A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04191499
Collaborator
(none)
400
229
2
67.7
1.7
0
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Actual Study Start Date
:
Jan 29, 2020
Anticipated Primary Completion Date
:
Sep 19, 2025
Anticipated Study Completion Date
:
Sep 19, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inavolisib + Palbociclib + Fulvestrant Participants will receive inavolisib, palbociclib, and fulvestrant. |
Drug: Inavolisib
Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
Other Names:
Drug: Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Drug: Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
|
| Placebo Comparator: Placebo + Palbociclib + Fulvestrant Participants will receive placebo, palbociclib, and fulvestrant. |
Drug: Placebo
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
Drug: Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Drug: Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years)]
Secondary Outcome Measures
- Objective Response Rate (ORR) [Up to 6 years]
- Best Overall Response Rate (BOR) [Up to 6 years]
- Duration of Response (DOR) [From the first occurrence of a CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years)]
- Clinical Benefit Rate (CBR) [Up to 6 years]
- Overall Survival (OS) [From randomization to death from any cause (up to 6 years)]
- Time to Deterioration (TTD) in Pain [Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)]
- TTD in Physical Function [Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)]
- TTD in Role Function [Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)]
- TTD in Global Health Status [Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)]
- Percentage of Participants with Adverse Events [From randomization through the end of study (up to 6 years)]
- Plasma Concentration of Inavolisib [At pre-defined intervals from baseline to the end of study (up to 6 years)]
- Plasma Concentration of Palbociclib [At pre-defined intervals from baseline to the end of study (up to 6 years)]
- Plasma Concentration of Fulvestrant [At pre-defined intervals from baseline to the end of study (up to 6 years)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria
-
Confirmed diagnosis of HR+/HER2- breast cancer
-
Metastatic or locally advanced disease not amenable to curative therapy
-
Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
-
Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
-
Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
-
Consent to provide fresh or archival tumor tissue specimen
-
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1; "bone-only" disease, even if considered measurable, is not eligible
-
Eastern Cooperative Oncology Group Performance Status of 0 or 1
-
Life expectancy of > 6 months
-
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion Criteria
-
Metaplastic breast cancer
-
Any history of leptomeningeal disease or carcinomatous meningitis
-
Any prior systemic therapy for metastatic breast cancer
-
Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
-
Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
-
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
-
Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases are eligible
-
Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
-
Symptomatic active lung disease, or requiring daily supplemental oxygen
-
History of inflammatory bowel disease or active bowel inflammation
-
Anti-cancer therapy within 2 weeks before study entry
-
Investigational drug(s) within 4 weeks before randomization
-
Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
-
Chronic corticosteroid therapy or immunosuppressants
-
Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
-
Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Oncology Associates, PC-CASA | Tucson | Arizona | United States | 85711 |
| 2 | Beverly Hills Cancer Center | Beverly Hills | California | United States | 90211 |
| 3 | Kaiser Permanente;Clinical Trials Department | Denver | Colorado | United States | 80218 |
| 4 | Norwalk Hospital | Norwalk | Connecticut | United States | 06856 |
| 5 | Florida Cancer Specialists - Fort Myers (Broadway) | Fort Myers | Florida | United States | 33901 |
| 6 | Memorial Healthcare System - Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
| 7 | Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | Saint Petersburg | Florida | United States | 33705 |
| 8 | SCRI Florida Cancer Specialists PAN | Tallahassee | Florida | United States | 32308 |
| 9 | SCRI Florida Cancer Specialists East | West Palm Beach | Florida | United States | 33401 |
| 10 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30329 |
| 11 | Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | United States | 30060 |
