AzTrials
AzTrials

Breast CancerPhase 3AMEERA-5NCT04478266

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

A Phase 3 study testing SAR439859, Palbociclib and Letrozole in people with Breast Cancer, run by Sanofi at 249 sites in 30 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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-)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
SAR439859, Palbociclib and Letrozole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,068 participants
Where
249 sitesin 30 countries
Study dates
14 Oct 2020to 26 May 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

249 sites in 30 countries.

249 sites in 30 countries

United States45 sites

  • Investigational Site Number :8400002

    Ann Arbor, Michigan, 48109

  • Investigational Site Number :8400055

    Athens, Georgia, 30607

  • Investigational Site Number :8400016

    Atlanta, Georgia, 30342

  • Investigational Site Number :8400073

    Austin, Texas, 78745

  • Investigational Site Number :8400085

    Blacksburg, Virginia, 24060

  • Investigational Site Number :8400017

    Boston, Massachusetts, 02114

  • Investigational Site Number :8400039

    Chicago, Illinois, 60612

  • Investigational Site Number :8400072

    Dallas, Texas, 75231

  • Investigational Site Number :8400070

    Dallas, Texas, 75246

  • Investigational Site Number :8400076

    Danvers, Massachusetts, 01923

  • Investigational Site Number :8400075

    Daphne, Alabama, 36526

  • Investigational Site Number :8400080

    Denton, Texas, 76021

  • Investigational Site Number :8400025

    Denver, Colorado, 80262

  • Investigational Site Number :8400008

    Fort Wayne, Indiana, 46804

  • Investigational Site Number :8400038

    Fullerton, California, 92835

  • Investigational Site Number :8400083

    Glendale, Arizona, 85308

  • Investigational Site Number :8400061

    Houston, Texas, 77024

  • Investigational Site Number :8400068

    Houston, Texas, 77024

  • Investigational Site Number :8400006

    Iowa City, Iowa, 52242

  • Investigational Site Number :8400005

    Kansas City, Missouri, 64111

  • Investigational Site Number :8400059

    Lakeland, Florida, 33805

  • Investigational Site Number :8400058

    Las Vegas, Nevada, 89102

  • Investigational Site Number :8400056

    Los Alamitos, California, 90720

  • Investigational Site Number :8400015

    New Brunswick, New Jersey, 08901-1914

  • Investigational Site Number :8400010

    New York, New York, 10016

  • Investigational Site Number :8400077

    Newton, Massachusetts, 02463

  • Investigational Site Number :8400053

    Orlando, Florida, 32804

  • Investigational Site Number :8400081

    Palm Bay, Florida, 32901

  • Investigational Site Number :8400024

    Paramus, New Jersey, 00000

  • Investigational Site Number :8400001

    Pittsburgh, Pennsylvania, 15232

  • Investigational Site Number :8400084

    Plano, Texas, 75093

  • Investigational Site Number :8400029

    Santa Monica, California, 90404

  • Investigational Site Number :8400034

    Savannah, Georgia, 31405

  • Investigational Site Number :8400028

    Scarborough, Maine, 04074-9308

  • Investigational Site Number :8400004

    St Louis, Missouri, 63141

  • Investigational Site Number :8400023

    Stony Brook, New York, 11794-8121

  • Investigational Site Number :8400086

    The Woodlands, Texas, 77380

  • Investigational Site Number :8400035

    Thomasville, Georgia, 31792

  • Investigational Site Number :8400067

    Tigard, Oregon, 97223

  • Investigational Site Number :8400066

    Tucson, Arizona, 85712

  • Investigational Site Number :8400078

    Waco, Texas, 76712

  • Investigational Site Number :8400082

    Webster, Texas, 77598

  • Investigational Site Number :8400013

    Westwood, Kansas, 66205-2003

  • Investigational Site Number :8400069

    Winchester, Virginia, 22601

  • Investigational Site Number :8400009

    Winston-Salem, North Carolina, 27157

Other trials in United States

China34 sites

  • Investigational Site Number :1560038

    Baoding, 071000

  • Investigational Site Number :1560008

    Beijing, 100142

  • Investigational Site Number :1560035

    Beijing, 100730

  • Investigational Site Number :1560003

    Changchun, 130021

