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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004024-29 | EudraCT Number |
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This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and Paclitaxel | Placebo Comparator | Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. |
|
| Atezolizumab and Paclitaxel | Experimental | Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody | Drug | Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) |
| Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the PD-L1-Positive Subpopulation | OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis. | From Day 1 to death from any cause, assessed up 36 months |
| Overall Survival (OS) in the ITT Population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94305-5820 | United States | ||
| Florida Cancer Specialists; Department of Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34219000 | Derived | Miles D, Gligorov J, Andre F, Cameron D, Schneeweiss A, Barrios C, Xu B, Wardley A, Kaen D, Andrade L, Semiglazov V, Reinisch M, Patel S, Patre M, Morales L, Patel SL, Kaul M, Barata T, O'Shaughnessy J; IMpassion131 investigators. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994-1004. doi: 10.1016/j.annonc.2021.05.801. Epub 2021 Jul 1. |
| Label | URL |
|---|---|
| Additional information for the IMpassion131 | View source |
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The target population included subjects with previously untreated inoperable locally advanced or metastatic TNBC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Paclitaxel | Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. |
| FG001 |
| 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 | Feb 11, 2020 | Nov 10, 2020 |
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The Sponsor and its agents; the study site personnel, including the investigator; and the participant will be blinded to treatment assignment.
|
| Atezolizumab Placebo | Drug | Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle. |
|
| Paclitaxel | Drug | Paclitaxel will be administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle. |
|
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis. |
| From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months) |
| Percentage of Participants Who Are Alive at 12 and 18 Months | From Day 1 to death from any cause, assessed up to 12 and 18 months |
| Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population | Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms. | From Day 1 to deterioration, assessed up 64 months |
| Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1 | PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | From Day 1 to PD or death from any cause, assessed up to 12 months |
| Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed ) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed ) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed ) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed) | DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | From objective response to PD, assessed up to primary completion date (approximately 26 months) |
| Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population | Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started. | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population | Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months). |
| Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population | C1D1 30 min postdose |
| Minimum Observed Plasma Concentration (Cmin) of Paclitaxel | Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days) |
| Maximum Observed Plasma Concentration (Cmax) of Paclitaxel | Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days) |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Investigator text for AEs is coded using MedDRA version 25.1 | From Day 1 From baseline up to 64 months |
| Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days) |
| Overall Survival by PD-L1 Status, Intent to Treat Population | From Day 1 up to 66 months |
| Progression Free Survival by PD-L1 Status, Intent to Treat Population | From Day 1 up to primary completion date (approximately 26 months) |
| Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population | C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. | From objective response to PD, assessed up to primary completion date (approximately 26 months) |
| Fort Myers |
| Florida |
| 33901-8101 |
| United States |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| HCA Midwest Health | Kansas City | Missouri | 64132 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| Magee-Woman's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Tennessee Oncology; Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina |
| Centro de Pesquisas Clinicas em Oncologia - CPCO | Cachoeiro de Itapemirim | Espírito Santo | 29308-014 | Brazil |
| Santa Casa de Misericordia de Salvador | Salvador | Estado de Bahia | 40050-410 | Brazil |
| Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiânia | Goiás | 74605-070 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 90040-373 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Tom Baker Cancer Centre-Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Grand River Hospital | Kitchener | Ontario | N2G 1G3 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| McGill University; Glen Site; Oncology | Montreal | Quebec | H4A 3J1 | Canada |
| Hopital du Saint Sacrement | Québec | Quebec | G1S 4L8 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China |
| Beijing Union Hospital | Beijing | 100730 | China |
| West China Hospital, Sichuan University; Department of Breast | Chengdu | 610041 | China |
| Sun Yat-sen Memorial Hospital | Guangzhou | 510000 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing | 210029 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) | Shanghai | 200025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Liaoning cancer Hospital & Institute | Shenyang | 110042 | China |
| Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province) | Shijiazhuang | 050035 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | 3000060 | China |
| The Second Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | 710004 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU | Ostrava-Poruba | 70852 | Czechia |
| Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika | Prague | 128 08 | Czechia |
| Clinique Sainte Catherine; Hopital De Semaine | Avignon | 84918 | France |
| HOPITAL JEAN MINJOZ; Oncologie | Besançon | 25030 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33300 | France |
| Hopital Morvan | Brest | 29200 | France |
| CHD Les Oudairies | La Roche-sur-Yon | 85925 | France |
| Centre Oscar Lambret; Senologie | Lille | 59020 | France |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Hopital Caremeau; Hematologie Oncologie | Nîmes | 30029 | France |
| Hopital Tenon | Paris | 75020 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| Hopital Saint Louis, Service D Oncologie Medicale | Paris | 75475 | France |
| Ch Pitie Salpetriere; Oncologie Medicale | Paris | 75651 | France |
| Centre Eugene Marquis; Service d'oncologie | Rennes | 35042 | France |
| Centre Paul Strauss; Oncologie Medicale | Strasbourg | 67065 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Institut Gustave Roussy; Sitep | Villejuif | 94805 | France |
| Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters | Berlin | 13581 | Germany |
| Onkologische Schwerpunktpraxis Bielefeld | Bielefeld | 33604 | Germany |
| St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe | Cologne | 50935 | Germany |
| Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum | Essen | 45136 | Germany |
| HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg | Hamburg | 22767 | Germany |
| Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde | Mainz | 55131 | Germany |
| OnkoNet Marburg GmbH | Marburg | 35037 | Germany |
| Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt | München | 80336 | Germany |
| Gemeinschaftspraxis für Hämatologie und Onkologie | Münster | 48153 | Germany |
| Klinikum Ernst von Bergmann; Frauenklinik | Potsdam | 14467 | Germany |
| Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis | Troisdorf | 53840 | Germany |
| Universitätsklinik Tübingen; Frauenklinik | Tübingen | 72076 | Germany |
| Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine | Athens | 115 22 | Greece |
| ARETAIEION UNIVERSITY HOSPITAL; oncology unit | Athens | 115 28 | Greece |
| Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept. | Kifissia | 145 64 | Greece |
| Papageorgiou General Hospital; Medical Oncology | Thessaloniki | 564 29 | Greece |
| Yashoda Hospital | Hyderabad | Andhra Pradesh | 500082 | India |
| Manipal Hospital; Department of Oncology | Bangalore | Karnataka | 560017 | India |
| Tata Memorial Hospital; Dept of Medical Oncology | Mumbai | Maharashtra | 400012 | India |
| Jehangir Hospital | Pune | Maharashtra | 411001 | India |
| Dr. B L Kapur Memorial Hospital; BLK Cancer Centre | New Delhi | National Capital Territory of Delhi | 110005 | India |
| Indraprastha Apollo Hospitals | New Delhi | National Capital Territory of Delhi | 110076 | India |
| Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology | New Delhi | National Capital Territory of Delhi | 110085 | India |
| Max Super Speciality Hospital; Medical Oncology | North WEST Delhi | National Capital Territory of Delhi | 110088 | India |
| Apollo Speciality Hospital | Chennai | Tamil Nadu | 600035 | India |
| Apollo Gleneagles Hospitals | Kolkata | West Bengal | 700054 | India |
| TATA Medical Centre; Medical Oncology | Kolkata | West Bengal | 700156 | India |
| MAX Balaji Hospital | Delhi | 1100092 | India |
| Hadassah Ein Karem Hospital; Oncology Dept | Jerusalem | 9112000 | Israel |
| Rabin MC; Davidof Center - Oncology Institute | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center | Ramat Gan | 5262100 | Israel |
| Rambam Health Corporation; Oncology Institute | Rambam | 3525408 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Tel Aviv Sourasky Medical Ctr; Oncology | Tel Aviv | 6423906 | Israel |
| Assaf Harofeh; Oncology | Ẕerifin | 6093000 | Israel |
| Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI) | Chieti | Abruzzo | 66103 | Italy |
| Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia | Frattamaggiore | Campania | 80027 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | Campania | 80131 | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero - Universitaria di Modena Policlinico | Modena | Emilia-Romagna | 41110 | Italy |
| Universita Campus Bio-Medico di Roma (UCBM) | Rome | Lazio | 00128 | Italy |
| IRCCS Istituto Regina Elena (IFO); Oncologia Medica B | Rome | Lazio | 00144 | Italy |
| Azienda Policlinico Umberto I | Rome | Lazio | 00161 | Italy |
| A.O. Universitaria S. Martino Di Genova | Genoa | Liguria | 16132 | Italy |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) | Bergamo | Lombardy | 24127 | Italy |
| Asst Degli Spedali Civili Di Brescia | Brescia | Lombardy | 25123 | Italy |
| Hospital San Raffaele | Milan | Lombardy | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica | Milan | Lombardy | 20141 | Italy |
| IRCCS Istituto Clinico Humanitas; Oncologia | Rozzano (MI) | Lombardy | 20089 | Italy |
| Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo | Candiolo | Piedmont | 10060 | Italy |
| Ospedale S. Vincenzo; Oncologia Medica | Taormina | Sicily | 98030 | Italy |
| Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Florence | Tuscany | 50134 | Italy |
| Ospedale Civile; Unita Operativa Di Oncologia Medica | Livorno | Tuscany | 57100 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II | Padova | Veneto | 35128 | Italy |
