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| ID | Type | Description | Link |
|---|---|---|---|
| TDM4370g | Other Identifier | Genentech |
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This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab emtansine | Experimental | Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination. |
|
| Lapatinib + Capecitabine | Active Comparator | Participants will receive lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Eligible participants will cross over to receive trastuzumab emtansine if second interim analysis demonstrates statistically significant overall survival benefit in favor of trastuzumab emtansine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab emtansine | Drug | Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) | PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) | Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Percentage of Participants Who Died: Second Interim Analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PD or Death as Assessed by the Investigator | PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler | Arizona | 85224 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28526536 | Derived | Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16. | |
| 23020162 |
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Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant Overall Survival (OS) benefit in favor of trastuzumab emtansine demonstrated in second interim analysis (cut-off date 31 July 2012). The safety analysis of the arm was then reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Emtansine | Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lapatinib | Drug | Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle. |
|
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| Capecitabine | Drug | Capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle. |
|
|
The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory. |
| From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) |
| Overall Survival: Second Interim Analysis (Co-primary Endpoint) | OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory. | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) |
| Percentage of Participants Who Died: Final Analysis | The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive. | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) |
| Overall Survival: Final Analysis | OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive. | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) |
| Percentage of Participants Who Were Alive at Year 1 | 1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis. | Year 1 |
| Percentage of Participants Who Were Alive at Year 2 | 2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis. | Year 2 |
| From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| PFS as Assessed by the Investigator | Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Percentage of Participants With Objective Response (OR) as Assessed by an IRC | Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Duration of Objective Response (DOR) as Assessed by an IRC | Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Percentage of Participants With Clinical Benefit as Assessed by an IRC | Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Percentage of Participants With Treatment Failure | Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Time to Treatment Failure | Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Percentage of Participants With Symptom Progression | Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Time to Symptom Progression | Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Anaheim | California | 92801 | United States |
| Anaheim | California | 92807 | United States |
| Bakersfield | California | 93309 | United States |
| Baldwin Park | California | 91706 | United States |
| Bellflower | California | 90706 | United States |
| Duarte | California | 91010 | United States |
| Fontana | California | 92335 | United States |
| Hayward | California | 94545 | United States |
| Irvine | California | 92618 | United States |
| La Jolla | California | 92093 | United States |
| La Mesa | California | 91942 | United States |
| Loma Linda | California | 92354 | United States |
| Long Beach | California | 90806 | United States |
| Los Angeles | California | 90025 | United States |
| Los Angeles | California | 90034 | United States |
| Los Angeles | California | 90057 | United States |
| Los Angeles | California | 90095-1772 | United States |
| Montebello | California | 90640 | United States |
| Newport Beach | California | 92660 | United States |
| Oakland | California | 94611 | United States |
| Panorama City | California | 91402 | United States |
| Riverside | California | 92505 | United States |
| Roseville | California | 95661 | United States |
| Sacramento | California | 95825 | United States |
| San Diego | California | 92120 | United States |
| San Diego | California | 92123 | United States |
| San Francisco | California | 94115 | United States |
| San Jose | California | 95119 | United States |
| Santa Clara | California | 95051 | United States |
| Santa Maria | California | 93454 | United States |
| Santa Monica | California | 90404 | United States |
| South San Francisco | California | 94080 | United States |
| Thousand Oaks | California | 91360 | United States |
| Vallejo | California | 94589 | United States |
| Walnut Creek | California | 94596 | United States |
