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

NCT04478266 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: EFC159352020-001824-33U1111-1233-0486
• Study Type: interventional
• Target: 1,068
• Locations: 29 countries
• Sites: 244

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (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.

  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)

• Overall Survival (OS)

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

• 12-month Progression-free Survival (PFS) Rate

  Month 12

• Percentage of Participants With Objective Response

  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)

• Duration of Response (DOR)

  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)

• Percentage of Participants With Clinical Benefit

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

Study Arms (2)

Letrozole + Palbociclib

ACTIVE COMPARATOR

Participants 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.

Drug: Amcenestrant-matching placebo; Drug: Palbociclib; Drug: Letrozole; Drug: Goserelin

Amcenestrant + Palbociclib

EXPERIMENTAL

Participants 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.

Drug: SAR439859; Drug: Palbociclib; Drug: Goserelin; Drug: Letrozole-matching placebo

Interventions

Amcenestrant-matching placebo DRUG

Pharmaceutical form: Tablets Route of Administration: Oral

Letrozole + Palbociclib

SAR439859 DRUG

Pharmaceutical form: Tablets Route of Administration: Oral

Also known as: Amcenestrant

Amcenestrant + Palbociclib

Palbociclib DRUG

Pharmaceutical form: Capsules/Tablets Route of Administration: Oral

Also known as: Ibrance

Amcenestrant + Palbociclib; Letrozole + Palbociclib

Letrozole DRUG

Pharmaceutical form: Capsules Route of Administration: Orally

Letrozole + Palbociclib

Goserelin DRUG

Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

Amcenestrant + Palbociclib; Letrozole + Palbociclib

Letrozole-matching placebo DRUG

Pharmaceutical form: Capsules Route of Administration: Orally

Amcenestrant + Palbociclib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (249)

Investigational Site Number :8400075

Daphne, Alabama, 36526, United States

Location

Investigational Site Number :8400083

Glendale, Arizona, 85308, United States

Location

Investigational Site Number :8400066

Tucson, Arizona, 85712, United States

Location

Investigational Site Number :8400038

Fullerton, California, 92835, United States

Location

Investigational Site Number :8400056

Los Alamitos, California, 90720, United States

Location

Investigational Site Number :8400029

Santa Monica, California, 90404, United States

Location

Investigational Site Number :8400025

Denver, Colorado, 80262, United States

Location

Investigational Site Number :8400059

Lakeland, Florida, 33805, United States

Location

Investigational Site Number :8400053

Orlando, Florida, 32804, United States

Location

Investigational Site Number :8400081

Palm Bay, Florida, 32901, United States

Location

Investigational Site Number :8400055

Athens, Georgia, 30607, United States

Location

Investigational Site Number :8400016

Atlanta, Georgia, 30342, United States

Location

Investigational Site Number :8400034

Savannah, Georgia, 31405, United States

Location

Investigational Site Number :8400035

Thomasville, Georgia, 31792, United States

Location

Investigational Site Number :8400039

Chicago, Illinois, 60612, United States

Location

Investigational Site Number :8400008

Fort Wayne, Indiana, 46804, United States

Location

Investigational Site Number :8400006

Iowa City, Iowa, 52242, United States

Location

Investigational Site Number :8400013

Westwood, Kansas, 66205-2003, United States

Location

Investigational Site Number :8400028

Scarborough, Maine, 04074-9308, United States

Location

Investigational Site Number :8400017

Boston, Massachusetts, 02114, United States

Location

Investigational Site Number :8400076

Danvers, Massachusetts, 01923, United States

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Investigational Site Number :8400077

Newton, Massachusetts, 02463, United States

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Investigational Site Number :8400002

Ann Arbor, Michigan, 48109, United States

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Investigational Site Number :8400005

Kansas City, Missouri, 64111, United States

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Investigational Site Number :8400004

St Louis, Missouri, 63141, United States

Location

Investigational Site Number :8400058

Las Vegas, Nevada, 89102, United States

Location

Investigational Site Number :8400015

New Brunswick, New Jersey, 08901-1914, United States

Location

Investigational Site Number :8400024

Paramus, New Jersey, 00000, United States

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Investigational Site Number :8400010

New York, New York, 10016, United States

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Investigational Site Number :8400023

Stony Brook, New York, 11794-8121, United States

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Investigational Site Number :8400009

Winston-Salem, North Carolina, 27157, United States

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Investigational Site Number :8400067

Tigard, Oregon, 97223, United States

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Investigational Site Number :8400001

