Spots Global Cancer Trial Database for Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
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Trial Identification
Brief Title: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Official Title: A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Study ID: NCT04478266
Conditions
Study Description
Brief Summary: Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: * To compare the overall survival in both treatment arms. * To evaluate the objective response rate in both treatment arms. * To evaluate the duration of response in both treatment arms. * To evaluate the clinical benefit rate in both treatment arms. * To evaluate progression-free survival on next line of therapy. * To evaluate the pharmacokinetics of amcenestrant, and palbociclib. * To evaluate health-related quality of life in both treatment arms. * To evaluate the time to first chemotherapy in both treatment arms. * To evaluate safety in both treatment arms.
Detailed Description: Study duration per participant was approximately 59 months, which includes a 33- month treatment period.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number :8400075, Daphne, Alabama, United States
Investigational Site Number :8400083, Glendale, Arizona, United States
Investigational Site Number :8400066, Tucson, Arizona, United States
Investigational Site Number :8400038, Fullerton, California, United States
Investigational Site Number :8400056, Los Alamitos, California, United States
Investigational Site Number :8400029, Santa Monica, California, United States
Investigational Site Number :8400025, Denver, Colorado, United States
Investigational Site Number :8400059, Lakeland, Florida, United States
Investigational Site Number :8400053, Orlando, Florida, United States
Investigational Site Number :8400081, Palm Bay, Florida, United States
Investigational Site Number :8400055, Athens, Georgia, United States
Investigational Site Number :8400016, Atlanta, Georgia, United States
Investigational Site Number :8400034, Savannah, Georgia, United States
Investigational Site Number :8400035, Thomasville, Georgia, United States
Investigational Site Number :8400039, Chicago, Illinois, United States
Investigational Site Number :8400008, Fort Wayne, Indiana, United States
Investigational Site Number :8400006, Iowa City, Iowa, United States
Investigational Site Number :8400013, Westwood, Kansas, United States
Investigational Site Number :8400028, Scarborough, Maine, United States
Investigational Site Number :8400017, Boston, Massachusetts, United States
Investigational Site Number :8400076, Danvers, Massachusetts, United States
Investigational Site Number :8400077, Newton, Massachusetts, United States
Investigational Site Number :8400002, Ann Arbor, Michigan, United States
Investigational Site Number :8400005, Kansas City, Missouri, United States
Investigational Site Number :8400004, Saint Louis, Missouri, United States
Investigational Site Number :8400058, Las Vegas, Nevada, United States
Investigational Site Number :8400015, New Brunswick, New Jersey, United States
Investigational Site Number :8400024, Paramus, New Jersey, United States
Investigational Site Number :8400010, New York, New York, United States
Investigational Site Number :8400023, Stony Brook, New York, United States
Investigational Site Number :8400009, Winston-Salem, North Carolina, United States
Investigational Site Number :8400067, Tigard, Oregon, United States
Investigational Site Number :8400001, Pittsburgh, Pennsylvania, United States
Investigational Site Number :8400073, Austin, Texas, United States
Investigational Site Number :8400072, Dallas, Texas, United States
Investigational Site Number :8400070, Dallas, Texas, United States
Investigational Site Number :8400080, Denton, Texas, United States
Investigational Site Number :8400061, Houston, Texas, United States
Investigational Site Number :8400068, Houston, Texas, United States
Investigational Site Number :8400084, Plano, Texas, United States
Investigational Site Number :8400086, The Woodlands, Texas, United States
Investigational Site Number :8400078, Waco, Texas, United States
Investigational Site Number :8400082, Webster, Texas, United States