  • Investigational Site Number :1560036

    Changchun, 130041

  • Investigational Site Number :1560013

    Chengdu, 610041

  • Investigational Site Number :1560019

    Chongqing, 400030

  • Investigational Site Number :1560031

    Dalian, 116011

  • Investigational Site Number :1560021

    Dalian, 116027

  • Investigational Site Number :1560054

    Deyang, 618000

  • Investigational Site Number :1560043

    Fuzhou, 354200

  • Investigational Site Number :1560025

    Guangzhou, 510080

  • Investigational Site Number :1560006

    Hangzhou, 310003

  • Investigational Site Number :1560007

    Hangzhou, 310009

  • Investigational Site Number :1560002

    Hangzhou, 310016

  • Investigational Site Number :1560005

    Hangzhou, 310022

  • Investigational Site Number :1560011

    Harbin, 150081

  • Investigational Site Number :1560041

    Hefei, 233004

  • Investigational Site Number :1560018

    Jinan, 250013

  • Investigational Site Number :1560046

    Jinan, 250117

  • Investigational Site Number :1560051

    Jining

  • Investigational Site Number :1560017

    Linyi, 276000

  • Investigational Site Number :1560055

    Luoyang, 471003

  • Investigational Site Number :1560048

    Neijiang, 641003

  • Investigational Site Number :1560001

    Shanghai, 200032

  • Investigational Site Number :1560037

    Shaoguan, 512025

  • Investigational Site Number :1560028

    Tianjin, 300060

  • Investigational Site Number :1560033

    Wuhan, 430060

  • Investigational Site Number :1560024

    Wuhan, 430079

  • Investigational Site Number :1560045

    Xi'an, 710004

  • Investigational Site Number :1560044

    Xi'an, 710061

  • Investigational Site Number :1560027

    Xuzhou, 221009

  • Investigational Site Number :1560049

    Yantai, 264000

  • Investigational Site Number :1560022

    Zhengzhou, 450008

Other trials in China

Japan20 sites

  • Investigational Site Number :3920013

    Hidaka-shi, Saitama, 350-1241

  • Investigational Site Number :3920010

    Hiroshima, Hiroshima, 730-8518

  • Investigational Site Number :3920012

    Kagoshima, Kagoshima-ken, 892-0833

  • Investigational Site Number :3920002

    Kashiwa-shi, Chiba, 277-8577

  • Investigational Site Number :3920003

    Koto-ku, Tokyo, 135-8550

  • Investigational Site Number :3920019

    Kurume-shi, Fukuoka, 830-0013

  • Investigational Site Number :3920009

    Matsuyama, Ehime, 791-0280

  • Investigational Site Number :3920015

    Meguro-ku, Tokyo, 152-8902

  • Investigational Site Number :3920022

    Miyazaki, Miyazaki, 880-8510

  • Investigational Site Number :3920016

    Nagoya, Aichi-ken, 460-0001

  • Investigational Site Number :3920007

    Nagoya, Aichi-ken, 464-8681

  • Investigational Site Number :3920008

    Osaka, Osaka, 540-0006

  • Investigational Site Number :3920018

    Osaka, Osaka, 553-0003

  • Investigational Site Number :3920001

    Sapporo, Hokkaido, 003-0804

  • Investigational Site Number :3920020

    Sendai, Miyagi, 980-0803

  • Investigational Site Number :3920005

    Shinagawa-ku, Tokyo, 142-8666

  • Investigational Site Number :3920021

    Shizuoka, Shizuoka, 420-8527

  • Investigational Site Number :3920017

    Takasaki-shi, Gunma, 370-0829

  • Investigational Site Number :3920014

    Yokohama, Kanagawa, 222-0036

  • Investigational Site Number :3920006

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Turkey (Türkiye)13 sites

  • Investigational Site Number :7920006

    Adana, 01120

  • Investigational Site Number :7920008

    Ankara, 06100

  • Investigational Site Number :7920009

    Ankara, 06200

  • Investigational Site Number :7920007

    Antalya, 07070

  • Investigational Site Number :7920005

    Bornova, 35100

  • Investigational Site Number :7920013

    Diyarbakır, 21100

  • Investigational Site Number :7920003

    Edirne, 22030

  • Investigational Site Number :7920001

    Istanbul, 34214

  • Investigational Site Number :7920011

    Istanbul, 34457

  • Investigational Site Number :7920004

    Istanbul, 34722

  • Investigational Site Number :7920012

    Izmir, 0000

  • Investigational Site Number :7920010

    Kocaeli, 41380

  • Investigational Site Number :7920002

    Malatya, 44280

Other trials in Turkey (Türkiye)

