Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

October 22, 2019

Primary Completion Date

February 15, 2022

Study Completion Date

January 2, 2025

Conditions
Breast Cancer Metastatic
Interventions
DRUG

Amcenestrant

"Pharmaceutical form: Capsule~Route of administration: Oral"

DRUG

Fulvestrant

"Pharmaceutical form: Solution for injection~Route of administration: Intramuscular"

DRUG

Anastrozole

"Pharmaceutical form:Tablets or capsules~Route of administration: Oral"

DRUG

Letrozole

"Pharmaceutical form: Tablets or capsules~Route of administration: Oral"

DRUG

Exemestane

"Pharmaceutical form: Tablets or capsules~Route of administration: Oral"

DRUG

Tamoxifen

"Pharmaceutical form: Tablets or capsules~Route of administration: Oral"

Trial Locations (109)

104

Investigational Site Number : 1580005, Taipei

114

Investigational Site Number : 1580004, Taipei

704

Investigational Site Number : 1580003, Tainan City

1012

Investigational Site Number : 0320007, Capital Federal

2000

Investigational Site Number : 0320005, Rosario

3000

Investigational Site Number : 0560001, Leuven

4101

Investigational Site Number : 0360003, South Brisbane

4102

Investigational Site Number : 0360002, Woolloongabba

4400

Investigational Site Number : 0320002, Salta

5000

Investigational Site Number : 0560003, Namur

5300

Investigational Site Number : 0320004, La Rioja

6009

Investigational Site Number : 0360001, Nedlands

10018

Investigational Site Number : 1580001, Taipei

10060

Investigational Site Number : 3800001, Candiolo

13009

Investigational Site Number : 2500007, Marseille

14059

Investigational Site Number : 2030004, Prague

20141

Investigational Site Number : 3800002, Milan

22030

Investigational Site Number : 7920002, Edirne

29010

Investigational Site Number : 7240008, Málaga

34722

Investigational Site Number : 7920003, Istanbul

35205

Alabama Oncology Site Number : 8400008, Birmingham

40447

Investigational Site Number : 1580002, Taichung

41110

Investigational Site Number : 3000002, Larissa

44718

Gabrail Cancer Center Site Number : 8400006, Canton

49055

Investigational Site Number : 2500008, Angers

49100

Investigational Site Number : 3760001, Petah Tikva

50048

Investigational Site Number : 8040001, Kryvyi Rih

52621

Investigational Site Number : 3760004, Tel Litwinsky

53792

University of Wisconsin Site Number : 8400016, Madison

54645

Investigational Site Number : 3000004, Thessaloniki

59100

Investigational Site Number : 3800003, Prato

64111

Saint Luke's Hospital Site Number : 8400032, Kansas City

64239

Investigational Site Number : 3760003, Tel Aviv

64460

Investigational Site Number : 4840002, Monterrey

65025

Investigational Site Number : 8040004, Odesa

65653

Investigational Site Number : 2030002, Brno

66205

The University of Kansas Clinical Research Center Site Number : 8400027, Fairway

70808

Hematology Oncology Clinic Site Number : 8400020, Baton Rouge

71500

Investigational Site Number : 3000001, Heraklion

75010

Investigational Site Number : 2500005, Paris

76104

The Center For Cancer And Blood Disorders Site Number : 8400022, Fort Worth

88000

Investigational Site Number : 8040005, Uzhhorod

90404

UCLA Hematology Oncology Parkside Site Number : 8400024, Santa Monica

91031

Investigational Site Number : 3760002, Jerusalem

91910

Investigational Site Number : 4840006, Veracruz

93309

Comprehensive Blood and Cancer Center Site Number : 8400018, Bakersfield

94000

Investigational Site Number : 2500006, Créteil

94800

Investigational Site Number : 2500001, Villejuif

98405

Northwest Medical Specialties Site Number : 8400038, Tacoma

100021

Investigational Site Number : 1560001, Beijing

