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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002018-37 | EudraCT Number |
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| Name | Class |
|---|---|
| NSABP Foundation Inc | NETWORK |
| GBG Forschungs GmbH | OTHER |
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This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab | Active Comparator |
| |
| Trastuzumab emtansine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Drug | 6 mg/kg intravenously every 3 weeks, 14 cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-free Survival (IDFS) Rate at 3 Years | IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 3-year IDFS rate in ITT population was estimated using Kaplan Meier (KM) method and the percentage of participants who were event-free 3 years after randomization was estimated. | At Year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ [CIS] of any site). IDFS event was defined as outlined in the description for IDFS rate outcome measure (OM) number 1. 3-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. |
| Measure | Description | Time Frame |
|---|---|---|
| IDFS Rate at 7 Years | IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 7-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 7 years after randomization was estimated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States | ||
| Todd Cancer Institute at Long Beach Memorial Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39813643 | Derived | Geyer CE Jr, Untch M, Huang CS, Mano MS, Mamounas EP, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, D'Hondt V, Conlin AK, Guarneri V, Wapnir IL, Jackisch C, Arce-Salinas C, Fasching PA, DiGiovanna MP, Crown JP, Wuelfing P, Shao Z, Rota Caremoli E, Bonnefoi HR, Hennessy BT, Stamatovic L, Castro-Salguero H, Brufsky AM, Knott A, Siddiqui A, Lambertini C, Boulet T, Nyawira B, Restuccia E, Loibl S; KATHERINE Study Group. Survival with Trastuzumab Emtansine in Residual HER2-Positive Breast Cancer. N Engl J Med. 2025 Jan 16;392(3):249-257. doi: 10.1056/NEJMoa2406070. | |
| 30516102 |
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Participants received either trastuzumab or trastuzumab emtansine (T-DM1). 1 participant randomized to trastuzumab arm was untreated, later re-randomized to T-DM1 arm & received treatment. Another participant in the trastuzumab arm received 13 cycles of trastuzumab & 1 of T-DM1. Both these participants were included in the trastuzumab ITT population and T-DM1 safety analysis. 1 participant in T-DM1 arm received 9 cycles of trastuzumab & included in trastuzumab safety analysis.
A total of 1486 participants with human epidermal growth factor receptor 2 (HER2)-positive primary breast cancer who had residual invasive disease in either the breast or axillary lymph nodes took part in the study at 268 investigative sites across 28 countries from April 03, 2013 to May 23, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab | Participants received trastuzumab, 6 milligram per kilograms (mg/kg), intravenously (IV), every 3 weeks (Q3W), as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
| FG001 | Trastuzumab Emtansine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2021 | May 22, 2025 |
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| trastuzumab emtansine |
| Drug |
3.6 mg/kg intravenously every 3 weeks, 14 cycles |
|
| At Year 3 |
| IDFS Including SPNBC Rate at 7 Years | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | At Year 7 |
| IDFS Including SPNBC Rate at 8 Years | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | At Year 8 |
| Disease-free Survival (DFS) Rate at 3 Years | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral ductal carcinoma in situ (DCIS). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 3-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. | At Year 3 |
| DFS Rate at 7 Years | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | At Year 7 |
| DFS Rate at 8 Years | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | At Year 8 |
| Overall Survival (OS) Rate at 5 Years | OS was defined as the time from randomization to death due to any cause. 5-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 5 years after randomization was estimated. | At Year 5 |
| OS Rate at 7 Years | OS was defined as the time from randomization to death due to any cause. 7-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | At Year 7 |
| OS Rate at 8 Years | OS was defined as the time from randomization to death due to any cause. 8-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | At Year 8 |
| Distant Recurrence-free Interval (DRFI) Rate at 3 Years | DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. | At Year 3 |
| DRFI Rate at 7 Years | DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 7-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | At Year 7 |
