba |
| 5004 |
| Argentina |
| La Plata | B1902CMK | Argentina |
| Mar del Plata | 7600 | Argentina |
| Mendoza | 5500 | Argentina |
| Salta | 4400 | Argentina |
| San Martin | 1650 | Argentina |
| Santa Fe | 03000 | Argentina |
| Santa Fe | 2000 | Argentina |
| Lismore | New South Wales | 2480 | Australia |
| Newcastle | New South Wales | 2298 | Australia |
| Port Macquarie | New South Wales | 2444 | Australia |
| Wahroonga | New South Wales | 2076 | Australia |
| Wollongong | New South Wales | 2500 | Australia |
| Auchenflower | Queensland | 4066 | Australia |
| Nambour | Queensland | 4560 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Perth | Western Australia | 6000 | Australia |
| Graz | 8036 | Austria |
| Salzburg | 5020 | Austria |
| Vienna | 1090 | Austria |
| Vöcklabruck | 4840 | Austria |
| Banja Luka | 78000 | Bosnia and Herzegovina |
| Sarajevo | 71000 | Bosnia and Herzegovina |
| Tuzla | 75000 | Bosnia and Herzegovina |
| Goiânia | Goiás | 74605-070 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Barretos | São Paulo | 14784-400 | Brazil |
| São Paulo | São Paulo | 01509-010 | Brazil |
| Calgary | Alberta | T2N 4N2 | Canada |
| Vancouver | British Columbia | V5Z 4E6 | Canada |
| Halifax | Nova Scotia | B3H 1V7 | Canada |
| Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Hamilton | Ontario | L8V 5C2 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Montreal | Quebec | H2W 1S6 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Québec | Quebec | G1S 4L8 | Canada |
| Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Prague | 128 08 | Czechia |
| Prague | 150 06 | Czechia |
| Avignon | 84918 | France |
| Besançon | 25030 | France |
| Bordeaux | 33076 | France |
| Caen | 14076 | France |
| Clermont-Ferrand | 63011 | France |
| Dijon | 21079 | France |
| Lille | 59020 | France |
| Montpellier | 34298 | France |
| Villejuif | 94805 | France |
| Parma | Emilia-Romagna | 43100 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Milan | Lombardy | 20133 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Acapulco | 39850 | Mexico |
| Guadalajara | 45100 | Mexico |
| Mérida | 97500 | Mexico |
| Monterrey | 66260 | Mexico |
| Torreón | 27000 | Mexico |
| Bucharest | 022328 | Romania |
| Bucharest | 050098 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Iași | 700106 | Romania |
| Kazan' | 420029 | Russia |
| Moscow | 115478 | Russia |
| Obninsk | 249036 | Russia |
| Ryazan | 390011 | Russia |
| Saint Petersburg | 197758 | Russia |
| Ufa | 450054 | Russia |
| Barcelona | Barcelona | 08003 | Spain |
| Sabadell, Barcelona | Barcelona | 08208 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Izmir | 35100 | Turkey (Türkiye) |
| Sıhhiye, Ankara | 06100 | Turkey (Türkiye) |
| Exeter | EX2 5DW | United Kingdom |
| London | SE1 7EH | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| Preston | PR2 9HT | United Kingdom |
| Rhyl | LL18 5UJ | United Kingdom |
| Stoke-on-Trent | ST4 6QG | United Kingdom |
| Weston-super-Mare | BS23 4TQ | United Kingdom |
| Montevideo | 11200 | Uruguay |
| Montevideo | 11600 | Uruguay |
| FG001 | Trastuzumab + Bevacizumab + Docetaxel | Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population: All randomized participants, regardless of whether they actually received study treatment or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab + Docetaxel | Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively. |
| BG001 | Trastuzumab + Bevacizumab + Docetaxel | Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent. |
| 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 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods. | ITT Population | Posted | Median | 95% Confidence Interval | months | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods. | ITT Population | Posted | Median | 95% Confidence Interval | months | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline | Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method. | ITT Population; only participants with measurable disease at baseline were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DR) | DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. | ITT Population: only participants with a best OR of CR or PR were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
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| Secondary | Time to Treatment Failure (TTF) | TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. | ITT Population | Posted | Median | 95% Confidence Interval | months | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) |
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| Secondary | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL. | ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for FACT-G and FACT-B | FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL. | ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years]) |
|
From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
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 | Trastuzumab + Docetaxel | Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively. | 63 | 206 | 198 | 206 | ||
| EG001 | Trastuzumab + Bevacizumab + Docetaxel | Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent. | 72 | 215 | 202 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Angina gangrenous | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Aphthous stomatitus | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Stomatitus | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Mitral vavle incompetence | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hepatic vein thrombosis | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bartholinitis | Reproductive system and breast disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Breast discharge | Reproductive system and breast disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bipolar I Disorder | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| General physical condition | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Spinal pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Conjuctivitis | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (14.0) | Non-systematic Assessment |
|
The 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 the 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 |
| D000077143 | Docetaxel |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
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|
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent. |
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| OG001 | Trastuzumab + Bevacizumab + Docetaxel | Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent. |
|
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| OG001 | Trastuzumab + Bevacizumab + Docetaxel | Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent. |
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