Clinical trial NCT04478266: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 1068
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria :

* Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment.
* Confirmed diagnosis of ER+/HER2- breast cancer.
* No prior systemic treatment for loco-regional recurrent or metastatic disease.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Participants should be willing to provide tumor tissue.
* Capable of giving informed consent.

Exclusion criteria:

* Known active brain metastases.
* Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD).
* Inadequate organ and marrow function.
* Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy.
* Pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods.
* Male participants who disagree to follow contraception.
* Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term.
* Participants with significant concomitant illness.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks)
measure: 12-month Progression-free Survival (PFS) Rate
timeFrame: Month 12
measure: Percentage of Participants With Objective Response
timeFrame: From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)
measure: Duration of Response (DOR)
timeFrame: From the date of first response of CR or PR until disease progression or death, or start of any anti-cancer therapy or data cut-off date, whichever comes first (maximum duration: 81 weeks)
measure: Percentage of Participants With Clinical Benefit
timeFrame: From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks)
measure: Progression-free Survival on Next Line of Therapy (PFS2)
timeFrame: From randomization to date first documented disease progression on the next systemic anti-cancer therapy, or death due to any cause, or data cut-off date, whichever comes first (maximum duration: 81 weeks)
measure: Pharmacokinetics: Plasma Concentrations of Amcenestrant
timeFrame: Cycle 1 Day 1: 3 hours (hr) post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose
measure: Pharmacokinetics: Plasma Concentrations of Palbociclib
timeFrame: Cycle 1 Day 1: 3 hr post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores
timeFrame: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores
timeFrame: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores
timeFrame: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
measure: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score
timeFrame: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
measure: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score
timeFrame: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
measure: Time to First Chemotherapy
timeFrame: From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks)
measure: Number of Participants With Hematological Abnormalities During the Treatment Period
timeFrame: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)
measure: Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period
timeFrame: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Investigational Site Number :8400075
state: Alabama
city: Glendale
country: United States
facility: Investigational Site Number :8400083
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number :8400066
state: Arizona
city: Fullerton
country: United States
facility: Investigational Site Number :8400038
state: California
city: Los Alamitos
country: United States
facility: Investigational Site Number :8400056
state: California
city: Santa Monica
country: United States
facility: Investigational Site Number :8400029
state: California
city: Denver
country: United States
facility: Investigational Site Number :8400025
state: Colorado
city: Lakeland
country: United States
facility: Investigational Site Number :8400059
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number :8400053
state: Florida
city: Palm Bay
country: United States
facility: Investigational Site Number :8400081
state: Florida
city: Athens
country: United States
facility: Investigational Site Number :8400055
state: Georgia
city: Atlanta
country: United States
facility: Investigational Site Number :8400016
state: Georgia
city: Savannah
country: United States
facility: Investigational Site Number :8400034
state: Georgia
city: Thomasville
country: United States
facility: Investigational Site Number :8400035
state: Georgia
city: Chicago
country: United States
facility: Investigational Site Number :8400039
state: Illinois
city: Fort Wayne
country: United States
facility: Investigational Site Number :8400008
state: Indiana
city: Iowa City
country: United States
facility: Investigational Site Number :8400006
state: Iowa
city: Westwood
country: United States
facility: Investigational Site Number :8400013
state: Kansas
city: Scarborough
country: United States
facility: Investigational Site Number :8400028
state: Maine
city: Boston
country: United States