| DRFI Rate at 8 Years | DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 8-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | At Year 8 |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AE can therefore be any unfavorable & unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of a medicinal product, whether or not considered related to medicinal product. SAE=any AE that met any given criteria: fatal (i.e. AE causes/leads to death); life-threatening (i.e. AE, in view of investigator, placed the participant at immediate risk of death); required/prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e. AE results in substantial disruption of participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in investigator's judgment. Percentages have been rounded off. | From signing of informed consent till end of follow up (up to approximately 131 months) |
| Percentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review Committee | Cardiac events were defined as death from cardiac cause or severe congestive heart failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10 percentage points or more from baseline to an LVEF of < 50%. Other cardiac-related events (e.g., any symptomatic congestive heart failure [CHF] associated with a 10% drop in LVEF to < 50%; asymptomatic declines in LVEF requiring dose delay) were summarized as adjudicated by the Cardiac Review Committee. Percentages have been rounded off. | Up to approximately 126 months |
| Percentage of Participants With Hepatotoxicity Events as Adjudicated by the Hepatic Review Committee | Hepatotoxicity events were summarized by treatment arm. Hepatotoxicity events were assessed using liver function laboratory test (LFT) results which included the analysis of baseline and post-baseline levels of alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBILI), and alkaline phosphatase (ALK). Hepatic events, as adjudicated by the Hepatic Review Committee, are summarized. Percentages have been rounded off. | Up to approximately 64 months |
| Number of Participants Who Discontinued Treatment Due to AEs | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were treated for up to 14 cycles (1 cycle = 21 days). | Up to approximately 9.6 months |
| Number of Participants With AEs and SAEs Leading to Death | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that met any of the following criteria: fatal (i.e., the AE actually causes or leads to death); life-threatening (i.e., the AE, in the view of the investigator, placed the participant at immediate risk of death); required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e., the AE results in substantial disruption of the participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in the investigator's judgment. | From signing of informed consent till end of follow up (up to approximately 131 months) |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), a global health status/quality of life (GHS/QoL) scale, three symptom scales (fatigue, pain, nausea, and vomiting), five single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and a perceived financial impact of the disease item. Most questions used a 4-point scale (1= Not at all to 4 = Very much; 2 questions used a 7-point scale [1 = very poor to 7 = Excellent]). Obtained scores are linearly transformed to a score range of 0-100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms. A positive change from baseline indicates improvement. | Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days) |
| Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23) | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Obtained scores are linearly transformed to a score range of 0-100. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in QOL and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in QOL and negative change from baseline indicated a deterioration in QOL. | Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days) |
| Serum Concentrations of Trastuzumab Emtansine | Pre-infusion on Cycles 1, 2, 4 and 5; 15-30 minutes and 2 hours post-infusion on Cycles 1 and 4; treatment discontinuation/completion visit (up to approximately 64 months) (1 cycle = 21 days) |
| Plasma Concentrations of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1) | Concentration of DM1 in plasma was measured through the samples obtained from participants randomized to the trastuzumab emtansine arm. DM1 is an ant-microtubule agent derived from maytansine. In transtuzumab entansine, DM1 is linked to the antibody transtuzumab thus helping the drug to specifically target the HER 2- positive cancer cells. | Pre-infusion, 15-30 minutes and 2 hour post-infusion on Cycles 1 and 4 (1 cycle = 21 days) |
| Serum Concentrations of Trastuzumab | Pre-infusion and 15-30 minutes post-infusion on Cycles 1 and 4; Treatment completion/discontinuation visit (up to approximately 64 months) (1 cycle = 21 days) |
| Serum Concentrations of Total Trastuzumab | Total trastuzumab is the sum of conjugated and unconjugated trastuzumab. Blood and serum samples were obtained from participants randomized to the trastuzumab arm. | Pre-infusion on Day 1 of Cycles 1, 2, 4, and 5; 15-30 minutes and 2 hours post-infusion on Day 1 of Cycles 1 and 4 (1 cycle = 21 days) |
| Median Duration of Trastuzumab Emtansine Exposure | Treatment duration was defined as the time between the first and the last infusion of trastuzumab emtansine. | Up to 12 months |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) to Trastuzumab Emtansine | ADA-positive participants after drug administration were determined for participants exposed to trastuzumab emtansine. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab emtansine was determined by summing the ADA-positive participants across all timepoints. | Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months]) |