Argentina10 sites

  • Investigational Site Number :0320004

    Buenos Aires, C1125ABD

  • Investigational Site Number :0320001

    CABA, Buenos Aires, C1012AAR

  • Investigational Site Number :0320005

    CABA, Buenos Aires, C1019ABS

  • Investigational Site Number :0320008

    Capital Federal, Buenos Aires, C1417DTB

  • Investigational Site Number :0320010

    Córdoba, Córdoba Province, 5000

  • Investigational Site Number :0320003

    La Rioja, 5300

  • Investigational Site Number :0320009

    Mar del Plata, B7600FYK

  • Investigational Site Number :0320006

    Pergamino, Buenos Aires, B2700CPM

  • Investigational Site Number :0320002

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number :0320007

    Salta, 4400

Other trials in Argentina

Spain10 sites

  • Investigational Site Number :7240011

    Barcelona, Barcelona [Barcelona], 08017

  • Investigational Site Number :7240008

    Barcelona / Sabadell, Castille and León, 08208

  • Investigational Site Number :7240004

    Madrid, Madrid, Comunidad de, 28046

  • Investigational Site Number :7240001

    Madrid, 28041

  • Investigational Site Number :7240006

    Madrid / Madrid, Madrid, Comunidad de, 28007

  • Investigational Site Number :7240002

    Madrid / Madrid, Madrid, Comunidad de, 28050

  • Investigational Site Number :7240007

    Málaga, 29010

  • Investigational Site Number :7240003

    Santiago de Compostela, Galicia [Galicia], 15706

  • Investigational Site Number :7240005

    Valencia, Valenciana, Comunidad, 46010

  • Investigational Site Number :7240009

    Valencia, 46015

Other trials in Spain

Chile9 sites

  • Investigational Site Number :1520005

    La Serena, Coquimbo Region, 1720430

  • Investigational Site Number :1520011

    Santaigo, Reg Metropolitana de Santiago, 8241470

  • Investigational Site Number :1520006

    Santiago, Reg Metropolitana de Santiago, 7650568

  • Investigational Site Number :1520002

    Santiago, Reg Metropolitana de Santiago, 8420383

  • Investigational Site Number :1520007

    Santiago, 7500921

  • Investigational Site Number :1520003

    Santiago

  • Investigational Site Number :1520009

    Talca, Maule Region

  • Investigational Site Number :1520004

    Temuco, La Araucanía, 4810561

  • Investigational Site Number :1520001

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

France9 sites

  • Investigational Site Number :2500009

    Nice, 06189

  • Investigational Site Number :2500003

    Paris, 75010

  • Investigational Site Number :2500001

    Paris, 75248

  • Investigational Site Number :2500006

    Poitiers, 86021

  • Investigational Site Number :2500007

    Saint-Cloud, 92210

  • Investigational Site Number :2500002

    Saint-Herblain, 44805

  • Investigational Site Number :2500010

    Strasbourg, 67033

  • Investigational Site Number :2500005

    Toulouse, 31059

  • Investigational Site Number :2500004

    Villejuif, 94800

Other trials in France

Russia9 sites

  • Investigational Site Number :6430007

    Arkhangelsk, 163045

  • Investigational Site Number :6430004

    Krasnogorskiy District, 143423

  • Investigational Site Number :6430008

    Moscow, 115478

  • Investigational Site Number :6430003

    Moscow, 117186

  • Investigational Site Number :6430005

    Moscow, 117997

  • Investigational Site Number :6430006

    Moscow, 129090

  • Investigational Site Number :6430009

    Moscow Region, 143442

  • Investigational Site Number :6430001

    Saint Petersburg, 197758

  • Investigational Site Number :6430010

    Saint Petersburg, 199034

Other trials in Russia

South Korea9 sites