| Woodland Hills | California | 91367 | United States |
| Fort Collins | Colorado | 80528 | United States |
| Norwalk | Connecticut | 06856 | United States |
| Norwich | Connecticut | 06360 | United States |
| Stamford | Connecticut | 06902 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Boca Raton | Florida | 33486 | United States |
| Fernandina Beach | Florida | 32034 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Fort Myers | Florida | 33916 | United States |
| Hollywood | Florida | 33021 | United States |
| Jacksonville | Florida | 32205 | United States |
| Jacksonville | Florida | 32207 | United States |
| Jacksonville | Florida | 32256 | United States |
| Jacksonville | Florida | 32258 | United States |
| Kissimmee | Florida | 34741 | United States |
| Lakeland | Florida | 33804-1057 | United States |
| Miami | Florida | 33133 | United States |
| Miami | Florida | 33136 | United States |
| Miami | Florida | 33176 | United States |
| Orange Park | Florida | 32073 | United States |
| Pembroke Pines | Florida | 33028 | United States |
| Athens | Georgia | 30607 | United States |
| Atlanta | Georgia | 30318 | United States |
| Atlanta | Georgia | 30322 | United States |
| Atlanta | Georgia | 30341 | United States |
| Atlanta | Georgia | 30342 | United States |
| Carrolton | Georgia | 30117 | United States |
| Cartersville | Georgia | 30121 | United States |
| Decatur | Georgia | 30033 | United States |
| Douglasville | Georgia | 30134 | United States |
| Macon | Georgia | 31217 | United States |
| Marietta | Georgia | 30060 | United States |
| Boise | Idaho | 83712 | United States |
| Meridian | Idaho | 83642 | United States |
| Nampa | Idaho | 83686 | United States |
| Post Falls | Idaho | 83854 | United States |
| Twin Falls | Idaho | 83301 | United States |
| Chicago | Illinois | 60612 | United States |
| Decatur | Illinois | 62526 | United States |
| Effingham | Illinois | 62526 | United States |
| Joliet | Illinois | 60435 | United States |
| Morris | Illinois | 60450 | United States |
| Peoria | Illinois | 61615-7828 | United States |
| Skokie | Illinois | 60076 | United States |
| Zion | Illinois | 60099 | United States |
| Bettendorf | Iowa | 52722 | United States |
| Wichita | Kansas | 67214-3728 | United States |
| Paducah | Kentucky | 42001 | United States |
| Covington | Louisiana | 70433 | United States |
| Lafayette | Louisiana | 70503 | United States |
| Marrero | Louisiana | 70072 | United States |
| Metairie | Louisiana | 70006 | United States |
| New Orleans | Louisiana | 70115 | United States |
| Kittery | Maine | 03904 | United States |
| Wells | Maine | 04090 | United States |
| York Village | Maine | 03909 | United States |
| Baltimore | Maryland | 21202 | United States |
| Baltimore | Maryland | 21237 | United States |
| Bethesda | Maryland | 20817 | United States |
| Rockville | Maryland | 20850 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02115 | United States |
| Boston | Massachusetts | 02118 | United States |
| Boston | Massachusetts | 02215 | United States |
| Burlington | Massachusetts | 01805 | United States |
| Peabody | Massachusetts | 01960 | United States |
| Brownstown | Michigan | 48183 | United States |
| Dearborn | Michigan | 48126 | United States |
| Detroit | Michigan | 48201 | United States |
| Detroit | Michigan | 48202 | United States |
| Saint Joseph | Michigan | 49085 | United States |
| West Bloomfield | Michigan | 48322 | United States |
| Edina | Minnesota | 55414 | United States |
| Maplewood | Minnesota | 55109 | United States |
| Minneapolis | Minnesota | 55454 | United States |
| Saint Louis Park | Minnesota | 55426 | United States |
| Saint Paul | Minnesota | 55101 | United States |
| City of Saint Peters | Missouri | 63110 | United States |
| City of Saint Peters | Missouri | 63376 | United States |
| Joplin | Missouri | 64804 | United States |
| Kansas City | Missouri | 64111 | United States |
| St Louis | Missouri | 63110 | United States |
| St Louis | Missouri | 63141 | United States |
| Missoula | Montana | 59802 | United States |
| Omaha | Nebraska | 68114 | United States |
| Henderson | Nevada | 89052 | United States |
| Cherry Hill | New Jersey | 08002 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Morristown | New Jersey | 07962 | United States |
| Parsippany | New Jersey | 07054 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| Santa Fe | New Mexico | 87505 | United States |
| Brockport | New York | 14420 | United States |
| Canandaigua | New York | 14424 | United States |
| Fresh Meadows | New York | 11366 | United States |
| Geneva | New York | 14456 | United States |
| Greece | New York | 14626 | United States |
| Lake Success | New York | 11042 | United States |
| Mount Kisco | New York | 10549 | United States |
| Rochester | New York | 14626 | United States |
| Stony Brook | New York | 11794 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Durham | North Carolina | 27710 | United States |
| Hickory | North Carolina | 28602 | United States |
| Kinston | North Carolina | 28501 | United States |
| Washington | North Carolina | 27889 | United States |
| Cleveland | Ohio | 44106 | United States |
| Cleveland | Ohio | 44195 | United States |
| Columbus | Ohio | 43215 | United States |
| Columbus | Ohio | 43219 | United States |
| Columbus | Ohio | 43228 | United States |
| Middletown | Ohio | 45042 | United States |
| Newark | Ohio | 43055 | United States |
| Sandusky | Ohio | 44870 | United States |
| Portland | Oregon | 97227 | United States |