| Number of Participants With Positive ADAs to Trastuzumab | ADA-positive participants after drug administration were determined for participants exposed to trastuzumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab was determined by summing the ADA-positive participants across all timepoints. | Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months]) |
| At Year 7 |
| IDFS Rate at 8 Years | IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 8-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 8 years after randomization was estimated. | At Year 8 |
| Long Beach |
| California |
| 90806 |
| United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| Kaiser Permanente - San Diego | San Diego | California | 92120 | United States |
| Breastlink Medical Group Inc | Santa Ana | California | 92705 | United States |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | United States |
| Kaiser Permanente - Franklin | Denver | Colorado | 80205 | United States |
| Colorado Cancer Research Program/Admin | Denver | Colorado | 80222 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06510-3221 | United States |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| UF Health Orlando | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612-9497 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Edward Cancer Center Naperville | Naperville | Illinois | 60540 | United States |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| Norton Healthcare Inc. | Louisville | Kentucky | 40202 | United States |
| Cancer Care of Maine | Brewer | Maine | 04412 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Med Star Franklin Square Medical Center/Weinburg Cancer Institute | Baltimore | Maryland | 21237 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | United States |
| Breslin Cancer Center | Lansing | Michigan | 48910 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| US oncology research at Minnesota Oncology | Saint Louis Park | Minnesota | 55426 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Sparta Cancer Center | Sparta | New Jersey | 07871-1791 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Troy Cancer Treatment Program | Troy | New York | 12180 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204-2839 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122-9988 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University, Arthur James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Kimmel Cancer Center Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| Uni of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916-2305 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital Outpatient Center | Houston | Texas | 77030 | United States |
| Uni of Texas - Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | United States |
| Hematology Oncology Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | 22408 | United States |
| Centra Alan B. Pearson Regional Cancer Center | Lynchburg | Virginia | 24501 | United States |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Swedish Cancer Institute - Issaquah | Issaquah | Washington | 98029 | United States |
| Cancer Care Northwest | Spokane | Washington | 99204 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina |
| Instituto de Oncología de Rosario | Rosario | S2000KZE | Argentina |
| Tiroler Landeskrankenanstalten Ges.M.B.H. | Innsbruck | 6020 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg | Salzburg | 5020 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| AZ Sint Lucas (Sint Lucas) | Ghent | 9000 | Belgium |
| CHU de Liège (Sart Tilman) | Liège | 4000 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| Iop Instituto de Oncologia Do Parana | Curitiba | Paraná | 80530-010 | Brazil |
| UPCO - Unidade de Pesquisas Clínicas em Oncologia | Pelotas | Rio Grande do Sul | 96015-280 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto de Ensino e Pesquisa Sao Lucas - IEP | São Paulo | São Paulo | 01236-030 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Instituto Nacional de Cancer - INCa | Rio de Janeiro | 20560-120 | Brazil |
| Clinicas Oncologicas Integradas - COI | Rio de Janeiro | 22290-160 | Brazil |
| Arthur J.E. Child Comprehensive Cancer Center | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| BC Cancer ? Surrey | Surrey | British Columbia | V3V 1Z2 | Canada |
| British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| CSSS champlain - Charles-Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Centre Hospitalier de l?Université de Montréal (CHUM) | Montreal | Quebec | H2X 3E4 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre - Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Hopital du Saint Sacrement | Québec | Quebec | G1J 1Z4 | Canada |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Guangdong General Hospital | Guangzhou | 510080 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) | Shanghai | 200025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Clinica del Country | Bogotá | 11001 | Colombia |