| Gunma Prefectural Cancer Center | Gunma | 373-8550 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Kanagawa Cancer Center | Kanagawa | 241-8515 | Japan |
| Tokai University Hospital | Kanagawa | 259-1193 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Naha-nishi Clinic | Okinawa | 901-0154 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Saitama Cancer Center | Saitama | 362-0806 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie | Marrakesh | 40000 | Morocco |
| Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie | Rabat | 10000 | Morocco |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Centrul de Oncologie Sfantul Nectarie | Craiova | 200347 | Romania |
| Russian Oncology Research Center n.a. N.N. Blokhin | Moscow | Moscow Oblast | 115478 | Russia |
| Petrov Research Inst. of Oncology | Saint Petersburg | 197758 | Russia |
| King Fahad Specialist Hospital; Oncology | Dammam | 31444 | Saudi Arabia |
| International Medical Center (IMC) | Jeddah | 21451 | Saudi Arabia |
| King Fahad Medical City; Gastroentrology | Riyadh | 11525 | Saudi Arabia |
| Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A | Bratislava | 833 10 | Slovakia |
| POKO Poprad; Department of Oncology | Poprad | 058 01 | Slovakia |
| Wilgers Oncology Centre | Pretoria | 0001 | South Africa |
| Private Oncology Centre | Pretoria | 0081 | South Africa |
| Sandton Oncology Medical Group | Sandton | 2196 | South Africa |
| Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | 08036 | Spain |
| Hospital Universitario de Fuenlabrada; Servicio de Oncologia | Madrid | 28943 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Oncologia | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Adana Baskent University Medical Faculty; Oncology | Adana | 01220 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Ankara | 06490 | Turkey (Türkiye) |
| Uludag University Medical Faculty; Internal Medicine | Bursa | 16059 | Turkey (Türkiye) |
| Dicle Uni Medical Faculty; Internal Medicine | Diyarbakır | 10000 | Turkey (Türkiye) |
| Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne | 22030 | Turkey (Türkiye) |
| Izmir Ataturk Training and Research Hospital | Izmir | 35965 | Turkey (Türkiye) |
| Kocaeli University Faculty of Medicine; Medical oncology | İzmit | 31380 | Turkey (Türkiye) |
| Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology | Kadiköy | 34722 | Turkey (Türkiye) |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | SE1 9RT | United Kingdom |
| Christie Hospital | Manchester | M20 3BG | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | HA6 2RN | United Kingdom |
| K hospital | Hanoi | 100000 | Vietnam |
| Hochiminh city oncology hospital | Hochiminh City | 700000 | Vietnam |
| general information on clinical trials | View source |
| Atezolizumab + Paclitaxel |
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo and Paclitaxel | Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. |
| BG001 | Atezolizumab and Paclitaxel | Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. |
| 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Posted | Median | 95% Confidence Interval | Months | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) |
|
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| Primary | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | ITT population: all randomized participants, whether or not the assigned study treatment was received | Posted | Median | 95% Confidence Interval | Months | From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) |
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| Secondary | Overall Survival (OS) in the PD-L1-Positive Subpopulation | OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis. | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Posted | Median | 95% Confidence Interval | Months | From Day 1 to death from any cause, assessed up 36 months |
|
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| Secondary | Overall Survival (OS) in the ITT Population | OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis. | ITT population: all randomized participants, whether or not the assigned study treatment was received | Posted | Median | 95% Confidence Interval | Months | From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months) |
|
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| Secondary | Percentage of Participants Who Are Alive at 12 and 18 Months | ITT population: all randomized participants, whether or not the assigned study treatment was received | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to death from any cause, assessed up to 12 and 18 months |
|
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| Secondary | Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population | Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms. | PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer [EORTC] Quality-of-life Questionnaire [QLQ] C30, EORTC QLQ BR-23 or FACT-G) | Posted | Median | 95% Confidence Interval | Months | From Day 1 to deterioration, assessed up 64 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1 | PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | ITT population: all randomized participants, whether or not the assigned study treatment was received | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to PD or death from any cause, assessed up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed ) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