Investigational Site Number :8400085, Blacksburg, Virginia, United States
Investigational Site Number :8400069, Winchester, Virginia, United States
Investigational Site Number :0320001, Caba, Buenos Aires, Argentina
Investigational Site Number :0320005, Caba, Buenos Aires, Argentina
Investigational Site Number :0320008, Capital Federal, Buenos Aires, Argentina
Investigational Site Number :0320006, Pergamino, Buenos Aires, Argentina
Investigational Site Number :0320010, Cordoba, Córdoba, Argentina
Investigational Site Number :0320002, Rosario, Santa Fe, Argentina
Investigational Site Number :0320004, Buenos Aires, , Argentina
Investigational Site Number :0320003, La Rioja, , Argentina
Investigational Site Number :0320009, Mar del Plata, , Argentina
Investigational Site Number :0320007, Salta, , Argentina
Investigational Site Number :0360004, Macquarie Park, New South Wales, Australia
Investigational Site Number :0360005, Randwick, New South Wales, Australia
Investigational Site Number :0360003, Wahroonga, New South Wales, Australia
Investigational Site Number :0360002, Richmond, Victoria, Australia
Investigational Site Number :0360001, Nedlands, Western Australia, Australia
Investigational Site Number :0400001, Graz, , Austria
Investigational Site Number :0560003, Bruxelles, , Belgium
Investigational Site Number :0560004, Charleroi, , Belgium
Investigational Site Number :0560001, Leuven, , Belgium
Investigational Site Number :0560002, Namur, , Belgium
Investigational Site Number :0760005, Porto Alegre, Rio Grande Do Sul, Brazil
Investigational Site Number :0760006, Porto Alegre, Rio Grande Do Sul, Brazil
Investigational Site Number :0760007, Sao Paulo, São Paulo, Brazil
Investigational Site Number :0760003, Sao Paulo, São Paulo, Brazil
Investigational Site Number :0760004, Rio De Janeiro, , Brazil
Investigational Site Number :0760008, São Paulo, , Brazil
Investigational Site Number :1000004, Burgas, , Bulgaria
Investigational Site Number :1000005, Dobrich, , Bulgaria
Investigational Site Number :1000008, Russe, , Bulgaria
Investigational Site Number :1000001, Sofia, , Bulgaria
Investigational Site Number :1240004, Kingston, Ontario, Canada
Investigational Site Number :1240002, Toronto, Ontario, Canada
Investigational Site Number :1240007, Greenfield Park, Quebec, Canada
Investigational Site Number :1240014, Montreal, Quebec, Canada
Investigational Site Number :1240005, Montreal, Quebec, Canada
Investigational Site Number :1520005, La Serena, Coquimbo, Chile
Investigational Site Number :1520004, Temuco, La Araucanía, Chile
Investigational Site Number :1520009, Talca, Maule, Chile
Investigational Site Number :1520011, Santaigo, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520006, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520002, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520001, Viña del Mar, Valparaíso, Chile
Investigational Site Number :1520003, Santiago de Chile, , Chile
Investigational Site Number :1520007, Santiago, , Chile
Investigational Site Number :1560038, Baoding, , China
Investigational Site Number :1560008, Beijing, , China
Investigational Site Number :1560035, Beijing, , China
Investigational Site Number :1560003, Changchun, , China
Investigational Site Number :1560036, Changchun, , China
Investigational Site Number :1560013, Chengdu, , China
Investigational Site Number :1560019, Chongqing, , China
Investigational Site Number :1560031, Dalian, , China
Investigational Site Number :1560021, Dalian, , China
Investigational Site Number :1560054, Deyang, , China
Investigational Site Number :1560043, Fuzhou, , China
Investigational Site Number :1560025, Guangzhou, , China
Investigational Site Number :1560006, Hangzhou, , China
Investigational Site Number :1560007, Hangzhou, , China
Investigational Site Number :1560002, Hangzhou, , China
Investigational Site Number :1560005, Hangzhou, , China
Investigational Site Number :1560011, Harbin, , China
Investigational Site Number :1560041, Hefei, , China
Investigational Site Number :1560018, Jinan, , China
Investigational Site Number :1560046, Jinan, , China
Investigational Site Number :1560051, Jining, , China
Investigational Site Number :1560017, Linyi, , China