| Hospital Pablo Tobon Uribe | Medellin-Antioquia | Colombia |
| Oncomedica S.A. | Montería | Colombia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Hopital Jean Minjoz | Besançon | 25030 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Hospitalier Fleyriat | Bourg-en-Bresse | 01012 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre de Cancerologie de la Sarthe, Clinique Victor HugoSoReCOH | Le Mans | 72000 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Centre Val Aurelle Paul Lamarque | Montpellier | 34298 | France |
| Institut Curie | Paris | 75231 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Hopital Tenon | Paris | 75970 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Rene Huguenin | Saint-Cloud | 92210 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Hämatologie Onkologie im Zentrum MVZ GmbH | Augsburg | 86150 | Germany |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Studienzentrum Berlin City | Berlin | 14169 | Germany |
| Onkologische Schwerpunktpraxis Bielefeld | Bielefeld | 33604 | Germany |
| Klinikum Sindelfingen-Böblingen | Böblingen | 71032 | Germany |
| St. Elisabeth Krankenhaus Köln GmbH | Cologne | 50935 | Germany |
| Kliniken der Stadt Köln gGmbH Krankenhaus Holweide | Cologne | 51067 | Germany |
| St. Johannes-Hospital | Dortmund | 44137 | Germany |
| Luisenkrankenhaus GmbH & Co. KG., Brustzentrum | Düsseldorf | 40235 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen | Essen | 45122 | Germany |
| Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH | Essen | 45136 | Germany |
| Klinikum Esslingen | Esslingen am Neckar | 73730 | Germany |
| Klinik Johann Wolfgang von Goethe Uni | Frankfurt | 60596 | Germany |
| Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus | Frankfurt am Main | 60389 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Evangelische Kliniken Gelsenkirchen GmbH | Gelsenkirchen | 45879 | Germany |
| Universitätsklinikum Greifswald | Greifswald | 17475 | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06097 | Germany |
| Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe | Halle | 06110 | Germany |
| Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem | Hamburg | 20357 | Germany |
| St. Barbara-Klinik Hamm-Heessen GmbH | Hamm | 59073 | Germany |
| Diakovere Henriettenstift, Frauenklinik | Hanover | 30559 | Germany |
| Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe | Hanover | 30625 | Germany |
| Nationales Centrum für Tumorerkrankungen (NCT) | Heidelberg | 69120 | Germany |
| Elisabeth-Krankenhaus Brustzentrum | Kassel | 34117 | Germany |
| Klinikum Kassel GmbH | Kassel | 34125 | Germany |
| UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe | Kiel | 24105 | Germany |
| Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel | Lebach | 66822 | Germany |
| Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare) | Lichtenberg | 10367 | Germany |
| Klinikum der Universität München | München | 80337 | Germany |
| Medizinisches Zentrum für Hämatologie und Onkologie | München | 80639 | Germany |
| MVZ Nordhausen gGmbH, Praxis Dr. Grafe | Nordhausen | 99734 | Germany |
| Sana Klinikum Offenbach GmbH | Offenbach | 63069 | Germany |
| St. Vincenz-Krankenhaus Paderborn | Paderborn | 33098 | Germany |
| Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie | Recklinghausen | 45659 | Germany |
| Klinikum am Steinenberg Frauenklinik | Reutlingen | 72764 | Germany |
| Universitätsfrauen- und Poliklinik am Klinikum Suedstadt | Rostock | 18059 | Germany |
| Gynäkologie Kompetenzzentrum | Stralsund | 18439 | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | 70376 | Germany |
| Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung | Traunstein | 83278 | Germany |
| Universitätsklinik Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm Am Michelsberg | Ulm | 89075 | Germany |
| HELIOS Dr. Horst Schmidt Kliniken Wiesbaden | Wiesbaden | 65199 | Germany |
| Marien-Hospital Witten | Witten | 58452 | Germany |
| Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker | Würzburg | 97080 | Germany |
| Univ General Hosp Heraklion | Heraklion | 71110 | Greece |
| Euromedical General Clinic of Thessaloniki | Thessaloniki | 54645 | Greece |
| Centro Oncológico Sixtino / Centro Oncológico SA | Guatemala City | 01009 | Guatemala |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Queen Mary Hospital | Hong Kong | 852 | Hong Kong |
| Tuen Mun Hospital | Hong Kong | 852 | Hong Kong |
| Pamela Youde Nethersole Eastern Hospital | Hong Kong | Hong Kong |
| Cork Uni Hospital | Cork | Ireland |
| St Vincent'S Uni Hospital | Dublin | 4 | Ireland |
| Mater Misericordiae Uni Hospital | Dublin | 7 | Ireland |
| Beaumont Hospital | Dublin | 9 | Ireland |
| Galway Uni Hospital | Galway | Ireland |
| University Hospital Limerick - Oncology | Limerick | Ireland |
| Soroka Medical Center | Beersheba | 8410101 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Rabin MC | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Ospedale Antonio Perrino | Brindisi | Apulia | 72100 | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Università degli Studi Federico II | Naples | Campania | 80131 | Italy |
| Policlinico S.Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Ausl Di Bologna-Ospedale Bellaria | Bologna | Emilia-Romagna | 40139 | Italy |