115478

Investigational Site Number : 6430003, Moscow

129090

Investigational Site Number : 6430005, Moscow

130021

Investigational Site Number : 1560015, Changchun

150081

Investigational Site Number : 1560005, Harbin

197758

Investigational Site Number : 6430002, Saint Petersburg

210029

Investigational Site Number : 1560011, Nanjing

230001

Investigational Site Number : 1560010, Hefei

230022

Investigational Site Number : 1560018, Hefei

250013

Investigational Site Number : 1560026, Jinan

276000

Investigational Site Number : 1560008, Linyi

300060

Investigational Site Number : 1560013, Tianjin

310016

Investigational Site Number : 1560023, Hangzhou

310022

Investigational Site Number : 1560002, Hangzhou

400030

Investigational Site Number : 1560024, Chongqing

410005

Investigational Site Number : 1560014, Changsha

430079

Investigational Site Number : 1560016, Wuhan

610041

Investigational Site Number : 1560025, Chengdu

650118

Investigational Site Number : 1560003, Kunming

830000

Investigational Site Number : 1560021, Ürümqi

90035903

Hospital de Clinicas de Porto Alegre - HCPA Site Number : 0760001, Porto Alegre

02115

Dana Farber Cancer Institute Site Number : 8400015, Boston

03756

Dartmouth Hitchcock Med Center Site Number : 8400013, Lebanon

07601

Hackensack University Medical Center Site Number : 8400025, Hackensack

05401

University Of Vermont Site Number : 8400026, Burlington

C1019ABS

Investigational Site Number : 0320008, CABA

1426ANZ

Investigational Site Number : 0320001, Buenos Aires

C1125ABD

Investigational Site Number : 0320006, Buenos Aires

B-6000

Investigational Site Number : 0560002, Charleroi

74605-070

Hospital Araujo Jorge Site Number : 0760005, Goiânia

90110-270

Hospital Mae de Deus Site Number : 0760002, Porto Alegre

15090-000

Hospital de Base Sao Jose do Rio Preto Site Number : 0760003, São José do Rio Preto

04014-002

Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760006, São Paulo

T2N 4N2

Investigational Site Number : 1240004, Calgary

N6A 5W9

Investigational Site Number : 1240003, London

H3T 1E2

Investigational Site Number : 1240006, Montreal

Unknown

Investigational Site Number : 1560031, Xuzhou

741 01

Investigational Site Number : 2030003, Nový Jičín

464-8681

Investigational Site Number : 3920002, Nagoya

277-8577

Investigational Site Number : 3920001, Kashiwa-shi

373-8550

Investigational Site Number : 3920009, Ota-shi

241-8515

Investigational Site Number : 3920006, Yokohama

540-0006

Investigational Site Number : 3920003, Osaka

362-0806

Investigational Site Number : 3920005, Kitaadachi-gun

104-0045

Investigational Site Number : 3920004, Chuo-ku

135-8550

Investigational Site Number : 3920008, Koto-ku

LV-1002

Investigational Site Number : 4280002, Riga

LV-1038

Investigational Site Number : 4280001, Riga

03100

Investigational Site Number : 4840005, México

61-866

Investigational Site Number : 6160003, Poznan

02-781

Investigational Site Number : 6160001, Warsaw

00917

Torre Hospital Auxilo Mutuo Site Number : 8400028, Ponce de Leon 735 Hato Rey

03080

Investigational Site Number : 4100001, Seoul

03722

Investigational Site Number : 4100004, Seoul

05505

Investigational Site Number : 4100003, Seoul

06351

Investigational Site Number : 4100002, Seoul

08035

Investigational Site Number : 7240006, Barcelona

08908

Investigational Site Number : 7240001, L'Hospitalet de Llobregat

08036

Investigational Site Number : 7240003, Barcelona

06200

Investigational Site Number : 7920004, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT04059484 - Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer | Biotech Hunter | Biotech Hunter