Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

February 4, 2020

Primary Completion Date

April 30, 2021

Study Completion Date

May 28, 2021

Conditions
Breast Cancer
Interventions
DRUG

Amcenestrant (SAR439859)

Pharmaceutical form: Capsules, Route of administration: Oral

DRUG

Letrozole

Pharmaceutical form: Tablets, Route of administration: Oral

Trial Locations (32)

3000

Investigational Site Number 0560001, Leuven

5000

Investigational Site Number 0560002, Namur

14004

Investigational Site Number 7240003, Córdoba

20132

Investigational Site Number 3800002, Milan

20141

Investigational Site Number 3800001, Milan

21029

Investigational Site Number 8040002, Vinnytsia

27157

Investigational Site Number 8400016, Winston-Salem

28041

Investigational Site Number 7240001, Madrid

31059

Investigational Site Number 2500003, Toulouse

44093

Investigational Site Number 2500001, Nantes

46010

Investigational Site Number 7240002, Valencia

46804

Investigational Site Number 8400018, Fort Wayne

47014

Investigational Site Number 3800004, Meldola

61166

Investigational Site Number 8040004, Kharkiv

68506

Investigational Site Number 8400005, Lincoln

69040

Investigational Site Number 8040005, Zaporizhzhya

75010

Investigational Site Number 2500004, Paris

85724

Investigational Site Number 8400014, Tucson

88000

Investigational Site Number 8040001, Uzhhorod

90095

Investigational Site Number 8400010, Los Angeles

92210

Investigational Site Number 2500002, Saint-Cloud

98405

Investigational Site Number 8400012, Tacoma

117186

Investigational Site Number 6430006, Moscow

119991

Investigational Site Number 6430004, Moscow

194156

Investigational Site Number 6430003, Saint Petersburg

195271

Investigational Site Number 6430007, Saint Petersburg

197758

Investigational Site Number 6430002, Saint Petersburg

Unknown

Investigational Site Number 3920002, Osaka

Investigational Site Number 3920003, Sapporo

Investigational Site Number 3920001, Yokohama

00917

Investigational Site Number 8400007, Hato Rey

08003

Investigational Site Number 7240005, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT04191382 - Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer | Biotech Hunter | Biotech Hunter