| Policlinico Universitario Campus Biomedico | Rome | Lazio | 00128 | Italy |
| Az. Osp. Sant'Andrea | Rome | Lazio | 00189 | Italy |
| IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST) | Genoa | Liguria | 16132 | Italy |
| Asst Papa Giovanni XXIII | Bergamo | Lombardy | 24127 | Italy |
| Asst Di Cremona | Cremona | Lombardy | 26100 | Italy |
| Irccs Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int) | Milan | Lombardy | 20133 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Asst Di Monza | Monza | Lombardy | 20052 | Italy |
| Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo | Candiolo | Piedmont | 10060 | Italy |
| Azlenda Ospendaliero-Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| Azienda usl 5 Di Pisa-Ospedale Di Pontedera | Pontedera | Tuscany | 56025 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS | Padova | Veneto | 35128 | Italy |
| A.O.U.I. Verona-Ospedale Borgo Trento | Verona | Veneto | 37126 | Italy |
| Hospital Angeles Metropolitano | Mexico City | Mexico CITY (federal District) | 06760 | Mexico |
| Médicos Especialistas en Cáncer SC | Aguascalientes | 20230 | Mexico |
| Instituto Nacional de Cancerologia | Distrito Federal | 14080 | Mexico |
| Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir | Mexico City | 14080 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| The Panama Clinic | Panama City | 0832 | Panama |
| Centro Oncologico America | Panama City | 0834-02723 | Panama |
| Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud | Arequipa | 04001 | Peru |
| Centro Medico Monte Carmelo | Arequipa | Peru |
| Hospital IV Alberto Sabogal Sologuren | Bellavista | Callao 2 | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen | Lima | 13 | Peru |
| Clinica San Borja | Lima | Lima 41 | Peru |
| Institute for Oncology and Radiology of Serbia | Belgrade | 11000 | Serbia |
| Oncology Institute of Vojvodina | Kamenitz | 21204 | Serbia |
| Cape Town Oncology Trials | Cape Town | 7570 | South Africa |
| Medical Oncology Centre of Rosebank | Johannesburg | 2196 | South Africa |
| Wits Donald Gordon Clinical Trial Centre | Parktown | South Africa |
| Hopelands Cancer Centre | Pietermaritzburg | 3201 | South Africa |
| Cancercare | Port Elizabeth | 6045 | South Africa |
| Private Oncology Centre | Pretoria | 0081 | South Africa |
| Hospital de Donostia | Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Hospital Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| Hospital de Navarra | Navarra | Navarre | 31008 | Spain |
| Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitari Sant Joan de Reus | Reus | Tarragona | 43204 | Spain |
| Hospital Clínic i Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Instituto Valenciano Oncologia | Valencia | 46009 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Gävle Sjukhus | Gävle | 801 87 | Sweden |
| Skånes University Hospital, Skånes Department of Onclology | Lund | 22185 | Sweden |
| Karolinska Hospital | Stockholm | 17176 | Sweden |
| Kantonsspital Aarau AG Medizin Onkologie | Aarau | 5001 | Switzerland |
| Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich | Zurich | 8008 | Switzerland |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| Veterans General Hospital | Taipei | 00112 | Taiwan |
| National Taiwan Uni Hospital | Taipei | 100 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Chang Gung Medical Foundation - Linkou | Taoyuan | 333 | Taiwan |
| Uludag Uni Hospital | Bursa | 16059 | Turkey (Türkiye) |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Edirne | 22770 | Turkey (Türkiye) |
| Kartal Dr Lutfi Kirdar Sehir Hastanesi | Istanbul | 34000 | Turkey (Türkiye) |
| Ege Uni Medical Faculty Hospital | Izmir | 35100 | Turkey (Türkiye) |
| Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department | Malatya | 44280 | Turkey (Türkiye) |
| University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Bristol Haematology and Oncology centre | Bristol | BS2 8ED | United Kingdom |
| Castle Hill Hospital | Cottingham | HU16 5JG | United Kingdom |
| North Devon District Hospital | Devon | EX31 4JB | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Huddersfield Royal Infirmary | Huddersfield | HD3 3EA | United Kingdom |
| Leeds Teaching Hosp NHS Trust | Leeds | LS9 7TF | United Kingdom |
| St Thomas Hospital | London | SE1 7EH | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Christie Hospital Nhs Trust | Manchester | M2O 4BX | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Weston Park Hospital | Sheffield | S10 2SJ | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| Derived |
| von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5. |
Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
| Safety-evaluable (SE) Population | SE population included all randomized participants who received any amount of study treatment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants who were randomized to the study regardless of whether they received any study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab | Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
| BG001 | Trastuzumab Emtansine | Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