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| Secondary | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. | PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed ) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. | Response-evaluable population: participants in the ITT population with measurable disease at baseline | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed ) | Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. | Response-evaluable population: participants in the ITT population with measurable disease at baseline | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed) | DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. | Duration of response (DoR)-evaluable population: participants in the ITT population with measurable disease at baseline | Posted | Median | 95% Confidence Interval | Months | From objective response to PD, assessed up to primary completion date (approximately 26 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population | Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started. | Clinical Benefit Rate analysis included all participants with unconfirmed PR/CR or SD of at least 6 months duration | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to PD, assessed up to primary completion date (approximately 26 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population | PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months). |
|
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population | PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Posted | Mean | Standard Deviation | μg/mL | C1D1 30 min postdose |
|
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| Secondary | Minimum Observed Plasma Concentration (Cmin) of Paclitaxel | PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days) |
|
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Paclitaxel | PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days) |
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| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Investigator text for AEs is coded using MedDRA version 25.1 | Safety-evaluable population: participants who received any amount of any study drug. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Posted | Number | Percentage of participants | From Day 1 From baseline up to 64 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population | Anti-Drug Antibody (ADA) population:
For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error. | Posted | Number | Percentage of Participants | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days) |
|
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| Secondary | Overall Survival by PD-L1 Status, Intent to Treat Population | ITT population: all randomized participants, whether or not the assigned study treatment was received | Posted | Median | 95% Confidence Interval | Months | From Day 1 up to 66 months |
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| Secondary | Progression Free Survival by PD-L1 Status, Intent to Treat Population | ITT population: all randomized participants, whether or not the assigned study treatment was received | Posted | Median | 95% Confidence Interval | Months | From Day 1 up to primary completion date (approximately 26 months) |
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| Secondary | Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population | C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later. | Duration of confirmed response (C-DoR)-evaluable population: participants in the ITT population with measurable disease at baseline and with a confirmed objective response | Posted | Median | 95% Confidence Interval | Months | From objective response to PD, assessed up to primary completion date (approximately 26 months) |
|
From baseline up to 64 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezolizumab + Paclitaxel | Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | 229 | 431 | 112 | 431 | 421 | 431 |
| EG001 | Placebo + Paclitaxel | Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | 119 | 220 | 40 | 220 | 209 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BICYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOPHYSITIS | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| KERATITIS | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ORBITAL MYOSITIS | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| GASTROINTESTINAL ULCER | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| IMMUNE-MEDIATED PANCREATITIS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| MYELITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| VESTIBULAR NEURONITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| PROCEDURAL PNEUMOTHORAX | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERAMYLASAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERLIPASAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOPROTEINAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| POLYMYOSITIS | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| CEREBRAL VENOUS SINUS THROMBOSIS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MYASTHENIA GRAVIS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DEVICE BREAKAGE | Product Issues | MedDRA 25.1 | Systematic Assessment |
| |
| DEVICE KINK | Product Issues | MedDRA 25.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| GLOMERULONEPHRITIS CHRONIC | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NEPHRITIS | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MYELOSUPPRESSION | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| VENTRICULAR ARRHYTHMIA | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| AUTOIMMUNE PANCREATITIS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOMANIA | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| EMBOLISM VENOUS | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 25.1 | 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_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2020 | Nov 10, 2020 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.2601 |
| Hazard Ratio (HR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.62 |
| 1.14 |
| Superiority |
|
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| Participants |
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Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
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