| 12 | Univ of Chicago | Chicago | Illinois | United States | 60637 |
| 13 | Maryland Oncology Hematology; Maryland Oncology Hematology, Silver Spring | Silver Spring | Maryland | United States | 20904 |
| 14 | Massachusetts General Hospital. | Boston | Massachusetts | United States | 02114 |
| 15 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 16 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 17 | HCA Midwest Division | Kansas City | Missouri | United States | 64132 |
| 18 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 19 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 20 | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
| 21 | Providence Portland Medical Center; Providence Oncology and Hematology Clinic Westside | Portland | Oregon | United States | 97225 |
| 22 | SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | United States | 37404 |
| 23 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 24 | Texas Onc-Central Austin CA Ct | Austin | Texas | United States | 78731 |
| 25 | Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | United States | 75231 |
| 26 | Texas Tech University Health Sciences Center; Department of Internal Medicine | El Paso | Texas | United States | 79905 |
| 27 | The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | United States | 76104 |
| 28 | Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen | McAllen | Texas | United States | 78503 |
| 29 | Texas Oncology - Northeast Texas | Paris | Texas | United States | 75460 |
| 30 | Texas Oncology-Plano East | Plano | Texas | United States | 75075-7787 |
| 31 | Texas Oncology San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
| 32 | Northwest Medical Specialties | Tacoma | Washington | United States | 98405 |
| 33 | Macquarie University Hospital | Macquarie Park | New South Wales | Australia | 2109 |
| 34 | Westmead Hospital; Medical Oncology and Pallative Care | Westmead | New South Wales | Australia | 2145 |
| 35 | Southern Medical Day Care Centre | Wollongong | New South Wales | Australia | 2500 |
| 36 | Cairns Base Hospital; Cancer Care Centre | Cairns | Queensland | Australia | 4870 |
| 37 | Mater Adult Hospital; Oncology | South Brisbane | Queensland | Australia | 4101 |
| 38 | Townsville Hospital; Haematology and Oncology | Townsville | Queensland | Australia | 4810 |
| 39 | Princess Alexandra Hospital; Cancer Trials Unit | Woolloongabba | Queensland | Australia | 4102 |
| 40 | Western Health | Fitzroy | Victoria | Australia | 3065 |
| 41 | Peninsula and South Eastern Haematology and Oncology Group | Frankston | Victoria | Australia | 3199 |
| 42 | Austin Health; Cancer Clinical Trial Centre | Heidelberg | Victoria | Australia | 3084 |
| 43 | Peter MacCallum Cancer Centre; Medical Oncology | Melbourne | Victoria | Australia | 3000 |
| 44 | Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1 | St. Pölten | Austria | 3100 | |
| 45 | Cliniques Universitaires St-Luc | Bruxelles | Belgium | 1200 | |
| 46 | GHdC Site Notre Dame | Charleroi | Belgium | 6000 | |
| 47 | UZ Antwerpen | Edegem | Belgium | 2650 | |
| 48 | UZ Leuven Gasthuisberg | Leuven | Belgium | 3000 | |
| 49 | Tom Baker Cancer Centre-Calgary | Calgary | Alberta | Canada | T2N 4N2 |
| 50 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 51 | Fraser Valley Centre British Columbia Cancer Agency | Surrey | British Columbia | Canada | V3V 1Z2 |
| 52 | Royal Victoria Hospital | Barrie | Ontario | Canada | L4M 6M2 |
| 53 | London Regional Cancer Program, London Health Sciences Centre, Baines Centre | London | Ontario | Canada | N6A 4L6 |
| 54 | Ottawa Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
| 55 | Princess Margaret Cancer Center | Toronto | Ontario | Canada | M5G 1Z5 |
| 56 | Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 57 | Hopital du Saint Sacrement | Quebec City | Quebec | Canada | G1S 4L8 |
| 58 | Centre Hospitalier Regional De Rimouski | Rimouski | Quebec | Canada | G5L 5T1 |
| 59 | Beijing Cancer Hospital | Beijing | China | 100142 | |
| 60 | The First Hospital of Jilin University | Changchun City | China | 130021 | |
| 61 | West China Hospital, Sichuan University | Chengdu | China | 610041 | |
| 62 | The First Affiliated Hospital, Chongqing Medical University | Chongqing | China | 400016 | |
| 63 | The First People's Hospital of Foshan | Foshan | China | 510000 | |
| 64 | Fujian Medical University Union Hospital | Fuzhou City | China | 350001 | |
| 65 | Sun Yet-sen University Cancer Center | Guangzhou | China | 510060 | |
| 66 | Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department | Hangzhou City | China | 310022 | |
| 67 | Harbin Medical University Cancer Hospital | Harbin | China | 150081 | |
| 68 | Anhui Provincial Hospital | Hefei | China | 230001 | |