facility: Investigational Site Number :8400017
state: Massachusetts
city: Danvers
country: United States
facility: Investigational Site Number :8400076
state: Massachusetts
city: Newton
country: United States
facility: Investigational Site Number :8400077
state: Massachusetts
city: Ann Arbor
country: United States
facility: Investigational Site Number :8400002
state: Michigan
city: Kansas City
country: United States
facility: Investigational Site Number :8400005
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number :8400004
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site Number :8400058
state: Nevada
city: New Brunswick
country: United States
facility: Investigational Site Number :8400015
state: New Jersey
city: Paramus
country: United States
facility: Investigational Site Number :8400024
state: New Jersey
city: New York
country: United States
facility: Investigational Site Number :8400010
state: New York
city: Stony Brook
country: United States
facility: Investigational Site Number :8400023
state: New York
city: Winston-Salem
country: United States
facility: Investigational Site Number :8400009
state: North Carolina
city: Tigard
country: United States
facility: Investigational Site Number :8400067
state: Oregon
city: Pittsburgh
country: United States
facility: Investigational Site Number :8400001
state: Pennsylvania
city: Austin
country: United States
facility: Investigational Site Number :8400073
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number :8400072
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number :8400070
state: Texas
city: Denton
country: United States
facility: Investigational Site Number :8400080
state: Texas
city: Houston
country: United States
facility: Investigational Site Number :8400061
state: Texas
city: Houston
country: United States
facility: Investigational Site Number :8400068
state: Texas
city: Plano
country: United States
facility: Investigational Site Number :8400084
state: Texas
city: The Woodlands
country: United States
facility: Investigational Site Number :8400086
state: Texas
city: Waco
country: United States
facility: Investigational Site Number :8400078
state: Texas
city: Webster
country: United States
facility: Investigational Site Number :8400082
state: Texas
city: Blacksburg
country: United States
facility: Investigational Site Number :8400085
state: Virginia
city: Winchester
country: United States
facility: Investigational Site Number :8400069
state: Virginia
city: Caba
country: Argentina
facility: Investigational Site Number :0320001
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number :0320005
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Investigational Site Number :0320008
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Investigational Site Number :0320006
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Investigational Site Number :0320010
state: Córdoba
city: Rosario
country: Argentina
facility: Investigational Site Number :0320002
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number :0320004
city: La Rioja
country: Argentina
facility: Investigational Site Number :0320003
city: Mar del Plata
country: Argentina
facility: Investigational Site Number :0320009
city: Salta
country: Argentina
facility: Investigational Site Number :0320007
city: Macquarie Park
country: Australia
facility: Investigational Site Number :0360004
state: New South Wales
city: Randwick
country: Australia
facility: Investigational Site Number :0360005
state: New South Wales
city: Wahroonga
country: Australia
facility: Investigational Site Number :0360003
state: New South Wales
city: Richmond
country: Australia
facility: Investigational Site Number :0360002
state: Victoria
city: Nedlands
country: Australia
facility: Investigational Site Number :0360001
state: Western Australia
city: Graz
country: Austria
facility: Investigational Site Number :0400001
city: Bruxelles
country: Belgium
facility: Investigational Site Number :0560003
city: Charleroi
country: Belgium
facility: Investigational Site Number :0560004
city: Leuven
country: Belgium
facility: Investigational Site Number :0560001
city: Namur
country: Belgium
facility: Investigational Site Number :0560002
city: Porto Alegre
country: Brazil
facility: Investigational Site Number :0760005
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Investigational Site Number :0760006
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Investigational Site Number :0760007
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Investigational Site Number :0760003
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number :0760004
city: São Paulo
country: Brazil
facility: Investigational Site Number :0760008
city: Burgas
country: Bulgaria
facility: Investigational Site Number :1000004
city: Dobrich
country: Bulgaria
facility: Investigational Site Number :1000005
city: Russe
country: Bulgaria