Investigational Site Number :1560055, Luoyang, , China
Investigational Site Number :1560048, Neijiang, , China
Investigational Site Number :1560001, Shanghai, , China
Investigational Site Number :1560037, Shaoguan, , China
Investigational Site Number :1560028, Tianjin, , China
Investigational Site Number :1560033, Wuhan, , China
Investigational Site Number :1560024, Wuhan, , China
Investigational Site Number :1560045, Xi'an, , China
Investigational Site Number :1560044, Xi'An, , China
Investigational Site Number :1560027, Xuzhou, , China
Investigational Site Number :1560049, Yantai, , China
Investigational Site Number :1560022, Zhengzhou, , China
Investigational Site Number :2030001, Brno, , Czechia
Investigational Site Number :2030002, Praha 2, , Czechia
Investigational Site Number :2460001, Helsinki, , Finland
Investigational Site Number :2460002, Tampere, , Finland
Investigational Site Number :2460003, Turku, , Finland
Investigational Site Number :2500009, Nice, , France
Investigational Site Number :2500003, Paris, , France
Investigational Site Number :2500001, Paris, , France
Investigational Site Number :2500006, Poitiers, , France
Investigational Site Number :2500007, Saint Cloud, , France
Investigational Site Number :2500002, Saint-Herblain, , France
Investigational Site Number :2500010, Strasbourg, , France
Investigational Site Number :2500005, TOULOUSE Cedex 9, , France
Investigational Site Number :2500004, Villejuif, , France
Investigational Site Number :2680005, Batumi, , Georgia
Investigational Site Number :2680006, Kutaisi, , Georgia
Investigational Site Number :2680001, Tbilisi, , Georgia
Investigational Site Number :2680002, Tbilisi, , Georgia
Investigational Site Number :2680004, Tbilisi, , Georgia
Investigational Site Number :2680007, Tbilisi, , Georgia
Investigational Site Number :2680003, Tbilisi, , Georgia
Investigational Site Number :2760006, Bottrop, , Germany
Investigational Site Number :2760003, Münster, , Germany
Investigational Site Number :2760007, Oldenburg in Holstein, , Germany
Investigational Site Number :2760001, Ulm, , Germany
Investigational Site Number :3480008, Budapest, , Hungary
Investigational Site Number :3480011, Gyula, , Hungary
Investigational Site Number :3480005, Győr, , Hungary
Investigational Site Number :3480003, Kaposvár, , Hungary
Investigational Site Number :3480009, Kecskemét, , Hungary
Investigational Site Number :3480010, Miskolc, , Hungary
Investigational Site Number :3480001, Nyíregyháza, , Hungary
Investigational Site Number :3800008, Meldola (FC), Emilia-Romagna, Italy
Investigational Site Number :3800003, Rozzano, Milano, Italy
Investigational Site Number :3800007, Monza, Monza E Brianza, Italy
Investigational Site Number :3800010, Bologna, , Italy
Investigational Site Number :3800004, Milano, , Italy
Investigational Site Number :3800002, Milano, , Italy
Investigational Site Number :3800006, Napoli, , Italy
Investigational Site Number :3800005, Prato, , Italy
Investigational Site Number :3920016, Nagoya-shi, Aichi, Japan
Investigational Site Number :3920007, Nagoya-shi, Aichi, Japan
Investigational Site Number :3920002, Kashiwa-shi, Chiba, Japan
Investigational Site Number :3920009, Matsuyama-shi, Ehime, Japan
Investigational Site Number :3920019, Kurume-shi, Fukuoka, Japan
Investigational Site Number :3920017, Takasaki-shi, Gunma, Japan
Investigational Site Number :3920010, Hiroshima-shi, Hiroshima, Japan
Investigational Site Number :3920001, Sapporo-shi, Hokkaido, Japan
Investigational Site Number :3920012, Kagoshima-shi, Kagoshima, Japan
Investigational Site Number :3920014, Yokohama-shi, Kanagawa, Japan
Investigational Site Number :3920006, Yokohama-shi, Kanagawa, Japan
Investigational Site Number :3920020, Sendai-shi, Miyagi, Japan
Investigational Site Number :3920022, Miyazaki-shi, Miyazaki, Japan
Investigational Site Number :3920008, Osaka-shi, Osaka, Japan
Investigational Site Number :3920018, Osaka-shi, Osaka, Japan
Investigational Site Number :3920013, Hidaka-shi, Saitama, Japan
Investigational Site Number :3920021, Shizuoka-shi, Shizuoka, Japan
Investigational Site Number :3920003, Koto-ku, Tokyo, Japan
Investigational Site Number :3920015, Meguro-ku, Tokyo, Japan
Investigational Site Number :3920005, Shinagawa-ku, Tokyo, Japan