| 69 | Shandong Cancer Hospital | Jinan | China | 250117 | |
| 70 | Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing City | China | 210029 | |
| 71 | Fudan University Shanghai Cancer Center; Medical Oncology | Shanghai City | China | 201315 | |
| 72 | Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province) | Shijiazhuang | China | 050035 | |
| 73 | Tianjin Cancer Hospital | Tianjin | China | 300060 | |
| 74 | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan City | China | 430023 | |
| 75 | Hubei Cancer Hospital | Wuhan | China | 430079 | |
| 76 | First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | China | 710061 | |
| 77 | Henan Cancer Hospital | Zhengzhou | China | 450008 | |
| 78 | Herlev Hospital; Afdeling for Kræftbehandling | Herlev | Denmark | 2730 | |
| 79 | Vejle Sygehus; Onkologisk Afdeling | Vejle | Denmark | 7100 | |
| 80 | Polyclinique Bordeaux Nord Aquitaine | Bordeaux | France | 33300 | |
| 81 | Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne | Clermont-ferrand | France | 63003 | |
| 82 | Centre Georges Francois Leclerc; Oncologie 3 | Dijon | France | 21079 | |
| 83 | Centre Oscar Lambret; Senologie | Lille | France | 59020 | |
| 84 | Hopital Dupuytren; Oncologie Medicale | Limoges | France | 87042 | |
| 85 | Hopital Prive Jean Mermoz; Cancerologie | Lyon | France | 69373 | |
| 86 | Institut régional du Cancer Montpellier | Montpellier | France | 34298 | |
| 87 | Institut Universitaire du Cancer de Toulouse-Oncopole | Toulouse | France | 31059 | |
| 88 | Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie | Berlin | Germany | 10967 | |
| 89 | Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters | Berlin | Germany | 13581 | |
| 90 | Gynäkologisches Zentrum Bonn | Bonn | Germany | 53111 | |
| 91 | Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | Germany | 01307 | |
| 92 | Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum | Essen | Germany | 45136 | |
| 93 | Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 94 | St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe | Koeln | Germany | 50935 | |
| 95 | Helios Klinikum Krefeld; Zentrum für ambulante gynäkologische Onkologie (ZAGO) | Krefeld | Germany | 47805 | |
| 96 | Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde | Leipzig | Germany | 04103 | |
| 97 | Universitätsklinikum Mannheim; Frauenklinik | Mannheim | Germany | 68167 | |
| 98 | Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt | München | Germany | 80337 | |
| 99 | St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik | Paderborn | Germany | 33098 | |
| 100 | Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie | Recklinghausen | Germany | 45659 | |
| 101 | Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie | Trier | Germany | 54290 | |
| 102 | Universitätsfrauenklinik Ulm; Abteilung Gynäkologie | Ulm | Germany | 89075 | |
| 103 | Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine | Athens | Greece | 115 22 | |
| 104 | Univ General Hosp Heraklion; Medical Oncology | Heraklion | Greece | 711 10 | |
| 105 | Metropolitan Hospital; Dept. of Oncology | Pireaus | Greece | 185 47 | |
| 106 | Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | Greece | 546 45 | |
| 107 | Queen Mary Hospital; Dept of Medicine | Hong Kong | Hong Kong | ||
| 108 | Prince of Wales Hospital; Department of Clinical Onocology | Shatin | Hong Kong | ||
| 109 | Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly | Budapest | Hungary | 1122 | |
| 110 | Uzsoki Utcai Korhaz; Onkoradiológiai Osztály | Budapest | Hungary | 1145 | |
| 111 | Debreceni Egyetem Klinikai Kozpont ; Department of Oncology | Debrecen | Hungary | 4032 | |
| 112 | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont | Szolnok | Hungary | 5004 | |
| 113 | Azienda Ospedaliera Universitaria Federico II | Napoli | Campania | Italy | 80131 |
| 114 | A.O. Universitaria Di Parma | Parma | Emilia-Romagna | Italy | 43100 |
| 115 | Irccs Centro Di Riferimento Oncologico (CRO) | Aviano | Friuli-Venezia Giulia | Italy | 33081 |
| 116 | Azienda Ospedaliera Univ di Udine; Oncologia Medica | Udine | Friuli-Venezia Giulia | Italy | 33100 |
| 117 | Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica | Roma | Lazio | Italy | 00168 |
| 118 | Asst Papa Giovanni XXIII; Oncologia Medica | Bergamo | Lombardia | Italy | 24127 |
| 119 | Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina | Brescia | Lombardia | Italy | 25123 |
| 120 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | Lombardia | Italy | 20133 |
| 121 | Ospedale Santa Maria Annunziata; Oncologia | Bagno a Ripoli | Toscana | Italy | 50012 |
| 122 | Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2 | Pisa | Toscana | Italy | 56126 |
| 123 | IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II | Padova | Veneto | Italy | 35128 |