facility: Investigational Site Number :1000008
city: Sofia
country: Bulgaria
facility: Investigational Site Number :1000001
city: Kingston
country: Canada
facility: Investigational Site Number :1240004
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number :1240002
state: Ontario
city: Greenfield Park
country: Canada
facility: Investigational Site Number :1240007
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number :1240014
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number :1240005
state: Quebec
city: La Serena
country: Chile
facility: Investigational Site Number :1520005
state: Coquimbo
city: Temuco
country: Chile
facility: Investigational Site Number :1520004
state: La Araucanía
city: Talca
country: Chile
facility: Investigational Site Number :1520009
state: Maule
city: Santaigo
country: Chile
facility: Investigational Site Number :1520011
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number :1520006
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number :1520002
state: Reg Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Investigational Site Number :1520001
state: Valparaíso
city: Santiago de Chile
country: Chile
facility: Investigational Site Number :1520003
city: Santiago
country: Chile
facility: Investigational Site Number :1520007
city: Baoding
country: China
facility: Investigational Site Number :1560038
city: Beijing
country: China
facility: Investigational Site Number :1560008
city: Beijing
country: China
facility: Investigational Site Number :1560035
city: Changchun
country: China
facility: Investigational Site Number :1560003
city: Changchun
country: China
facility: Investigational Site Number :1560036
city: Chengdu
country: China
facility: Investigational Site Number :1560013
city: Chongqing
country: China
facility: Investigational Site Number :1560019
city: Dalian
country: China
facility: Investigational Site Number :1560031
city: Dalian
country: China
facility: Investigational Site Number :1560021
city: Deyang
country: China
facility: Investigational Site Number :1560054
city: Fuzhou
country: China
facility: Investigational Site Number :1560043
city: Guangzhou
country: China
facility: Investigational Site Number :1560025
city: Hangzhou
country: China
facility: Investigational Site Number :1560006
city: Hangzhou
country: China
facility: Investigational Site Number :1560007
city: Hangzhou
country: China
facility: Investigational Site Number :1560002
city: Hangzhou
country: China
facility: Investigational Site Number :1560005
city: Harbin
country: China
facility: Investigational Site Number :1560011
city: Hefei
country: China
facility: Investigational Site Number :1560041
city: Jinan
country: China
facility: Investigational Site Number :1560018
city: Jinan
country: China
facility: Investigational Site Number :1560046
city: Jining
country: China
facility: Investigational Site Number :1560051
city: Linyi
country: China
facility: Investigational Site Number :1560017
city: Luoyang
country: China
facility: Investigational Site Number :1560055
city: Neijiang
country: China
facility: Investigational Site Number :1560048
city: Shanghai
country: China
facility: Investigational Site Number :1560001
city: Shaoguan
country: China
facility: Investigational Site Number :1560037
city: Tianjin
country: China
facility: Investigational Site Number :1560028
city: Wuhan
country: China
facility: Investigational Site Number :1560033
city: Wuhan
country: China
facility: Investigational Site Number :1560024
city: Xi'an
country: China
facility: Investigational Site Number :1560045
city: Xi'An
country: China
facility: Investigational Site Number :1560044
city: Xuzhou
country: China
facility: Investigational Site Number :1560027
city: Yantai
country: China
facility: Investigational Site Number :1560049
city: Zhengzhou
country: China
facility: Investigational Site Number :1560022
city: Brno
country: Czechia
facility: Investigational Site Number :2030001
city: Praha 2
country: Czechia
facility: Investigational Site Number :2030002
city: Helsinki
country: Finland
facility: Investigational Site Number :2460001
city: Tampere
country: Finland
facility: Investigational Site Number :2460002
city: Turku
country: Finland
facility: Investigational Site Number :2460003
city: Nice
country: France
facility: Investigational Site Number :2500009
city: Paris
country: France
facility: Investigational Site Number :2500003
city: Paris
country: France
facility: Investigational Site Number :2500001
city: Poitiers
country: France
facility: Investigational Site Number :2500006
city: Saint Cloud
country: France
facility: Investigational Site Number :2500007
city: Saint-Herblain
country: France
facility: Investigational Site Number :2500002
city: Strasbourg
country: France
facility: Investigational Site Number :2500010
city: TOULOUSE Cedex 9
country: France
facility: Investigational Site Number :2500005