Pittsburgh, Pennsylvania, 15232, United States

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Investigational Site Number :8400073

Austin, Texas, 78745, United States

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Investigational Site Number :8400072

Dallas, Texas, 75231, United States

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Investigational Site Number :8400070

Dallas, Texas, 75246, United States

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Investigational Site Number :8400080

Denton, Texas, 76021, United States

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Investigational Site Number :8400061

Houston, Texas, 77024, United States

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Investigational Site Number :8400068

Houston, Texas, 77024, United States

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Investigational Site Number :8400084

Plano, Texas, 75093, United States

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Investigational Site Number :8400086

The Woodlands, Texas, 77380, United States

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Investigational Site Number :8400078

Waco, Texas, 76712, United States

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Investigational Site Number :8400082

Webster, Texas, 77598, United States

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Investigational Site Number :8400085

Blacksburg, Virginia, 24060, United States

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Investigational Site Number :8400069

Winchester, Virginia, 22601, United States

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Investigational Site Number :0320001

CABA, Buenos Aires, C1012AAR, Argentina

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Investigational Site Number :0320005

CABA, Buenos Aires, C1019ABS, Argentina

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Investigational Site Number :0320008

Capital Federal, Buenos Aires, C1417DTB, Argentina

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Pergamino, Buenos Aires, B2700CPM, Argentina

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Investigational Site Number :0320010

Córdoba, Córdoba Province, 5000, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Investigational Site Number :0320004

Buenos Aires, C1125ABD, Argentina

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Investigational Site Number :0320003

La Rioja, 5300, Argentina

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Investigational Site Number :0320009

Mar del Plata, B7600FYK, Argentina

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Investigational Site Number :0320007

Salta, 4400, Argentina

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Investigational Site Number :0360004

Macquarie Park, New South Wales, 2109, Australia

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Investigational Site Number :0360005

Randwick, New South Wales, 2031, Australia

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Investigational Site Number :0360003

Wahroonga, New South Wales, 2076, Australia

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Investigational Site Number :0360002

Richmond, Victoria, 3121, Australia

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Investigational Site Number :0360001

Nedlands, Western Australia, 6009, Australia

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Investigational Site Number :0400001

Graz, 8036, Austria

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Investigational Site Number :0560003

Brussels, BE-1200, Belgium

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Investigational Site Number :0560004

Charleroi, B-6000, Belgium

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Investigational Site Number :0560001

Leuven, 3000, Belgium

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Investigational Site Number :0560002

Namur, 5000, Belgium

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Investigational Site Number :0760005

Porto Alegre, Rio Grande do Sul, 90035 003, Brazil

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Investigational Site Number :0760006

Porto Alegre, Rio Grande do Sul, 91350-250, Brazil

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Investigational Site Number :0760007

São Paulo, São Paulo, 01509-900, Brazil

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Investigational Site Number :0760003

São Paulo, São Paulo, 04014-002, Brazil

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Investigational Site Number :0760004

Rio de Janeiro, 20230-130, Brazil

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Investigational Site Number :0760008

São Paulo, 04321-120, Brazil

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Investigational Site Number :1000004

Burgas, 8000, Bulgaria

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Investigational Site Number :1000005

Dobrich, Bulgaria

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Investigational Site Number :1000008

Rousse, 7002, Bulgaria

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Investigational Site Number :1000001

Sofia, 1797, Bulgaria

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Investigational Site Number :1240004

Kingston, Ontario, K7L 2V7, Canada

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Investigational Site Number :1240002

Toronto, Ontario, M4N 3M5, Canada

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Investigational Site Number :1240007

Greenfield Park, Quebec, J4V 2H1, Canada

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Investigational Site Number :1240014

Montreal, Quebec, H3T 1S6, Canada

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Investigational Site Number :1240005

Montreal, Quebec, H4A 3J1, Canada

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Investigational Site Number :1520005

La Serena, Coquimbo Region, 1720430, Chile

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Investigational Site Number :1520004

Temuco, La Araucanía, 4810561, Chile

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Investigational Site Number :1520009

Talca, Maule Region, Chile

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Investigational Site Number :1520011

Santaigo, Reg Metropolitana de Santiago, 8241470, Chile

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Investigational Site Number :1520006

Santiago, Reg Metropolitana de Santiago, 7650568, Chile

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Investigational Site Number :1520002

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

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Investigational Site Number :1520001

Viña del Mar, Región de Valparaíso, 2520598, Chile

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Investigational Site Number :1520007