| 124 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
| 125 | Chungbuk National University Hospital | Cheongju-si | Korea, Republic of | 28644 | |
| 126 | Kyungpook National University Medical Center | Daegu | Korea, Republic of | 41404 | |
| 127 | Soon Chun Hyang University Cheonan Hospital | Dongnam-gu, Cheonan-si | Korea, Republic of | 31151 | |
| 128 | National Cancer Center | Goyang-si | Korea, Republic of | 10408 | |
| 129 | Inha University Hospital | Incheon | Korea, Republic of | 22332 | |
| 130 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13605 | |
| 131 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
| 132 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 133 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 134 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 135 | Gangnam Severance Hospital | Seoul | Korea, Republic of | 06273 | |
| 136 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 137 | Seoul St Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 138 | Borame Medical Center | Seoul | Korea, Republic of | 07061 | |
| 139 | Ewha Womans University Mokdong Hospital | Seoul | Korea, Republic of | 07985 | |
| 140 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 | |
| 141 | Auckland City Hospital; Clinical Oncology | Auckland | New Zealand | 1023 | |
| 142 | Christchurch Hospital NZ | Christchurch | New Zealand | 8011 | |
| 143 | Waikato Hospital; Dept of Medical Oncology | Hamilton | New Zealand | 3240 | |
| 144 | Palmerston North Hospital; Regional Cancer Treatment Service | Palmerston North | New Zealand | 4442 | |
| 145 | Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii | Bydgoszcz | Poland | 85-796 | |
| 146 | Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdańsk | Poland | 80-214 | |
| 147 | Narodowy Instytut Onkologii Odział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi | Gliwice | Poland | 44-102 | |
| 148 | Przychodnia Lekarska KOMED, Roman Karaszewski | Konin | Poland | 62-500 | |
| 149 | Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Poland | 90-242 | |
| 150 | Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym | Opole | Poland | 45-061 | |
| 151 | Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | Poland | 05-400 | |
| 152 | Lecznice Citomed Sp. z o.o. | Torun | Poland | 87-100 | |
| 153 | Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr | Warszawa | Poland | 02-781 | |
| 154 | Wojskowy Instytut Medyczny; Klinika Onkologii | Warszawa | Poland | 04-141 | |
| 155 | Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii | Wrocław | Poland | 53-413 | |
| 156 | Centro Clinico Champalimaud; Oncologia Medica | Lisboa | Portugal | 1400-038 | |
| 157 | Hospital de Santa Maria; Servico de Oncologia Medica | Lisboa | Portugal | 1649-035 | |
| 158 | Centro Hospitalar do Porto - Hospital de Santo António; Oncologia | Porto | Portugal | 4099-001 | |
| 159 | IPO do Porto; Servico de Oncologia Medica | Porto | Portugal | 4200-072 | |
| 160 | Moscow Clinical Scientific Center | Moscow | Moskovskaja Oblast | Russian Federation | 111123 |
| 161 | Blokhin Cancer Research Center; Out-Patients Dept | Moscow | Moskovskaja Oblast | Russian Federation | 115552 |
| 162 | MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy | Moscow | Moskovskaja Oblast | Russian Federation | 143422 |
| 163 | LLC Medscan | Moskva | Moskovskaja Oblast | Russian Federation | 119421 |
| 164 | Clinical Hospital Lapino (LLC Haven) | Yudino | Moskovskaja Oblast | Russian Federation | 143081 |
| 165 | Medical Clinic "AB Medical group" | Sankt-peterburg | Sankt Petersburg | Russian Federation | 196006 |
| 166 | Regional Oncology Dispensary; Dept of Chemotherapy | Novgorod Veliky | Russian Federation | 173016 | |
| 167 | Volgograd Regional Clinical Oncology Dispensary | Volgograd | Russian Federation | 400138 | |
| 168 | Regional Clinical Oncology Hospital | Yaroslavl | Russian Federation | 150040 | |
| 169 | National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore | Singapore | 119228 | |
| 170 | National Cancer Centre; Medical Oncology | Singapore | Singapore | 169610 | |
| 171 | Hospital General Universitario de Elche; Servicio de Oncologia | Elche | Alicante | Spain | 03203 |
| 172 | Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona | Spain | 08916 |
| 173 | Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Majadahonda | Madrid | Spain | 28222 |
| 174 | Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarra | Spain | 31008 |
| 175 | Hospital Universitario de Canarias;servicio de Oncologia | La Laguna | Tenerife | Spain | 38320 |
| 176 | Hospital del Mar; Servicio de Oncologia | Barcelona | Spain | 08003 | |
| 177 | Vall d´Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | Spain | 08035 | |