Investigational Site Number :4100006, Goyang-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number :4100005, Seongnam, Gyeonggi-do, Korea, Republic of
Investigational Site Number :4100007, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100004, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100003, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100009, Seochogu, , Korea, Republic of
Investigational Site Number :4100008, Seongnam-si, Gyeonggi-do, , Korea, Republic of
Investigational Site Number :5280006, Arnhem, , Netherlands
Investigational Site Number :5280005, Delft, , Netherlands
Investigational Site Number :5280001, Maastricht, , Netherlands
Investigational Site Number :6160002, Tomaszow Mazowiecki, Lódzkie, Poland
Investigational Site Number :6160007, Poznan, Wielkopolskie, Poland
Investigational Site Number :6200005, Almada, , Portugal
Investigational Site Number :6200001, Lisboa, , Portugal
Investigational Site Number :6200002, Porto, , Portugal
Investigational Site Number :6430007, Arkhangelsk, , Russian Federation
Investigational Site Number :6430004, Krasnogorskiy District, , Russian Federation
Investigational Site Number :6430009, Moscow Region, , Russian Federation
Investigational Site Number :6430008, Moscow, , Russian Federation
Investigational Site Number :6430003, Moscow, , Russian Federation
Investigational Site Number :6430005, Moscow, , Russian Federation
Investigational Site Number :6430006, Moscow, , Russian Federation
Investigational Site Number :6430001, Saint -Petersburg, , Russian Federation
Investigational Site Number :6430010, Saint Petersburg, , Russian Federation
Investigational Site Number :7020002, Singapore, , Singapore
Investigational Site Number :7020004, Singapore, , Singapore
Investigational Site Number :7020001, Singapore, , Singapore
Investigational Site Number :7100004, Cape Town, , South Africa
Investigational Site Number :7100006, Johannesburg, , South Africa
Investigational Site Number :7240011, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240008, Barcelona / Sabadell, Castilla Y León, Spain
Investigational Site Number :7240003, Santiago de Compostela, Galicia [Galicia], Spain
Investigational Site Number :7240006, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number :7240002, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number :7240004, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number :7240005, Valencia, Valenciana, Comunidad, Spain
Investigational Site Number :7240001, Madrid, , Spain
Investigational Site Number :7240007, Málaga, , Spain
Investigational Site Number :7240009, Valencia, , Spain
Investigational Site Number :1580007, Kaohsiung, , Taiwan
Investigational Site Number :1580002, Tainan, , Taiwan
Investigational Site Number :1580001, Taipei, , Taiwan
Investigational Site Number :1580003, Taipei, , Taiwan
Investigational Site Number :7920006, Adana, , Turkey
Investigational Site Number :7920008, Ankara, , Turkey
Investigational Site Number :7920009, Ankara, , Turkey
Investigational Site Number :7920007, Antalya, , Turkey
Investigational Site Number :7920005, Bornova, , Turkey
Investigational Site Number :7920013, Diyarbakır, , Turkey
Investigational Site Number :7920003, Edirne, , Turkey
Investigational Site Number :7920001, Istanbul, , Turkey
Investigational Site Number :7920011, Istanbul, , Turkey
Investigational Site Number :7920004, Istanbul, , Turkey
Investigational Site Number :7920012, İzmir, , Turkey
Investigational Site Number :7920010, Kocaeli, , Turkey
Investigational Site Number :7920002, Malatya, , Turkey
Investigational Site Number :8040004, Kharkiv, , Ukraine
Investigational Site Number :8040010, Kharkiv, , Ukraine
Investigational Site Number :8040001, Kryvyi Rih, , Ukraine
Investigational Site Number :8040002, Odesa, , Ukraine
Investigational Site Number :8040007, Vinnytsia, , Ukraine
Investigational Site Number :8260001, Glasgow, Central Bedfordshire, United Kingdom
Investigational Site Number :8260002, Edinburgh, Edinburgh, City Of, United Kingdom
Investigational Site Number :8260005, Blackburn, Lancashire, United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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