| Philadelphia | Pennsylvania | 19106 | United States |
| Philadelphia | Pennsylvania | 19124 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| East Providence | Rhode Island | 02915 | United States |
| Columbia | South Carolina | 29210 | United States |
| North Charleston | South Carolina | 29425 | United States |
| Memphis | Tennessee | 38120 | United States |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78731 | United States |
| Bryan | Texas | 77802 | United States |
| Cypress | Texas | 77429 | United States |
| Dallas | Texas | 75230 | United States |
| El Paso | Texas | 79902 | United States |
| Houston | Texas | 77090 | United States |
| Shenandoah | Texas | 77384 | United States |
| Temple | Texas | 76501 | United States |
| Fairfax | Virginia | 22031 | United States |
| Gig Harbor | Washington | 98332 | United States |
| Lakewood | Washington | 98499 | United States |
| Puyallup | Washington | 98372 | United States |
| Tacoma | Washington | 98405 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Wausau | Wisconsin | 54401 | United States |
| Banja Luka | 78000 | Bosnia and Herzegovina |
| Sarajevo | 71000 | Bosnia and Herzegovina |
| Belo Horizonte | 30150-281 | Brazil |
| Curitiba | 80530-010 | Brazil |
| Goiânia | 74605-070 | Brazil |
| Itajaà | 88301-220 | Brazil |
| Jaú | 17210-080 | Brazil |
| João Pessoa | 58040280 | Brazil |
| Porto Alegre | 90430-090 | Brazil |
| Porto Alegre | 90610-000 | Brazil |
| Porto Alegre | 91350-200 | Brazil |
| Porto Alegre - Rs | 90050-170 | Brazil |
| Rio de Janeiro | 20560-120 | Brazil |
| Rio de Janeiro | 22260-020 | Brazil |
| Santo André | 09060-870 | Brazil |
| São Paulo | 01317-000 | Brazil |
| São Paulo | 1323020 | Brazil |
| Plovdiv | 4000 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Sofia | 1784 | Bulgaria |
| Varna | 9002 | Bulgaria |
| Calgary | Alberta | T2N 4N2 | Canada |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| Kelowna | British Columbia | V1Y 5L3 | Canada |
| Vancouver | British Columbia | V5Z 1H5 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Greater Sudbury | Ontario | J9P 3Y1 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H2W 1T8 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Bogotá | 0 | Colombia |
| Bogotá | 49 00 | Colombia |
| MonterÃa | Colombia |
| Copenhagen | 2100 | Denmark |
| Herlev | 2730 | Denmark |
| Odense | 5000 | Denmark |
| Helsinki | 00180 | Finland |
| Tampere | 33520 | Finland |
| Turku | 20520 | Finland |
| Avignon | 84082 | France |
| Bordeaux | 33076 | France |
| Brest | 29609 | France |
| Caen | 14076 | France |
| Dijon | 21079 | France |
| La Roche-sur-Yon | 85925 | France |
| Montpellier | 34298 | France |
| Paris | 75248 | France |
| Saint-Brieuc | 22015 | France |
| Saint-Herblain | 44805 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Aschaffenburg | 63739 | Germany |
| Berlin | 10367 | Germany |
| Berlin | 13125 | Germany |
| Berlin | 4169 | Germany |
| Bonn | 53113 | Germany |
| Dortmund | 44137 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Fürstenwalde | 15517 | Germany |
| Hamburg | 20357 | Germany |
| Karlsruhe | 76135 | Germany |
| Kiel | 24105 | Germany |
| Offenbach | 63069 | Germany |
| Stralsund | 18435 | Germany |
| Hong Kong | Hong Kong |
| Bangalore | 560027 | India |
| Gurgaon | 122001 | India |
| Kolkata | 700 053 | India |
| New Delhi | 110029 | India |
| Pune | 411004 | India |
| Aviano | 33081 | Italy |
| Bologna | 40138 | Italy |
| Candiolo | 10060 | Italy |
| Genova | 16132 | Italy |
| Meldola | 47014 | Italy |
| Milan | 20133 | Italy |
| Milan | 20141 | Italy |
| Naples | 80131 | Italy |
| Negrar | 37024 | Italy |
| Pisa | 56100 | Italy |
| Reggio Emilia | 42100 | Italy |
| Roma | 00168 | Italy |
| Rozzano | 20089 | Italy |
| Sassari | 07100 | Italy |
| Terni | 05100 | Italy |
| Acapulco | 39670 | Mexico |
| Oaxaca City | 68000 | Mexico |
| Toluca | 50180 | Mexico |
| Newtown | 6021 | New Zealand |
| Palmerston North | 4442 | New Zealand |
| Diliman, Quezon City | 1100 | Philippines |
| Quezon City, Luzon | 1101 | Philippines |
| Bialystok | 15-027 | Poland |
| Gdansk | 80-952 | Poland |
| Krakow | 31-531 | Poland |
| Lublin | 20-090 | Poland |
| Opole | 45-060 | Poland |
| Poznan | 61-866 | Poland |
| Warsaw | 02-781 | Poland |
| Coimbra | 3000-075 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4200-072 | Portugal |
| Kemerovo | 650036 | Russia |
| Moscow | 121356 | Russia |
| Saint Petersburg | 197758 | Russia |
| Singapore | 119074 | Singapore |
| Singapore | 169610 | Singapore |
| Ljubljana | 1000 | Slovenia |
| Kyunggi-do | 411-769 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Barcelona | 08035 | Spain |
| Córdoba | 14004 | Spain |
| Lleida | 25198 | Spain |
| Madrid | 28041 | Spain |
| Madrid | 28046 | Spain |
| Santander | 39008 | Spain |
| Seville | 41013 | Spain |
| Valencia | 46009 | Spain |
| Zaragoza | 50009 | Spain |
| Eskilstuna | 63188 | Sweden |
| Gaelve | 80187 | Sweden |
| Gothenburg | 40036 | Sweden |
| Lucerne | 6004 | Switzerland |
| Sankt Gallen | 9007 | Switzerland |
| Kaohsung | 883 | Taiwan |
| Taichung | 404 | Taiwan |
| Taichung | 407 | Taiwan |
| Taipei | 112 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Bournemouth | BH7 7DW | United Kingdom |
| Cardiff | CF14 2TL | United Kingdom |
| Denbigh | LL18 5UJ | United Kingdom |
| London | SE1 7EH | United Kingdom |
| London | SW3 6JJ | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| New Castle Upon Tyne | NE7 7DN | United Kingdom |
