Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006556-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus + Paclitaxel + Trastuzumab | Experimental | Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 |
|
| Placebo + Paclitaxel + Trastuzumab | Placebo Comparator | Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population. | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months |
| Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population. | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) - Full Population | OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst. | Mobile | Alabama | 36688 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28399902 | Derived | Toi M, Shao Z, Hurvitz S, Tseng LM, Zhang Q, Shen K, Liu D, Feng J, Xu B, Wang X, Lee KS, Ng TY, Ridolfi A, Noel-Baron F, Ringeisen F, Jiang Z. Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1. Breast Cancer Res. 2017 Apr 11;19(1):47. doi: 10.1186/s13058-017-0839-0. | |
| 26861602 |
Not provided
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
Not provided
717 patients were planned to be randomized. A total of 719 patients were randomized between 10-Sep-2009 and 16-Dec-2012.
Not completed reasons = primary reasons for end of treatment
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus + Paclitaxel + Trastuzumab | Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 |
| FG001 | Placebo + Paclitaxel + Trastuzumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets). |
|
| Trastuzumab | Drug | Trastuzumab, 2 mg/kg weekly was used intravenously. |
|
| Paclitaxel | Drug | Paclitaxel, 80 mg/m2 weekly was used intravenously. |
|
| up to about 76 months |
| Overall Survival (OS) - HR-negative Population | OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population. | up to about 76 months |
| Overall Response Rate (ORR) - Full Population | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Overall Response Rate (ORR) - HR-negative Population | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population | CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population | CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Time to Overall Response Based on Investigator - Full Population | Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Time to Overall Response Based on Investigator - HR-negative Population | Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Overall Response (OR) - Full Population | OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Overall Response (OR) - HR-negative Population | OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | up to about 23 months |
| Everolimus Blood Level Concentrations at Steady States for Everolimus | Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days | predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22 |
| Paclitaxel Plasma Concentrations | Blood levels at steady states for everolimus/placebo | Cycle 2/Day 15 (Pre-infusion and end of infusion) |
| Trastuzumab Serum Concentrations | Blood levels at steady states for everolimus/placebo | Cycle 4/Day 1 (Pre-infusion and end of infusion) |
| Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population | Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. | up to about 56 months |
| Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population | Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. | up to about 56 months |
| Ironwood Cancer and Research Centers |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| Comprehensive Blood and Cancer Center Dept. of CBCC (2) | Bakersfield | California | 93309 | United States |
| St. Jude Heritage Medical Group Virginia Crosson Cancer Center | Fullerton | California | 92835 | United States |
| University of California at Los Angeles Dept. of UCLA | Los Angeles | California | 90095 | United States |
| Ventura County Hematology and Oncology | Oxnard | California | 93030 | United States |
| Cancer Care Associates Medical Group Dept. of CCA | Redondo Beach | California | 90277 | United States |
| Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc | Santa Barbara | California | 93105 | United States |
| Central Coast Medical Oncology Corporation Onc Dept | Santa Maria | California | 93454 | United States |
| Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3) | Greenwood Village | Colorado | United States |
| Florida Cancer Specialists Dept.of FloridaCancerSpec. (2) | Fort Myers | Florida | 33901 | United States |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| Central Indiana Cancer Centers CICC - East (3) | Indianapolis | Indiana | 46227 | United States |
| Kansas City Cancer Center Dept. of KCCC | Overland Park | Kansas | 66210 | United States |
| University of Nebraska Medical Center Unv Nebraska Med Ctr (2) | Omaha | Nebraska | 68198 | United States |
| New York Oncology Hematology NYOH Amsterdam | Albany | New York | 12208 | United States |
| Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2) | New York | New York | 10003 | United States |
| Northwest Cancer Specialists Vancouver Cancer Center (3) | Portland | Oregon | 97210 | United States |
| Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5) | Nashville | Tennessee | 37203 | United States |
| Texas Oncology Charles A. Sammons Cancer Ctr | Dallas | Texas | 75246 | United States |
| Texas Oncology P A SC-Austin | Dallas | Texas | 75251 | United States |
| Tyler Cancer Center Dept.ofTylerCancerCtr. (2) | Tyler | Texas | 75702 | United States |
| Virginia Oncology Associates SC | Norfolk | Virginia | 23502 | United States |
| Virginia Cancer Institute VCI (3) | Richmond | Virginia | 23230 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1050AAK | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | B7600CTO | Argentina |
| Novartis Investigative Site | Posadas | Misiones Province | Argentina |
| Novartis Investigative Site | Rosario | Sante Fe | S200KZE | Argentina |
| Novartis Investigative Site | Rio Negro | Viedma | 8500 | Argentina |
| Novartis Investigative Site | Capital Federal | 1417 | Argentina |
| Novartis Investigative Site | Córdoba | X5004BAL | Argentina |
| Novartis Investigative Site | Southport | Queensland | 4215 | Australia |