| 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Invasive Disease-free Survival (IDFS) Rate at 3 Years | IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 3-year IDFS rate in ITT population was estimated using Kaplan Meier (KM) method and the percentage of participants who were event-free 3 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 3 |
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| Other Pre-specified | IDFS Rate at 7 Years | IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 7-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 7 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 7 |
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| Other Pre-specified | IDFS Rate at 8 Years | IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 8-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 8 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 8 |
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| Secondary | IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ [CIS] of any site). IDFS event was defined as outlined in the description for IDFS rate outcome measure (OM) number 1. 3-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 3 |
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| Secondary | IDFS Including SPNBC Rate at 7 Years | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 7 |
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| Secondary | IDFS Including SPNBC Rate at 8 Years | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 8 |
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| Secondary | Disease-free Survival (DFS) Rate at 3 Years | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral ductal carcinoma in situ (DCIS). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 3-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 3 |
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| Secondary | DFS Rate at 7 Years | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 7 |
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| Secondary | DFS Rate at 8 Years | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 8 |
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| Secondary | Overall Survival (OS) Rate at 5 Years | OS was defined as the time from randomization to death due to any cause. 5-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 5 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 5 |
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| Secondary | OS Rate at 7 Years | OS was defined as the time from randomization to death due to any cause. 7-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 7 |
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| Secondary | OS Rate at 8 Years | OS was defined as the time from randomization to death due to any cause. 8-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 8 |
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| Secondary | Distant Recurrence-free Interval (DRFI) Rate at 3 Years | DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 3 |
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| Secondary | DRFI Rate at 7 Years | DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 7-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 7 |
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| Secondary | DRFI Rate at 8 Years | DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 8-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 8 |
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| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AE can therefore be any unfavorable & unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of a medicinal product, whether or not considered related to medicinal product. SAE=any AE that met any given criteria: fatal (i.e. AE causes/leads to death); life-threatening (i.e. AE, in view of investigator, placed the participant at immediate risk of death); required/prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e. AE results in substantial disruption of participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in investigator's judgment. Percentages have been rounded off. | SE population included all randomized participants who received any amount of study treatment. | Posted | Number | percentage of participants | From signing of informed consent till end of follow up (up to approximately 131 months) |
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| Secondary | Percentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review Committee | Cardiac events were defined as death from cardiac cause or severe congestive heart failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10 percentage points or more from baseline to an LVEF of < 50%. Other cardiac-related events (e.g., any symptomatic congestive heart failure [CHF] associated with a 10% drop in LVEF to < 50%; asymptomatic declines in LVEF requiring dose delay) were summarized as adjudicated by the Cardiac Review Committee. Percentages have been rounded off. | SE population included all randomized participants who received any amount of study treatment. | Posted | Number | percentage of participants | Up to approximately 126 months |