| Northwood | HA6 2RN | United Kingdom |
| Poole | BH15 2JB | United Kingdom |
| Preston | PR2 9HT | United Kingdom |
| Romford | RM7 0AG | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
| Weston-super-Mare | BS23 4TQ | United Kingdom |
| Derived |
| Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1. |
| 22437872 | Derived | Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236. |
| Lapatinib + Capecitabine |
Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants on the basis of the treatment assigned at randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab Emtansine | Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. |
| BG001 | Lapatinib + Capecitabine | Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
| 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 | Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) | PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Number | percentage of participants | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) | Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Died: Second Interim Analysis | The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Number | percentage of participants | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) |
| |||||||||||||||||||||||||||||||
| Primary | Overall Survival: Second Interim Analysis (Co-primary Endpoint) | OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Died: Final Analysis | The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Number | percentage of participants | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) |
| |||||||||||||||||||||||||||||||
| Primary | Overall Survival: Final Analysis | OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Were Alive at Year 1 | 1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Year 1 |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Were Alive at Year 2 | 2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Year 2 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PD or Death as Assessed by the Investigator | PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Number | percentage of participants | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| |||||||||||||||||||||||||||||||
| Secondary | PFS as Assessed by the Investigator | Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (OR) as Assessed by an IRC | Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response (DOR) as Assessed by an IRC | Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with an objective response were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit as Assessed by an IRC | Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Failure | Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Number | percentage of participants | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Symptom Progression | Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis. | Posted | Number | percentage of participants | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Symptom Progression | Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) |
|
Only study-related serious adverse events (SAEs) were reported from randomization to first treatment; all SAEs and non-SAEs were reported from start of treatment until 30 days after treatment; and thereafter only treatment related SAEs were reported until data cut-off date of 21-Sep-2015 (up to 6 years and 7 months). For participants who crossed over from lapatinib + capecitabine to trastuzumab emtansine, data is reported from time of cross-over until 21-Sep-2015 (up to 3 years and 2 months).
Safety population included participants who received at least 1 dose of study medication. Safety analyses were based on the actual treatment received.
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 Emtansine | Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. | 92 | 490 | 474 | 490 | ||
| EG001 | Lapatinib + Capecitabine | Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. | 99 | 488 | 471 | 488 | ||
| EG002 | Lapatinib + Capecitabine/ Trastuzumab Emtansine | Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. | 19 | 136 | 115 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unmapped (Bacteremia due to infected port) | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fistula of small intestine | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nodular regenerative hyperplasia | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Delayed haemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Labile blood pressure | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Palmar-Plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | 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 that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 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 |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| D000077341 | Lapatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Lapatinib + Capecitabine |
Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
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|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
| OG001 | Lapatinib + Capecitabine | Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
|
|
|
| Lapatinib + Capecitabine |
Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
|
|
| OG001 | Lapatinib + Capecitabine | Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
|
|
|
|
|
|
|
|
Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
|
|
Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis. |
|
|
|