  • Investigational Site Number :4100006

    Goyang-si, Gyeonggi-do, 10408

  • Investigational Site Number :4100009

    Seochogu, 6591

  • Investigational Site Number :4100005

    Seongnam-si, Gyeonggi-do, 463-707

  • Investigational Site Number :4100008

    Seongnam-si, Gyeonggi-do, 13496

  • Investigational Site Number :4100007

    Seoul, Seoul-teukbyeolsi, 02841

  • Investigational Site Number :4100004

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number :4100003

    Seoul, Seoul-teukbyeolsi, 110-744

  • Investigational Site Number :4100002

    Seoul, Seoul-teukbyeolsi, 135-710

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 138-878

Other trials in South Korea

Italy8 sites

  • Investigational Site Number :3800010

    Bologna, 40138

  • Investigational Site Number :3800008

    Meldola (FC), Emilia-Romagna, 47014

  • Investigational Site Number :3800004

    Milan, 20132

  • Investigational Site Number :3800002

    Milan, 20141

  • Investigational Site Number :3800007

    Monza, Monza E Brianza, 20052

  • Investigational Site Number :3800006

    Naples, 80131

  • Investigational Site Number :3800005

    Prato, 59100

  • Investigational Site Number :3800003

    Rozzano, Milano, 20089

Other trials in Italy

Georgia7 sites

  • Investigational Site Number :2680005

    Batumi, 6000

  • Investigational Site Number :2680006

    Kutaisi, 4600

  • Investigational Site Number :2680001

    Tbilisi, 0112

  • Investigational Site Number :2680002

    Tbilisi, 0144

  • Investigational Site Number :2680004

    Tbilisi, 0159

  • Investigational Site Number :2680007

    Tbilisi, 0159

  • Investigational Site Number :2680003

    Tbilisi, 0168

Other trials in Georgia

Hungary7 sites

  • Investigational Site Number :3480008

    Budapest, 1115

  • Investigational Site Number :3480005

    Győr, 9023

  • Investigational Site Number :3480011

    Gyula, 5700

  • Investigational Site Number :3480003

    Kaposvár, 7400

  • Investigational Site Number :3480009

    Kecskemét, 6000

  • Investigational Site Number :3480010

    Miskolc, 3526

  • Investigational Site Number :3480001

    Nyíregyháza, 4400

Other trials in Hungary

Brazil6 sites

  • Investigational Site Number :0760005

    Porto Alegre, Rio Grande do Sul, 90035 003

  • Investigational Site Number :0760006

    Porto Alegre, Rio Grande do Sul, 91350-250

  • Investigational Site Number :0760004

    Rio de Janeiro, 20230-130

  • Investigational Site Number :0760007

    São Paulo, São Paulo, 01509-900

  • Investigational Site Number :0760003

    São Paulo, São Paulo, 04014-002

  • Investigational Site Number :0760008

    São Paulo, 04321-120

Other trials in Brazil

Australia5 sites

  • Investigational Site Number :0360004

    Macquarie Park, New South Wales, 2109

  • Investigational Site Number :0360001

    Nedlands, Western Australia, 6009

  • Investigational Site Number :0360005

    Randwick, New South Wales, 2031

  • Investigational Site Number :0360002

    Richmond, Victoria, 3121

  • Investigational Site Number :0360003

    Wahroonga, New South Wales, 2076

Other trials in Australia

Canada5 sites

  • Investigational Site Number :1240007

    Greenfield Park, Quebec, J4V 2H1

  • Investigational Site Number :1240004

    Kingston, Ontario, K7L 2V7

  • Investigational Site Number :1240014

    Montreal, Quebec, H3T 1S6

  • Investigational Site Number :1240005

    Montreal, Quebec, H4A 3J1

  • Investigational Site Number :1240002

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Ukraine5 sites

  • Investigational Site Number :8040004

    Kharkiv, 61103