Santiago, 7500921, Chile

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Investigational Site Number :1520003

Santiago, Chile

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Investigational Site Number :1560038

Baoding, 071000, China

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Investigational Site Number :1560008

Beijing, 100142, China

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Investigational Site Number :1560035

Beijing, 100730, China

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Investigational Site Number :1560003

Changchun, 130021, China

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Investigational Site Number :1560036

Changchun, 130041, China

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Investigational Site Number :1560013

Chengdu, 610041, China

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Investigational Site Number :1560019

Chongqing, 400030, China

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Investigational Site Number :1560031

Dalian, 116011, China

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Investigational Site Number :1560021

Dalian, 116027, China

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Investigational Site Number :1560054

Deyang, 618000, China

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Investigational Site Number :1560043

Fuzhou, 354200, China

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Investigational Site Number :1560025

Guangzhou, 510080, China

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Investigational Site Number :1560006

Hangzhou, 310003, China

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Investigational Site Number :1560007

Hangzhou, 310009, China

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Investigational Site Number :1560002

Hangzhou, 310016, China

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Investigational Site Number :1560005

Hangzhou, 310022, China

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Investigational Site Number :1560011

Harbin, 150081, China

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Investigational Site Number :1560041

Hefei, 233004, China

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Investigational Site Number :1560018

Jinan, 250013, China

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Investigational Site Number :1560046

Jinan, 250117, China

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Investigational Site Number :1560051

Jining, China

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Investigational Site Number :1560017

Linyi, 276000, China

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Investigational Site Number :1560055

Luoyang, 471003, China

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Investigational Site Number :1560048

Neijiang, 641003, China

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Investigational Site Number :1560001

Shanghai, 200032, China

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Investigational Site Number :1560037

Shaoguan, 512025, China

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Investigational Site Number :1560028

Tianjin, 300060, China

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Investigational Site Number :1560033

Wuhan, 430060, China

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Investigational Site Number :1560024

Wuhan, 430079, China

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Investigational Site Number :1560045

Xi'an, 710004, China

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Investigational Site Number :1560044

Xi'an, 710061, China

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Investigational Site Number :1560027

Xuzhou, 221009, China

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Investigational Site Number :1560049

Yantai, 264000, China

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Investigational Site Number :1560022

Zhengzhou, 450008, China

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Investigational Site Number :2030001

Brno, 65653, Czechia

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Investigational Site Number :2030002

Prague, 12808, Czechia

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Investigational Site Number :2460001

Helsinki, 00029, Finland

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Investigational Site Number :2460002

Tampere, 33520, Finland

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Investigational Site Number :2460003

Turku, FIN-20520, Finland

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Investigational Site Number :2500009

Nice, 06189, France

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Investigational Site Number :2500003

Paris, 75010, France

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Investigational Site Number :2500001

Paris, 75248, France

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Investigational Site Number :2500006

Poitiers, 86021, France

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Investigational Site Number :2500007

Saint-Cloud, 92210, France

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Investigational Site Number :2500002

Saint-Herblain, 44805, France

Location

Investigational Site Number :2500010

Strasbourg, 67033, France

Location

Investigational Site Number :2500005

Toulouse, 31059, France

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Investigational Site Number :2500004

Villejuif, 94800, France

Location

Investigational Site Number :2680005

Batumi, 6000, Georgia

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Investigational Site Number :2680006

Kutaisi, 4600, Georgia

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Investigational Site Number :2680001

Tbilisi, 0112, Georgia

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Investigational Site Number :2680002

Tbilisi, 0144, Georgia

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Investigational Site Number :2680004

Tbilisi, 0159, Georgia

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Investigational Site Number :2680007

Tbilisi, 0159, Georgia

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Investigational Site Number :2680003

Tbilisi, 0168, Georgia

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Investigational Site Number :2760006

Bottrop, 46236, Germany

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Investigational Site Number :2760003

Münster, 48149, Germany

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Investigational Site Number :2760007

Oldenburg in Holstein, 23758, Germany

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Investigational Site Number :2760001

Ulm, 89075, Germany

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Investigational Site Number :3480008

Budapest, 1115, Hungary

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Investigational Site Number :3480005

Győr, 9023, Hungary

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Investigational Site Number :3480011

Gyula, 5700, Hungary

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Investigational Site Number :3480003

Kaposvár, 7400, Hungary

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Investigational Site Number :3480009

Kecskemét, 6000, Hungary

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Investigational Site Number :3480010

Miskolc, 3526, Hungary

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Investigational Site Number :3480001