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| Secondary | Percentage of Participants With Hepatotoxicity Events as Adjudicated by the Hepatic Review Committee | Hepatotoxicity events were summarized by treatment arm. Hepatotoxicity events were assessed using liver function laboratory test (LFT) results which included the analysis of baseline and post-baseline levels of alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBILI), and alkaline phosphatase (ALK). Hepatic events, as adjudicated by the Hepatic Review Committee, are summarized. Percentages have been rounded off. | SE population included all randomized participants who received any amount of study treatment. | Posted | Number | percentage of participants | Up to approximately 64 months |
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| Secondary | Number of Participants Who Discontinued Treatment Due to AEs | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were treated for up to 14 cycles (1 cycle = 21 days). | SE population included all randomized participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Up to approximately 9.6 months |
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| Secondary | Number of Participants With AEs and SAEs Leading to Death | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that met any of the following criteria: fatal (i.e., the AE actually causes or leads to death); life-threatening (i.e., the AE, in the view of the investigator, placed the participant at immediate risk of death); required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e., the AE results in substantial disruption of the participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in the investigator's judgment. | SE population included all randomized participants who received any amount of study treatment. | Posted | Count of Participants | Participants | From signing of informed consent till end of follow up (up to approximately 131 months) |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) | The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), a global health status/quality of life (GHS/QoL) scale, three symptom scales (fatigue, pain, nausea, and vomiting), five single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and a perceived financial impact of the disease item. Most questions used a 4-point scale (1= Not at all to 4 = Very much; 2 questions used a 7-point scale [1 = very poor to 7 = Excellent]). Obtained scores are linearly transformed to a score range of 0-100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms. A positive change from baseline indicates improvement. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days) |
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| Secondary | Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23) | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Obtained scores are linearly transformed to a score range of 0-100. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in QOL and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in QOL and negative change from baseline indicated a deterioration in QOL. | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days) |
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| Secondary | Serum Concentrations of Trastuzumab Emtansine | Pharmacokinetic (PK)-evaluable population included all participants who received at least 1 dose of trastuzumab emtansine and had at least one evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | Pre-infusion on Cycles 1, 2, 4 and 5; 15-30 minutes and 2 hours post-infusion on Cycles 1 and 4; treatment discontinuation/completion visit (up to approximately 64 months) (1 cycle = 21 days) |
|
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| Secondary | Plasma Concentrations of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1) | Concentration of DM1 in plasma was measured through the samples obtained from participants randomized to the trastuzumab emtansine arm. DM1 is an ant-microtubule agent derived from maytansine. In transtuzumab entansine, DM1 is linked to the antibody transtuzumab thus helping the drug to specifically target the HER 2- positive cancer cells. | PK-evaluable population included all participants who received atleast 1 dose of trastuzumab emtansine and had at least one evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-infusion, 15-30 minutes and 2 hour post-infusion on Cycles 1 and 4 (1 cycle = 21 days) |
|
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| Secondary | Serum Concentrations of Trastuzumab | PK-evaluable population included all participants who received at least 1 dose of trastuzumab and had at least one evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Pre-infusion and 15-30 minutes post-infusion on Cycles 1 and 4; Treatment completion/discontinuation visit (up to approximately 64 months) (1 cycle = 21 days) |
|
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| Secondary | Serum Concentrations of Total Trastuzumab | Total trastuzumab is the sum of conjugated and unconjugated trastuzumab. Blood and serum samples were obtained from participants randomized to the trastuzumab arm. | PK-evaluable population included all participants who received at least 1 dose of trastuzumab and had at least one evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Pre-infusion on Day 1 of Cycles 1, 2, 4, and 5; 15-30 minutes and 2 hours post-infusion on Day 1 of Cycles 1 and 4 (1 cycle = 21 days) |