  • Investigational Site Number :8040010

    Kharkiv, 61166

  • Investigational Site Number :8040001

    Kryvyi Rih, 50048

  • Investigational Site Number :8040002

    Odesa, 65025

  • Investigational Site Number :8040007

    Vinnytsia, 21029

Other trials in Ukraine

Belgium4 sites

  • Investigational Site Number :0560003

    Brussels, BE-1200

  • Investigational Site Number :0560004

    Charleroi, B-6000

  • Investigational Site Number :0560001

    Leuven, 3000

  • Investigational Site Number :0560002

    Namur, 5000

Other trials in Belgium

Bulgaria4 sites

  • Investigational Site Number :1000004

    Burgas, 8000

  • Investigational Site Number :1000005

    Dobrich

  • Investigational Site Number :1000008

    Rousse, 7002

  • Investigational Site Number :1000001

    Sofia, 1797

Other trials in Bulgaria

Germany4 sites

  • Investigational Site Number :2760006

    Bottrop, 46236

  • Investigational Site Number :2760003

    Münster, 48149

  • Investigational Site Number :2760007

    Oldenburg in Holstein, 23758

  • Investigational Site Number :2760001

    Ulm, 89075

Other trials in Germany

Taiwan4 sites

  • Investigational Site Number :1580007

    Kaohsiung City, 807

  • Investigational Site Number :1580002

    Tainan

  • Investigational Site Number :1580001

    Taipei, 100

  • Investigational Site Number :1580003

    Taipei, 10449

Other trials in Taiwan

Finland3 sites

  • Investigational Site Number :2460001

    Helsinki, 00029

  • Investigational Site Number :2460002

    Tampere, 33520

  • Investigational Site Number :2460003

    Turku, FIN-20520

Other trials in Finland

Netherlands3 sites

  • Investigational Site Number :5280006

    Arnhem, 6815 AD

  • Investigational Site Number :5280005

    Delft, 2625 AD

  • Investigational Site Number :5280001

    Maastricht, 6229 HX

Other trials in Netherlands

Portugal3 sites

  • Investigational Site Number :6200005

    Almada, 2801-951

  • Investigational Site Number :6200001

    Lisbon, 1649-035

  • Investigational Site Number :6200002

    Porto, 4200-319

Other trials in Portugal

Singapore3 sites

  • Investigational Site Number :7020002

    Singapore, 119228

  • Investigational Site Number :7020004

    Singapore, 169610

  • Investigational Site Number :7020001

    Singapore, 329563

Other trials in Singapore

United Kingdom3 sites

  • Investigational Site Number :8260005

    Blackburn, Lancashire, BB2 3HH

  • Investigational Site Number :8260002

    Edinburgh, Edinburgh, City of, EH4 2XU

  • Investigational Site Number :8260001

    Glasgow, Central Bedfordshire, G12 0YN

Other trials in United Kingdom

Czechia2 sites

  • Investigational Site Number :2030001

    Brno, 65653

  • Investigational Site Number :2030002

    Prague, 12808

Other trials in Czechia

Poland2 sites

  • Investigational Site Number :6160007

    Poznan, Greater Poland Voivodeship, 61-866

  • Investigational Site Number :6160002

    Tomaszów Mazowiecki, Lódzkie, 97-200

Other trials in Poland

South Africa2 sites

  • Investigational Site Number :7100004

    Cape Town, 7570

  • Investigational Site Number :7100006

    Johannesburg, 1709

Other trials in South Africa

Austria1 site

  • Investigational Site Number :0400001

    Graz, 8036

Other trials in Austria

About this study

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

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.

Read more

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.
Read the detailed description

Study duration per participant was approximately 59 months, which includes a 33- month treatment period.