city: Villejuif
country: France
facility: Investigational Site Number :2500004
city: Batumi
country: Georgia
facility: Investigational Site Number :2680005
city: Kutaisi
country: Georgia
facility: Investigational Site Number :2680006
city: Tbilisi
country: Georgia
facility: Investigational Site Number :2680001
city: Tbilisi
country: Georgia
facility: Investigational Site Number :2680002
city: Tbilisi
country: Georgia
facility: Investigational Site Number :2680004
city: Tbilisi
country: Georgia
facility: Investigational Site Number :2680007
city: Tbilisi
country: Georgia
facility: Investigational Site Number :2680003
city: Bottrop
country: Germany
facility: Investigational Site Number :2760006
city: Münster
country: Germany
facility: Investigational Site Number :2760003
city: Oldenburg in Holstein
country: Germany
facility: Investigational Site Number :2760007
city: Ulm
country: Germany
facility: Investigational Site Number :2760001
city: Budapest
country: Hungary
facility: Investigational Site Number :3480008
city: Gyula
country: Hungary
facility: Investigational Site Number :3480011
city: Győr
country: Hungary
facility: Investigational Site Number :3480005
city: Kaposvár
country: Hungary
facility: Investigational Site Number :3480003
city: Kecskemét
country: Hungary
facility: Investigational Site Number :3480009
city: Miskolc
country: Hungary
facility: Investigational Site Number :3480010
city: Nyíregyháza
country: Hungary
facility: Investigational Site Number :3480001
city: Meldola (FC)
country: Italy
facility: Investigational Site Number :3800008
state: Emilia-Romagna
city: Rozzano
country: Italy
facility: Investigational Site Number :3800003
state: Milano
city: Monza
country: Italy
facility: Investigational Site Number :3800007
state: Monza E Brianza
city: Bologna
country: Italy
facility: Investigational Site Number :3800010
city: Milano
country: Italy
facility: Investigational Site Number :3800004
city: Milano
country: Italy
facility: Investigational Site Number :3800002
city: Napoli
country: Italy
facility: Investigational Site Number :3800006
city: Prato
country: Italy
facility: Investigational Site Number :3800005
city: Nagoya-shi
country: Japan
facility: Investigational Site Number :3920016
state: Aichi
city: Nagoya-shi
country: Japan
facility: Investigational Site Number :3920007
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Investigational Site Number :3920002
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Investigational Site Number :3920009
state: Ehime
city: Kurume-shi
country: Japan
facility: Investigational Site Number :3920019
state: Fukuoka
city: Takasaki-shi
country: Japan
facility: Investigational Site Number :3920017
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Investigational Site Number :3920010
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Investigational Site Number :3920001
state: Hokkaido
city: Kagoshima-shi
country: Japan
facility: Investigational Site Number :3920012
state: Kagoshima
city: Yokohama-shi
country: Japan
facility: Investigational Site Number :3920014
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Investigational Site Number :3920006
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Investigational Site Number :3920020
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: Investigational Site Number :3920022
state: Miyazaki
city: Osaka-shi
country: Japan
facility: Investigational Site Number :3920008
state: Osaka
city: Osaka-shi
country: Japan
facility: Investigational Site Number :3920018
state: Osaka
city: Hidaka-shi
country: Japan
facility: Investigational Site Number :3920013
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Investigational Site Number :3920021
state: Shizuoka
city: Koto-ku
country: Japan
facility: Investigational Site Number :3920003
state: Tokyo
city: Meguro-ku
country: Japan
facility: Investigational Site Number :3920015
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Investigational Site Number :3920005
state: Tokyo
city: Goyang-si
country: Korea, Republic of
facility: Investigational Site Number :4100006
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number :4100005
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100007
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100004
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100003
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100002
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100001
state: Seoul-teukbyeolsi
city: Seochogu
country: Korea, Republic of
facility: Investigational Site Number :4100009
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Investigational Site Number :4100008
city: Arnhem
country: Netherlands
facility: Investigational Site Number :5280006
city: Delft
country: Netherlands
facility: Investigational Site Number :5280005
city: Maastricht
country: Netherlands