|
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| Secondary | Median Duration of Trastuzumab Emtansine Exposure | Treatment duration was defined as the time between the first and the last infusion of trastuzumab emtansine. | SE population included all randomized participants who received any amount of study treatment. | Posted | Median | Full Range | months | Up to 12 months |
|
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| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) to Trastuzumab Emtansine | ADA-positive participants after drug administration were determined for participants exposed to trastuzumab emtansine. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab emtansine was determined by summing the ADA-positive participants across all timepoints. | SE Population included all randomized participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Count of Participants | Participants | Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months]) |
|
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| Secondary | Number of Participants With Positive ADAs to Trastuzumab | ADA-positive participants after drug administration were determined for participants exposed to trastuzumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab was determined by summing the ADA-positive participants across all timepoints. | SE Population included all randomized participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Count of Participants | Participants | Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months]) |
|
|
From signing of informed consent till the end of follow-up (up to approximately 131 months)
AE(s): SE Population. All-cause mortality: ITT population.1 participant randomized to trastuzumab arm was untreated, later re-randomized to T-DM1 arm & received treatment. Another participant in trastuzumab arm received 13 cycles of trastuzumab & 1 of T-DM1. Both these participants were included in the trastuzumab ITT population & T-DM1 safety analysis (SA). 1 participant in T-DM1 arm received 9 cycles of trastuzumab & included in trastuzumab SA.
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 | Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. | 126 | 743 | 58 | 720 | 633 | 720 |
| EG001 | Trastuzumab Emtansine | Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. | 94 | 743 | 94 | 740 | 719 | 740 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ILEAL PERFORATION | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| GALLBLADDER POLYP | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HEPATIC CYST | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| NODULAR REGENERATIVE HYPERPLASIA | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ABSCESS INTESTINAL | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| IMPLANT SITE CELLULITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| INFECTED SEROMA | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| MASTITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| VESTIBULAR NEURONITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| VULVITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| RADIATION PNEUMONITIS | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| ULNA FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| TROPONIN T INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COLON CANCER STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| ENDOMETRIAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| INTRADUCTAL PROLIFERATIVE BREAST LESION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| PITUITARY TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| BLADDER PAIN | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HEAVY MENSTRUAL BLEEDING | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| UTERINE OBSTRUCTION | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| UTERINE PROLAPSE | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| TELANGIECTASIA | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA 27.0 | 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 |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2023 | May 22, 2025 | SAP_003.pdf |
| 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 |
|---|---|
| D000068878 | Trastuzumab |
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units |
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| Counts |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
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| Units | Counts |
|---|
| Participants |
|
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| Participants |
|
|
| Participants |
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Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
|
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| OG001 | Trastuzumab Emtansine | Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
|
|
| OG001 | Trastuzumab Emtansine | Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. |
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| Counts |
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| Participants |
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| Participants |
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