| Novartis Investigative Site | East Bentleigh | Victoria | 3165 | Australia |
| Novartis Investigative Site | Charleroi | 6000 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Verviers | 4800 | Belgium |
| Novartis Investigative Site | Wilrijk | 2610 | Belgium |
| Novartis Investigative Site | Yvoir | 5530 | Belgium |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | 30380-490 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 20230-130 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01246 000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04038-001 | Brazil |
| Novartis Investigative Site | Montreal | Quebec | H2W 1S6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H4J 1C5 | Canada |
| Novartis Investigative Site | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Novartis Investigative Site | Guangzhou | Guangdong | 51000 | China |
| Novartis Investigative Site | Harbin | Heilongjiang | 150081 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210002 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210009 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200032 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310022 | China |
| Novartis Investigative Site | Beijing | 100021 | China |
| Novartis Investigative Site | Beijing | 100039 | China |
| Novartis Investigative Site | Guangzhou | 510060 | China |
| Novartis Investigative Site | Shanghai | 200025 | China |
| Novartis Investigative Site | Bogota | Cundinamarca | 0000 | Colombia |
| Novartis Investigative Site | Bogotá | Colombia |
| Novartis Investigative Site | Florida Blanca | Colombia |
| Novartis Investigative Site | Montería | Colombia |
| Novartis Investigative Site | Alexandria | Egypt |
| Novartis Investigative Site | Cairo | Egypt |
| Novartis Investigative Site | Limoges | 87000 | France |
| Novartis Investigative Site | Rouen | 76000 | France |
| Novartis Investigative Site | Saint-Herblain Cédex | 44805 | France |
| Novartis Investigative Site | Strasbourg | F 67098 | France |
| Novartis Investigative Site | Thonon-les-Bains | 74203 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Berlin | 10098 | Germany |
| Novartis Investigative Site | Chemnitz | 09113 | Germany |
| Novartis Investigative Site | Esslingen am Neckar | 73730 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Heraklion Crete | Greece | 711 10 | Greece |
| Novartis Investigative Site | Athens | GR | 151 23 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 564 03 | Greece |
| Novartis Investigative Site | Athens | 115 28 | Greece |
| Novartis Investigative Site | Athens | 18547 | Greece |
| Novartis Investigative Site | Shatin, New Territories | Hong Kong | Hong Kong |
| Novartis Investigative Site | Hong Kong SAR | Hong Kong |
| Novartis Investigative Site | Tuenmen | Hong Kong |
| Novartis Investigative Site | Wilton | Cork | Ireland |
| Novartis Investigative Site | Dublin | Ireland |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Modena | MO | 41124 | Italy |
| Novartis Investigative Site | Camposampiero | PD | 35012 | Italy |
| Novartis Investigative Site | Roma | RM | 00128 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 464-8681 | Japan |
| Novartis Investigative Site | Kashiwa | Chiba | 277-8577 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 811-1395 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 802-0077 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371 8511 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060 8648 | Japan |
| Novartis Investigative Site | Isehara | Kanagawa | 259-1193 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Sakyo-ku | Kyoto | 606 8507 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 540-0006 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 104-8560 | Japan |
| Novartis Investigative Site | Osaka | 537-8511 | Japan |
| Novartis Investigative Site | Beirut | 1107 2020 | Lebanon |
| Novartis Investigative Site | El Achrafiyé | 166830 | Lebanon |
| Novartis Investigative Site | Mexico City | Mexico City | 04980 | Mexico |
| Novartis Investigative Site | Zaragoza | Veracruz | 91910 | Mexico |
| Novartis Investigative Site | San Borja | Lima region | 41 | Peru |
| Novartis Investigative Site | Surquillo | Lima region | 34 | Peru |
| San Juan VA Hospital San Juan Hospital | San Juan | 00921 | Puerto Rico |
| Novartis Investigative Site | Kazan' | Tatarstan Republic | 420029 | Russia |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | Moscow | 129128 | Russia |
| Novartis Investigative Site | Moscow | 143423 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Saint Petersburg | 198255 | Russia |
| Novartis Investigative Site | Bloemfontein | 9301 | South Africa |
| Novartis Investigative Site | Durban | 4091 | South Africa |
| Novartis Investigative Site | Pretoria | 0002 | South Africa |
| Novartis Investigative Site | Gyeonggi-do | Korea | 10408 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06351 | South Korea |
| Novartis Investigative Site | Seoul | 02841 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Geneva | 1211 | Switzerland |
| Novartis Investigative Site | Zurich | 8038 | Switzerland |
| Novartis Investigative Site | Taipei | Taiwan, ROC | 11217 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 80756 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Altunizade | 34662 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35340 | Turkey (Türkiye) |
| Novartis Investigative Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Novartis Investigative Site | London | SW3 6JJ | United Kingdom |
| Novartis Investigative Site | Sutton | SM2 5PT | United Kingdom |
| Novartis Investigative Site | Valencia | Carabobo | 2001 | Venezuela |
| Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance-too much of a good thing .... Ann Oncol. 2016 May;27(5):760-2. doi: 10.1093/annonc/mdw047. Epub 2016 Feb 9. |
| 26092818 | Derived | Hurvitz SA, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, Tseng LM, Zhang Q, Shen K, Liu D, Dreosti LM, Burris HA, Toi M, Buyse ME, Cabaribere D, Lindsay MA, Rao S, Pacaud LB, Taran T, Slamon D. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Lancet Oncol. 2015 Jul;16(7):816-29. doi: 10.1016/S1470-2045(15)00051-0. Epub 2015 Jun 16. |
Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
| Untreated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The FAS consisted of all randomized patients. Following the intent-to-treat principle patients were analyzed according to the treatment and stratum they were assigned to at randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus + Paclitaxel + Trastuzumab | Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 |
| BG001 | Placebo + Paclitaxel + Trastuzumab | Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 |
| 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 | Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population. | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | Posted | Median | 95% Confidence Interval | months | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population | PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population. | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline. | Posted | Median | 95% Confidence Interval | Months | date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Full Population | OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population. | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. Due to the exploratory nature of the OS analysis, OS was not statistically tested | Posted | Median | 95% Confidence Interval | Months | up to about 76 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - HR-negative Population | OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population. | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline. Due to the exploratory nature of the OS analysis, OS was not statistically tested. | Posted | Median | 95% Confidence Interval | Months | up to about 76 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) - Full Population | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | up to about 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) - HR-negative Population | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | up to about 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population | CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | up to about 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population | CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | up to about 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Overall Response Based on Investigator - Full Population | Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | Posted | Median | 95% Confidence Interval | months | up to about 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Overall Response Based on Investigator - HR-negative Population | Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | Posted | Median | 95% Confidence Interval | months | up to about 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response (OR) - Full Population | OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | Posted | Number | Percentage of participants | up to about 23 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response (OR) - HR-negative Population | OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit. | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | Posted | Number | Percentage of participants | up to about 23 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Everolimus Blood Level Concentrations at Steady States for Everolimus | Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days | Safety Set: consists of all patients who received at least 1 dose of study treatment & have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment. | Posted | Mean | Standard Deviation | ng/mL | predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Paclitaxel Plasma Concentrations | Blood levels at steady states for everolimus/placebo | Safety Set: consists of all patients who received at least 1 dose of study treatment & have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment. | Posted | Mean | Standard Deviation | ng/mL | Cycle 2/Day 15 (Pre-infusion and end of infusion) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trastuzumab Serum Concentrations | Blood levels at steady states for everolimus/placebo | Safety Set: consists of all patients who received at least 1 dose of study treatment & have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment. | Posted | Mean | Standard Deviation | microgram/ml | Cycle 4/Day 1 (Pre-infusion and end of infusion) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population | Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. | The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. | Posted | Median | 95% Confidence Interval | months | up to about 56 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population | Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. | HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline | Posted | Median | 95% Confidence Interval | months | up to about 56 months |
|
|
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until 30 days after Last Patient Last Visit.
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 | Everolimus+ Paclitaxel+ Trastuzumab | Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 | 23 | 472 | 173 | 472 | 466 | 472 |
| EG001 | Placebo+ Paclitaxel+ Trastuzumab | Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 | 2 | 238 | 40 | 238 | 236 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ocular surface disease | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Calcinosis | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary tuberculoma | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA (20.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Breast ulceration | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
Of the 480 patients enrolled in the Everolimus arm, 8 were untreated and in the Placebo arm, of the 239 patients enrolled, 1 was untreated.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| 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 |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Other |
|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|