facility: Investigational Site Number :5280001
city: Tomaszow Mazowiecki
country: Poland
facility: Investigational Site Number :6160002
state: Lódzkie
city: Poznan
country: Poland
facility: Investigational Site Number :6160007
state: Wielkopolskie
city: Almada
country: Portugal
facility: Investigational Site Number :6200005
city: Lisboa
country: Portugal
facility: Investigational Site Number :6200001
city: Porto
country: Portugal
facility: Investigational Site Number :6200002
city: Arkhangelsk
country: Russian Federation
facility: Investigational Site Number :6430007
city: Krasnogorskiy District
country: Russian Federation
facility: Investigational Site Number :6430004
city: Moscow Region
country: Russian Federation
facility: Investigational Site Number :6430009
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430008
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430003
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430005
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430006
city: Saint -Petersburg
country: Russian Federation
facility: Investigational Site Number :6430001
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number :6430010
city: Singapore
country: Singapore
facility: Investigational Site Number :7020002
city: Singapore
country: Singapore
facility: Investigational Site Number :7020004
city: Singapore
country: Singapore
facility: Investigational Site Number :7020001
city: Cape Town
country: South Africa
facility: Investigational Site Number :7100004
city: Johannesburg
country: South Africa
facility: Investigational Site Number :7100006
city: Barcelona
country: Spain
facility: Investigational Site Number :7240011
state: Barcelona [Barcelona]
city: Barcelona / Sabadell
country: Spain
facility: Investigational Site Number :7240008
state: Castilla Y León
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number :7240003
state: Galicia [Galicia]
city: Madrid / Madrid
country: Spain
facility: Investigational Site Number :7240006
state: Madrid, Comunidad De
city: Madrid / Madrid
country: Spain
facility: Investigational Site Number :7240002
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Investigational Site Number :7240004
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Investigational Site Number :7240005
state: Valenciana, Comunidad
city: Madrid
country: Spain
facility: Investigational Site Number :7240001
city: Málaga
country: Spain
facility: Investigational Site Number :7240007
city: Valencia
country: Spain
facility: Investigational Site Number :7240009
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number :1580007
city: Tainan
country: Taiwan
facility: Investigational Site Number :1580002
city: Taipei
country: Taiwan
facility: Investigational Site Number :1580001
city: Taipei
country: Taiwan
facility: Investigational Site Number :1580003
city: Adana
country: Turkey
facility: Investigational Site Number :7920006
city: Ankara
country: Turkey
facility: Investigational Site Number :7920008
city: Ankara
country: Turkey
facility: Investigational Site Number :7920009
city: Antalya
country: Turkey
facility: Investigational Site Number :7920007
city: Bornova
country: Turkey
facility: Investigational Site Number :7920005
city: Diyarbakır
country: Turkey
facility: Investigational Site Number :7920013
city: Edirne
country: Turkey
facility: Investigational Site Number :7920003
city: Istanbul
country: Turkey
facility: Investigational Site Number :7920001
city: Istanbul
country: Turkey
facility: Investigational Site Number :7920011
city: Istanbul
country: Turkey
facility: Investigational Site Number :7920004
city: İzmir
country: Turkey
facility: Investigational Site Number :7920012
city: Kocaeli
country: Turkey
facility: Investigational Site Number :7920010
city: Malatya
country: Turkey
facility: Investigational Site Number :7920002
city: Kharkiv
country: Ukraine
facility: Investigational Site Number :8040004
city: Kharkiv
country: Ukraine
facility: Investigational Site Number :8040010
city: Kryvyi Rih
country: Ukraine
facility: Investigational Site Number :8040001
city: Odesa
country: Ukraine
facility: Investigational Site Number :8040002
city: Vinnytsia
country: Ukraine
facility: Investigational Site Number :8040007
city: Glasgow
country: United Kingdom
facility: Investigational Site Number :8260001
state: Central Bedfordshire
city: Edinburgh
country: United Kingdom
facility: Investigational Site Number :8260002
state: Edinburgh, City Of
city: Blackburn
country: United Kingdom
facility: Investigational Site Number :8260005
state: Lancashire
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Bardia A, Cortes J, Hurvitz SA, Delaloge S, Iwata H, Shao ZM, Kanagavel D, Cohen P, Liu Q, Cartot-Cotton S, Pelekanou V, O'Shaughnessy J. AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2022 Mar 15;14:17588359221083956. doi: 10.1177/17588359221083956. eCollection 2022.