Conditions
Breast Cancer
Being tested
Amcenestrant-matching placebo, SAR439859, Palbociclib, Letrozole, Goserelin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amcenestrant-matching placeboDrug

    Pharmaceutical form: Tablets Route of Administration: Oral

  • SAR439859Drug

    Also called Amcenestrant

    Pharmaceutical form: Tablets Route of Administration: Oral

  • PalbociclibDrug

    Also called Ibrance

    Pharmaceutical form: Capsules/Tablets Route of Administration: Oral

  • LetrozoleDrug

    Pharmaceutical form: Capsules Route of Administration: Orally

  • GoserelinDrug

    Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

  • Letrozole-matching placeboDrug

    Pharmaceutical form: Capsules Route of Administration: Orally

Study groups in NCT04478266
Study groupRoleWhat they receive
Letrozole + PalbociclibActive comparatorParticipants received letrozole 2.5 milligrams (mg) capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg orally (PO), once daily (QD) from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.
Receives: Drug: Amcenestrant-matching placebo; Drug: Palbociclib; Drug: Letrozole; Drug: Goserelin
Amcenestrant + PalbociclibExperimentalParticipants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death, or study cut-off date, whichever comes first (maximum exposure: 109 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.
Receives: Drug: SAR439859; Drug: Palbociclib; Drug: Goserelin; Drug: Letrozole-matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.

    Measured: 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 (16)

  1. Overall Survival (OS)

    OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.

    Measured: From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks)

  2. 12-month Progression-free Survival (PFS) Rate

    Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization.

    Measured: Month 12

  3. Percentage of Participants With Objective Response

    Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.

    Measured: 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)

  4. Duration of Response (DOR)

    DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.

    Measured: 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)

  5. Percentage of Participants With Clinical Benefit

    Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions \& normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.

    Measured: From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks)

  6. Progression-free Survival on Next Line of Therapy (PFS2)

    PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.

    Measured: 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)

  7. Pharmacokinetics: Plasma Concentrations of Amcenestrant

    Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol.

    Measured: 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

  8. Pharmacokinetics: Plasma Concentrations of Palbociclib

    Palbociclib plasma concentrations at specified time points were reported.

    Measured: 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

  9. Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores

    EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy \& assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, \& Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) \& GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \& GHS/QoL=higher level of functioning, \& higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported in this outcome measure.

    Measured: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])

  10. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores

    QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact \& side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales \& single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) \& 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, \& upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean \& SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value \& stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported.

    Measured: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])

  11. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores

    EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported.

    Measured: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])

  12. 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

    EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for VAS was reported in this outcome measure.

    Measured: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])

  13. 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

    EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) \& VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, \& extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state \& lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for health utility index value score was reported in this outcome measure.

    Measured: Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])

  14. Time to First Chemotherapy

    Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression.

    Measured: From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks)

  15. Number of Participants With Hematological Abnormalities During the Treatment Period

    Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment.

    Measured: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)

  16. Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period

    Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure.

    Measured: From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start14 Oct 2020
  3. Primary completion28 Jun 2022
  4. Study completion26 May 2023

Why it stopped: The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,068 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04478266
Sponsor's protocol ID
EFC15935
Other IDs
2020-001824-33, U1111-1233-0486
Acronym
AMEERA-5
Status last verified
Sep 2025
First submitted
10 Jul 2020
Last updated
11 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Cortes J, Hurvitz SA, O'Shaughnessy J, Delaloge S, Iwata H, Rugo HS, Neven P, Kanagavel D, Cohen P, Paux G, Cartot-Cotton S, Stefanova-Urena M, Deyme L, Aouni J, Sebastien B, Bardia A. Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Primary Results From AMEERA-5. J Clin Oncol. 2024 Aug 1;42(22):2680-2690. doi: 10.1200/JCO.23.02036. Epub 2024 Jun 18.

    PubMed 38889373

  • 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.

    PubMed 35309087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SAR439859, Palbociclib and Letrozole in people with Breast Cancer, run by Sanofi at 249 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 249 sites in United States, China, Japan, Turkey (Türkiye), Argentina and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04478266, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in