Nyíregyháza, 4400, Hungary

Location

Investigational Site Number :3800008

Meldola (FC), Emilia-Romagna, 47014, Italy

Location

Investigational Site Number :3800003

Rozzano, Milano, 20089, Italy

Location

Investigational Site Number :3800007

Monza, Monza E Brianza, 20052, Italy

Location

Investigational Site Number :3800010

Bologna, 40138, Italy

Location

Investigational Site Number :3800004

Milan, 20132, Italy

Location

Investigational Site Number :3800002

Milan, 20141, Italy

Location

Investigational Site Number :3800006

Napoli, 80131, Italy

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Investigational Site Number :3800005

Prato, 59100, Italy

Location

Investigational Site Number :3920016

Nagoya, Aichi-ken, 460-0001, Japan

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Investigational Site Number :3920007

Nagoya, Aichi-ken, 464-8681, Japan

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Investigational Site Number :3920002

Kashiwa-shi, Chiba, 277-8577, Japan

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Investigational Site Number :3920009

Matsuyama, Ehime, 791-0280, Japan

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Investigational Site Number :3920019

Kurume-shi, Fukuoka, 830-0013, Japan

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Investigational Site Number :3920017

Takasaki-shi, Gunma, 370-0829, Japan

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Investigational Site Number :3920010

Hiroshima, Hiroshima, 730-8518, Japan

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Investigational Site Number :3920001

Sapporo, Hokkaido, 003-0804, Japan

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Investigational Site Number :3920012

Kagoshima, Kagoshima-ken, 892-0833, Japan

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Investigational Site Number :3920014

Yokohama, Kanagawa, 222-0036, Japan

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Investigational Site Number :3920006

Yokohama, Kanagawa, 241-8515, Japan

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Investigational Site Number :3920020

Sendai, Miyagi, 980-0803, Japan

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Investigational Site Number :3920022

Miyazaki, Miyazaki, 880-8510, Japan

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Investigational Site Number :3920008

Osaka, Osaka, 540-0006, Japan

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Investigational Site Number :3920018

Osaka, Osaka, 553-0003, Japan

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Investigational Site Number :3920013

Hidaka-shi, Saitama, 350-1241, Japan

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Investigational Site Number :3920021

Shizuoka, Shizuoka, 420-8527, Japan

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Investigational Site Number :3920003

Koto-ku, Tokyo, 135-8550, Japan

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Investigational Site Number :3920015

Meguro-ku, Tokyo, 152-8902, Japan

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Investigational Site Number :3920005

Shinagawa-ku, Tokyo, 142-8666, Japan

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Investigational Site Number :5280006

Arnhem, 6815 AD, Netherlands

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Investigational Site Number :5280005

Delft, 2625 AD, Netherlands

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Investigational Site Number :5280001

Maastricht, 6229 HX, Netherlands

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Investigational Site Number :6160007

Poznan, Greater Poland Voivodeship, 61-866, Poland

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Investigational Site Number :6160002

Tomaszów Mazowiecki, Lódzkie, 97-200, Poland

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Investigational Site Number :6200005

Almada, 2801-951, Portugal

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Investigational Site Number :6200001

Lisbon, 1649-035, Portugal

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Investigational Site Number :6200002

Porto, 4200-319, Portugal

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Investigational Site Number :6430007

Arkhangelsk, 163045, Russia

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Investigational Site Number :6430004

Krasnogorskiy District, 143423, Russia

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Investigational Site Number :6430008

Moscow, 115478, Russia

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Investigational Site Number :6430003

Moscow, 117186, Russia

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Investigational Site Number :6430005

Moscow, 117997, Russia

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Investigational Site Number :6430006

Moscow, 129090, Russia

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Investigational Site Number :6430009

Moscow Region, 143442, Russia

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Investigational Site Number :6430001

Saint Petersburg, 197758, Russia

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Investigational Site Number :6430010

Saint Petersburg, 199034, Russia

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Investigational Site Number :7020002

Singapore, 119228, Singapore

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Investigational Site Number :7020004

Singapore, 169610, Singapore

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Investigational Site Number :7020001

Singapore, 329563, Singapore

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Investigational Site Number :7100004

Cape Town, 7570, South Africa

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Investigational Site Number :7100006

Johannesburg, 1709, South Africa

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Investigational Site Number :4100006

Goyang-si, Gyeonggi-do, 10408, South Korea

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Investigational Site Number :4100005

Seongnam-si, Gyeonggi-do, 463-707, South Korea

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Investigational Site Number :4100007

Seoul, Seoul-teukbyeolsi, 02841, South Korea

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Investigational Site Number :4100004

Seoul, Seoul-teukbyeolsi, 03722, South Korea

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Investigational Site Number :4100003

Seoul, Seoul-teukbyeolsi, 110-744, South Korea

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Investigational Site Number :4100002

Seoul, Seoul-teukbyeolsi, 135-710, South Korea

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Investigational Site Number :4100001

Seoul, Seoul-teukbyeolsi, 138-878, South Korea

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Investigational Site Number :4100009

Seochogu, 6591, South Korea

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Investigational Site Number :4100008

Seongnam-si, Gyeonggi-do, 13496, South Korea

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Investigational Site Number :7240011

Barcelona, Barcelona [Barcelona], 08017, Spain

Location

Investigational Site Number :7240008

Barcelona / Sabadell, Castille and León, 08208, Spain

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Investigational Site Number :7240003

Santiago de Compostela, Galicia [Galicia], 15706, Spain

Location

Investigational Site Number :7240004

Madrid, Madrid, Comunidad de, 28046, Spain

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Investigational Site Number :7240006

Madrid / Madrid, Madrid, Comunidad de, 28007, Spain

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Investigational Site Number :7240002

Madrid / Madrid, Madrid, Comunidad de, 28050, Spain

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Investigational Site Number :7240005

Valencia, Valenciana, Comunidad, 46010, Spain

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Investigational Site Number :7240001

Madrid, 28041, Spain

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Investigational Site Number :7240007

Málaga, 29010, Spain

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Investigational Site Number :7240009

Valencia, 46015, Spain

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Investigational Site Number :1580007

Kaohsiung City, 807, Taiwan

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Investigational Site Number :1580002

Tainan, Taiwan

Location

Investigational Site Number :1580001

Taipei, 100, Taiwan

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Investigational Site Number :1580003

Taipei, 10449, Taiwan

Location

Investigational Site Number :7920006

Adana, 01120, Turkey (Türkiye)

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Investigational Site Number :7920008

Ankara, 06100, Turkey (Türkiye)

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Investigational Site Number :7920009

Ankara, 06200, Turkey (Türkiye)

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Investigational Site Number :7920007

Antalya, 07070, Turkey (Türkiye)

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Investigational Site Number :7920005

Bornova, 35100, Turkey (Türkiye)

Location

Investigational Site Number :7920013

Diyarbakır, 21100, Turkey (Türkiye)

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Investigational Site Number :7920003

Edirne, 22030, Turkey (Türkiye)

Location

Investigational Site Number :7920001

Istanbul, 34214, Turkey (Türkiye)

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Investigational Site Number :7920011

Istanbul, 34457, Turkey (Türkiye)

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Investigational Site Number :7920004

Istanbul, 34722, Turkey (Türkiye)

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Investigational Site Number :7920012

Izmir, 0000, Turkey (Türkiye)

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Investigational Site Number :7920010

Kocaeli, 41380, Turkey (Türkiye)

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Investigational Site Number :7920002

Malatya, 44280, Turkey (Türkiye)

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Investigational Site Number :8040004

Kharkiv, 61103, Ukraine

Location

Investigational Site Number :8040010

Kharkiv, 61166, Ukraine

Location

Investigational Site Number :8040001

Kryvyi Rih, 50048, Ukraine

Location

Investigational Site Number :8040002

Odesa, 65025, Ukraine

Location

Investigational Site Number :8040007

Vinnytsia, 21029, Ukraine

Location

Investigational Site Number :8260001

Glasgow, Central Bedfordshire, G12 0YN, United Kingdom

Location

Investigational Site Number :8260002

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

Location

Investigational Site Number :8260005

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38889373 DERIVED

• 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.

  PMID: 35309087 DERIVED

Related Links

• EFC15935 Plain Language Results Summary

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Letrozole; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 20, 2020
• Study Start: October 14, 2020
• Primary Completion: June 28, 2022
• Study Completion: May 26, 2023
• Last Updated: September 11, 2025
• Results First Posted: July 6, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); BU (4); FI (3); JP (20); CA (5); CZ (2); SG (3); ES (10); KR (9); ZA (2); CN (34); US (45); IT (8); TW (4); TU (13); CL (9); BE (4); GE (7); PT (3); GB (3); DE (4); FR (9); UA (5); HU (7); PL (2); NL (3); AR (10); BR (6); RU (9)