| 178 | Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department | Barcelona | Spain | 08036 | |
| 179 | Insituto Catalán de Oncologia (ICO) | Barcelona | Spain | 08907 | |
| 180 | Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaen | Spain | 23007 | |
| 181 | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | Spain | 28007 | |
| 182 | Clinica Universidad de Navarra-Madrid | Madrid | Spain | 28027 | |
| 183 | Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | Spain | 28040 | |
| 184 | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | Spain | 28041 | |
| 185 | Hospital Universitario Virgen Macarena; Servicio de Oncologia | Sevilla | Spain | 41009 | |
| 186 | Instituto Valenciano Oncologia; Oncologia Medica | Valencia | Spain | 46009 | |
| 187 | Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | Spain | 46010 | |
| 188 | Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery | Kaohsiung | Taiwan | 807 | |
| 189 | Chi-Mei Medical Centre; Hematology & Oncology | Tainan | Taiwan | 710 | |
| 190 | Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology | Taipei City | Taiwan | 11259 | |
| 191 | VETERANS GENERAL HOSPITAL; Department of General Surgery | Taipei | Taiwan | 00112 | |
| 192 | National Taiwan Uni Hospital; General Surgery | Taipei | Taiwan | 100 | |
| 193 | Tri-Service General Hospital, Division of General Surgery | Taipei | Taiwan | 114 | |
| 194 | Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | Thailand | 10400 | |
| 195 | Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial | Chiang Mai | Thailand | 50200 | |
| 196 | Chulabhorn Hospital; Medical Oncology | Lak Si | Thailand | 10210 | |
| 197 | Songklanagarind Hospital; Department of Oncology | Songkhla | Thailand | 90110 | |
| 198 | Adana Baskent University Hospital; Medical Oncology | Adana | Turkey | 01120 | |
| 199 | Gulhane Training and Research Hospital | Ankara | Turkey | 06010 | |
| 200 | Memorial Ankara Hastanesi | Ankara | Turkey | 06520 | |
| 201 | Ege University Medical Faculty; Medical Oncology Department | Bornova, İ̇zmi̇r | Turkey | 35100 | |
| 202 | Istanbul University Cerrahpasa Faculty of Medicine | Istanbul | Turkey | 34098 | |
| 203 | Prof. Dr. Cemil Tascioglu City Hospital; Med Onc | Istanbul | Turkey | 34384 | |
| 204 | Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department | Istanbul | Turkey | 34865 | |
| 205 | SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department | Kharkiv | Kharkiv Governorate | Ukraine | 61018 |
| 206 | Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2 | Ivano-Frankivsk | KIEV Governorate | Ukraine | 76018 |
| 207 | Uzhhorod Central City Clinical Hospital | Uzhhorod | KIEV Governorate | Ukraine | 88000 |
| 208 | City Clinical Hospital #4 | Dnipropetrovsk | Ukraine | 49102 | |
| 209 | ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department | Kryvyi Rih | Ukraine | 50048 | |
| 210 | Kyiv City Clinical Oncological Center | Kyiv | Ukraine | 03115 | |
| 211 | RCI Sumy Regional Clinical Oncological Dispensary | Sumy | Ukraine | 40005 | |
| 212 | Bristol Royal Infirmary | Bristol | United Kingdom | BS2 8HW | |
| 213 | Princess Alexandra Hospital; Oncology Department | Harlow | United Kingdom | CM20 1QX | |
| 214 | Raigmore Hospital | Inverness | United Kingdom | IV2 3UV | |
| 215 | Rutherford Cancer Centre - Liverpool | Liverpool | United Kingdom | L7 3EW | |
| 216 | Barts Health NHS Trust; Cancer Research Delivery Group | London | United Kingdom | EC1A 7BE | |
| 217 | St Georges University Hospitals NHS Foundation Trust | London | United Kingdom | SW17 0RE | |
| 218 | Royal Marsden Hospital - Fulham; Oncology Department | London | United Kingdom | SW3 6JJ | |
| 219 | Maidstone Hospital; Kent Oncology Centre | Maidstone | United Kingdom | ME16 9QQ | |
| 220 | Christie Foundation Trust | Manchester | United Kingdom | M20 4BX | |
| 221 | Rutherford Cancer Centre - South Wales | Newport | United Kingdom | NP10 8FZ | |
| 222 | Mount Vernon Hospital; Mount Vernon Cancer Centre | Northwood | United Kingdom | HA6 2RN | |
| 223 | Nottingham City Hospital | Nottingham | United Kingdom | NG5 1PB | |
| 224 | Churchill Hospital; Department of Oncology | Oxford | United Kingdom | OX3 7LE | |
| 225 | Peterborough City Hospital, Edith Cavell Campus; Oncology Department | Peterborough | United Kingdom | PE3 9GZ | |
| 226 | Derriford Hospital | Plymouth | United Kingdom | PL6 8DH | |
| 227 | Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital | Portsmouth | United Kingdom | PO6 3LY | |
| 228 | Rutherford Cancer Centre - Thames Valley | Reading | United Kingdom | RG2 9LH | |
| 229 | Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04191499
Other Study ID Numbers:
- WO41554
- 2019-002455-42
First Posted:
Dec 9, 2019
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: