Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,068

Participants

Timeline

Start Date

October 14, 2020

Primary Completion Date

June 28, 2022

Study Completion Date

May 26, 2023

Conditions
Breast Cancer
Interventions
DRUG

Amcenestrant-matching placebo

Pharmaceutical form: Tablets Route of Administration: Oral

DRUG

SAR439859

Pharmaceutical form: Tablets Route of Administration: Oral

DRUG

Palbociclib

Pharmaceutical form: Capsules/Tablets Route of Administration: Oral

DRUG

Letrozole

Pharmaceutical form: Capsules Route of Administration: Orally

DRUG

Goserelin

Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

DRUG

Letrozole-matching placebo

Pharmaceutical form: Capsules Route of Administration: Orally

Trial Locations (249)

100

Investigational Site Number :1580001, Taipei

807

Investigational Site Number :1580007, Kaohsiung City

1115

Investigational Site Number :3480008, Budapest

1709

Investigational Site Number :7100006, Johannesburg

1797

Investigational Site Number :1000001, Sofia

2000

Investigational Site Number :0320002, Rosario

2031

Investigational Site Number :0360005, Randwick

2076

Investigational Site Number :0360003, Wahroonga

2109

Investigational Site Number :0360004, Macquarie Park

3000

Investigational Site Number :0560001, Leuven

3121

Investigational Site Number :0360002, Richmond

3526

Investigational Site Number :3480010, Miskolc

4400

Investigational Site Number :0320007, Salta

Investigational Site Number :3480001, Nyíregyháza

4600

Investigational Site Number :2680006, Kutaisi

5000

Investigational Site Number :0320010, Córdoba

Investigational Site Number :0560002, Namur

5300

Investigational Site Number :0320003, La Rioja

5700

Investigational Site Number :3480011, Gyula

6000

Investigational Site Number :2680005, Batumi

Investigational Site Number :3480009, Kecskemét

6009

Investigational Site Number :0360001, Nedlands

6591

Investigational Site Number :4100009, Seochogu

7002

Investigational Site Number :1000008, Rousse

7400

Investigational Site Number :3480003, Kaposvár

7570

Investigational Site Number :7100004, Cape Town

8000

Investigational Site Number :1000004, Burgas

8036

Investigational Site Number :0400001, Graz

9023

Investigational Site Number :3480005, Győr

10016

Investigational Site Number :8400010, New York

10408

Investigational Site Number :4100006, Goyang-si

10449

Investigational Site Number :1580003, Taipei

12808

Investigational Site Number :2030002, Prague

13496

Investigational Site Number :4100008, Seongnam-si, Gyeonggi-do

15232

Investigational Site Number :8400001, Pittsburgh

15706

Investigational Site Number :7240003, Santiago de Compostela

20052

Investigational Site Number :3800007, Monza

20089

Investigational Site Number :3800003, Rozzano

20132

Investigational Site Number :3800004, Milan

20141

Investigational Site Number :3800002, Milan

21029

Investigational Site Number :8040007, Vinnytsia

21100

Investigational Site Number :7920013, Diyarbakır

22030

Investigational Site Number :7920003, Edirne

22601

Investigational Site Number :8400069, Winchester

23758

Investigational Site Number :2760007, Oldenburg in Holstein

24060

Investigational Site Number :8400085, Blacksburg

27157

Investigational Site Number :8400009, Winston-Salem

28007

Investigational Site Number :7240006, Madrid / Madrid

28041

Investigational Site Number :7240001, Madrid

28046

Investigational Site Number :7240004, Madrid

28050

Investigational Site Number :7240002, Madrid / Madrid

29010

Investigational Site Number :7240007, Málaga

30342

Investigational Site Number :8400016, Atlanta

30607

Investigational Site Number :8400055, Athens

31059

Investigational Site Number :2500005, Toulouse

31405

Investigational Site Number :8400034, Savannah

31792

Investigational Site Number :8400035, Thomasville

32804

Investigational Site Number :8400053, Orlando

32901

Investigational Site Number :8400081, Palm Bay

33520

Investigational Site Number :2460002, Tampere

33805

Investigational Site Number :8400059, Lakeland

34214

Investigational Site Number :7920001, Istanbul

34457

Investigational Site Number :7920011, Istanbul

34722

Investigational Site Number :7920004, Istanbul

35100

Investigational Site Number :7920005, Bornova

36526

Investigational Site Number :8400075, Daphne

40138

Investigational Site Number :3800010, Bologna

41380

Investigational Site Number :7920010, Kocaeli

44280

Investigational Site Number :7920002, Malatya

44805

Investigational Site Number :2500002, Saint-Herblain

46010

Investigational Site Number :7240005, Valencia

46015

Investigational Site Number :7240009, Valencia

46236

Investigational Site Number :2760006, Bottrop

46804

Investigational Site Number :8400008, Fort Wayne

47014

Investigational Site Number :3800008, Meldola (FC)

48109

Investigational Site Number :8400002, Ann Arbor

48149

Investigational Site Number :2760003, Münster

50048

Investigational Site Number :8040001, Kryvyi Rih

52242

Investigational Site Number :8400006, Iowa City

59100

Investigational Site Number :3800005, Prato

60612

Investigational Site Number :8400039, Chicago

61103

Investigational Site Number :8040004, Kharkiv

61166

Investigational Site Number :8040010, Kharkiv

63141

Investigational Site Number :8400004, St Louis

64111

Investigational Site Number :8400005, Kansas City

65025

Investigational Site Number :8040002, Odesa

65653

Investigational Site Number :2030001, Brno

67033

Investigational Site Number :2500010, Strasbourg

75010

Investigational Site Number :2500003, Paris

75093

Investigational Site Number :8400084, Plano

75231

Investigational Site Number :8400072, Dallas

75246

Investigational Site Number :8400070, Dallas

75248

Investigational Site Number :2500001, Paris

76021

Investigational Site Number :8400080, Denton

76712

Investigational Site Number :8400078, Waco

77024

Investigational Site Number :8400061, Houston

Investigational Site Number :8400068, Houston

77380

Investigational Site Number :8400086, The Woodlands

77598

Investigational Site Number :8400082, Webster

78745

Investigational Site Number :8400073, Austin

80131

Investigational Site Number :3800006, Napoli

80262

Investigational Site Number :8400025, Denver

85308

Investigational Site Number :8400083, Glendale

85712

Investigational Site Number :8400066, Tucson

86021

Investigational Site Number :2500006, Poitiers

89075

Investigational Site Number :2760001, Ulm

89102

Investigational Site Number :8400058, Las Vegas

90404

Investigational Site Number :8400029, Santa Monica

90720

Investigational Site Number :8400056, Los Alamitos

92210

Investigational Site Number :2500007, Saint-Cloud

92835

Investigational Site Number :8400038, Fullerton

94800

Investigational Site Number :2500004, Villejuif

97223

Investigational Site Number :8400067, Tigard

100142

Investigational Site Number :1560008, Beijing

100730

Investigational Site Number :1560035, Beijing

115478

Investigational Site Number :6430008, Moscow

116011

Investigational Site Number :1560031, Dalian

116027

Investigational Site Number :1560021, Dalian

117186

Investigational Site Number :6430003, Moscow

117997

Investigational Site Number :6430005, Moscow

119228

Investigational Site Number :7020002, Singapore

129090

Investigational Site Number :6430006, Moscow

130021

Investigational Site Number :1560003, Changchun

130041

Investigational Site Number :1560036, Changchun

143423

Investigational Site Number :6430004, Krasnogorskiy District

143442

Investigational Site Number :6430009, Moscow Region

150081

Investigational Site Number :1560011, Harbin

163045

Investigational Site Number :6430007, Arkhangelsk

169610

Investigational Site Number :7020004, Singapore

197758

Investigational Site Number :6430001, Saint Petersburg

199034

Investigational Site Number :6430010, Saint Petersburg

200032

Investigational Site Number :1560001, Shanghai

221009

Investigational Site Number :1560027, Xuzhou

233004

Investigational Site Number :1560041, Hefei

250013

Investigational Site Number :1560018, Jinan

250117

Investigational Site Number :1560046, Jinan

264000

Investigational Site Number :1560049, Yantai

276000

Investigational Site Number :1560017, Linyi

300060

Investigational Site Number :1560028, Tianjin

310003

Investigational Site Number :1560006, Hangzhou

310009

Investigational Site Number :1560007, Hangzhou

310016

Investigational Site Number :1560002, Hangzhou

310022

Investigational Site Number :1560005, Hangzhou

329563

Investigational Site Number :7020001, Singapore

354200

Investigational Site Number :1560043, Fuzhou

400030

Investigational Site Number :1560019, Chongqing

430060

Investigational Site Number :1560033, Wuhan

430079

Investigational Site Number :1560024, Wuhan

450008

Investigational Site Number :1560022, Zhengzhou

471003

Investigational Site Number :1560055, Luoyang

510080

Investigational Site Number :1560025, Guangzhou

512025

Investigational Site Number :1560037, Shaoguan

610041

Investigational Site Number :1560013, Chengdu

618000

Investigational Site Number :1560054, Deyang

641003

Investigational Site Number :1560048, Neijiang

710004

Investigational Site Number :1560045, Xi'an

710061

Investigational Site Number :1560044, Xi'an

1720430

Investigational Site Number :1520005, La Serena

2520598

Investigational Site Number :1520001, Viña del Mar

4810561

Investigational Site Number :1520004, Temuco

7500921

Investigational Site Number :1520007, Santiago

7650568

Investigational Site Number :1520006, Santiago

8241470

Investigational Site Number :1520011, Santaigo

8420383

Investigational Site Number :1520002, Santiago

66205-2003

Investigational Site Number :8400013, Westwood

04074-9308

Investigational Site Number :8400028, Scarborough

02114

Investigational Site Number :8400017, Boston

01923

Investigational Site Number :8400076, Danvers

02463

Investigational Site Number :8400077, Newton

08901-1914

Investigational Site Number :8400015, New Brunswick

00000

Investigational Site Number :8400024, Paramus

11794-8121

Investigational Site Number :8400023, Stony Brook

C1012AAR

Investigational Site Number :0320001, CABA

C1019ABS

Investigational Site Number :0320005, CABA

C1417DTB

Investigational Site Number :0320008, Capital Federal

B2700CPM

Investigational Site Number :0320006, Pergamino

C1125ABD

Investigational Site Number :0320004, Buenos Aires

B7600FYK

Investigational Site Number :0320009, Mar del Plata

BE-1200

Investigational Site Number :0560003, Brussels

B-6000

Investigational Site Number :0560004, Charleroi

90035 003

Investigational Site Number :0760005, Porto Alegre

91350-250

Investigational Site Number :0760006, Porto Alegre

01509-900

Investigational Site Number :0760007, São Paulo

04014-002

Investigational Site Number :0760003, São Paulo

20230-130

Investigational Site Number :0760004, Rio de Janeiro

04321-120

Investigational Site Number :0760008, São Paulo

Unknown

Investigational Site Number :1000005, Dobrich

Investigational Site Number :1520009, Talca

Investigational Site Number :1520003, Santiago

Investigational Site Number :1560051, Jining

Investigational Site Number :1580002, Tainan City

K7L 2V7

Investigational Site Number :1240004, Kingston

M4N 3M5

Investigational Site Number :1240002, Toronto

J4V 2H1

Investigational Site Number :1240007, Greenfield Park

H3T 1S6

Investigational Site Number :1240014, Montreal

H4A 3J1

Investigational Site Number :1240005, Montreal

071000

Investigational Site Number :1560038, Baoding

00029

Investigational Site Number :2460001, Helsinki

FIN-20520

Investigational Site Number :2460003, Turku

06189

Investigational Site Number :2500009, Nice

0112

Investigational Site Number :2680001, Tbilisi

0144

Investigational Site Number :2680002, Tbilisi

0159

Investigational Site Number :2680004, Tbilisi

Investigational Site Number :2680007, Tbilisi

0168

Investigational Site Number :2680003, Tbilisi

460-0001

Investigational Site Number :3920016, Nagoya

464-8681

Investigational Site Number :3920007, Nagoya

277-8577

Investigational Site Number :3920002, Kashiwa-shi

791-0280

Investigational Site Number :3920009, Matsuyama

830-0013

Investigational Site Number :3920019, Kurume-shi

370-0829

Investigational Site Number :3920017, Takasaki-shi

730-8518

Investigational Site Number :3920010, Hiroshima

003-0804

Investigational Site Number :3920001, Sapporo

892-0833

Investigational Site Number :3920012, Kagoshima

222-0036

Investigational Site Number :3920014, Yokohama

241-8515

Investigational Site Number :3920006, Yokohama

980-0803

Investigational Site Number :3920020, Sendai

880-8510

Investigational Site Number :3920022, Miyazaki

540-0006

Investigational Site Number :3920008, Osaka

553-0003

Investigational Site Number :3920018, Osaka

350-1241

Investigational Site Number :3920013, Hidaka-shi

420-8527

Investigational Site Number :3920021, Shizuoka

135-8550

Investigational Site Number :3920003, Koto-ku

152-8902

Investigational Site Number :3920015, Meguro-ku

142-8666

Investigational Site Number :3920005, Shinagawa-ku

6815 AD

Investigational Site Number :5280006, Arnhem

2625 AD

Investigational Site Number :5280005, Delft

6229 HX

Investigational Site Number :5280001, Maastricht

61-866

Investigational Site Number :6160007, Poznan

97-200

Investigational Site Number :6160002, Tomaszów Mazowiecki

2801-951

Investigational Site Number :6200005, Almada

1649-035

Investigational Site Number :6200001, Lisbon

4200-319

Investigational Site Number :6200002, Porto

463-707

Investigational Site Number :4100005, Seongnam-si

02841

Investigational Site Number :4100007, Seoul

03722

Investigational Site Number :4100004, Seoul

110-744

Investigational Site Number :4100003, Seoul

135-710

Investigational Site Number :4100002, Seoul

138-878

Investigational Site Number :4100001, Seoul

08017

Investigational Site Number :7240011, Barcelona

08208

Investigational Site Number :7240008, Barcelona / Sabadell

01120

Investigational Site Number :7920006, Adana

06100

Investigational Site Number :7920008, Ankara

06200

Investigational Site Number :7920009, Ankara

07070

Investigational Site Number :7920007, Antalya

0000

Investigational Site Number :7920012, Izmir

G12 0YN

Investigational Site Number :8260001, Glasgow

EH4 2XU

Investigational Site Number :8260002, Edinburgh

BB2 3HH

Investigational Site Number :8260005, Blackburn

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT04478266 - Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer | Biotech Hunter | Biotech Hunter