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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04478266




Registration number
NCT04478266
Ethics application status
Date submitted
10/07/2020
Date registered
20/07/2020

Titles & IDs
Public title
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Scientific 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
Secondary ID [1] 0 0
2020-001824-33
Secondary ID [2] 0 0
EFC15935
Universal Trial Number (UTN)
Trial acronym
AMEERA-5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amcenestrant-matching placebo
Treatment: Drugs - SAR439859
Treatment: Drugs - Palbociclib
Treatment: Drugs - Letrozole
Treatment: Drugs - Goserelin
Treatment: Drugs - Letrozole-matching placebo

Active comparator: Letrozole + Palbociclib - 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.

Experimental: Amcenestrant + Palbociclib - 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.


Treatment: Drugs: Amcenestrant-matching placebo
Pharmaceutical form: Tablets Route of Administration: Oral

Treatment: Drugs: SAR439859
Pharmaceutical form: Tablets Route of Administration: Oral

Treatment: Drugs: Palbociclib
Pharmaceutical form: Capsules/Tablets Route of Administration: Oral

Treatment: Drugs: Letrozole
Pharmaceutical form: Capsules Route of Administration: Orally

Treatment: Drugs: Goserelin
Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

Treatment: Drugs: Letrozole-matching placebo
Pharmaceutical form: Capsules Route of Administration: Orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
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 outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks)
Secondary outcome [2] 0 0
12-month Progression-free Survival (PFS) Rate
Timepoint [2] 0 0
Month 12
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Percentage of Participants With Clinical Benefit
Timepoint [5] 0 0
From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks)
Secondary outcome [6] 0 0
Progression-free Survival on Next Line of Therapy (PFS2)
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Pharmacokinetics: Plasma Concentrations of Amcenestrant
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Pharmacokinetics: Plasma Concentrations of Palbociclib
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores
Timepoint [9] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [10] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores
Timepoint [10] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [11] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores
Timepoint [11] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [14] 0 0
Time to First Chemotherapy
Timepoint [14] 0 0
From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks)
Secondary outcome [15] 0 0
Number of Participants With Hematological Abnormalities During the Treatment Period
Timepoint [15] 0 0
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)
Secondary outcome [16] 0 0
Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period
Timepoint [16] 0 0
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/05/2023
Sample size
Target
Accrual to date
Final
1068
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number :0360004 - Macquarie Park
Recruitment hospital [2] 0 0
Investigational Site Number :0360005 - Randwick
Recruitment hospital [3] 0 0
Investigational Site Number :0360003 - Wahroonga
Recruitment hospital [4] 0 0
Investigational Site Number :0360002 - Richmond
Recruitment hospital [5] 0 0
Investigational Site Number :0360001 - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
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New York
Country [18] 0 0
United States of America
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North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Córdoba
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Argentina
State/province [26] 0 0
La Rioja
Country [27] 0 0
Argentina
State/province [27] 0 0
Mar del Plata
Country [28] 0 0
Argentina
State/province [28] 0 0
Salta
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Belgium
State/province [30] 0 0
Bruxelles
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Belgium
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Charleroi
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Belgium
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Leuven
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Belgium
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Namur
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Rio De Janeiro
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Bulgaria
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Burgas
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Bulgaria
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Dobrich
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Bulgaria
State/province [39] 0 0
Russe
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
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Canada
State/province [41] 0 0
Ontario
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Canada
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Quebec
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Chile
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Coquimbo
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Chile
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La Araucanía
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Chile
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Maule
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Chile
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Reg Metropolitana De Santiago
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Chile
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Valparaíso
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Chile
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Santiago de Chile
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Chile
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Santiago
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China
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Baoding
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China
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Beijing
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China
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Changchun
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China
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Chengdu
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China
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Chongqing
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China
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Dalian
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China
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Deyang
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China
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Fuzhou
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China
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Guangzhou
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China
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Hangzhou
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China
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Harbin
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China
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Hefei
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China
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Jinan
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China
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Jining
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China
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Linyi
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China
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Luoyang
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China
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Neijiang
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China
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Shanghai
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China
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Shaoguan
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Tianjin
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China
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Wuhan
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China
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Xi'an
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China
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Xi'An
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China
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Xuzhou
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China
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Yantai
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China
State/province [75] 0 0
Zhengzhou
Country [76] 0 0
Czechia
State/province [76] 0 0
Brno
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Czechia
State/province [77] 0 0
Praha 2
Country [78] 0 0
Finland
State/province [78] 0 0
Helsinki
Country [79] 0 0
Finland
State/province [79] 0 0
Tampere
Country [80] 0 0
Finland
State/province [80] 0 0
Turku
Country [81] 0 0
France
State/province [81] 0 0
Nice
Country [82] 0 0
France
State/province [82] 0 0
Paris
Country [83] 0 0
France
State/province [83] 0 0
Poitiers
Country [84] 0 0
France
State/province [84] 0 0
Saint Cloud
Country [85] 0 0
France
State/province [85] 0 0
Saint-Herblain
Country [86] 0 0
France
State/province [86] 0 0
Strasbourg
Country [87] 0 0
France
State/province [87] 0 0
TOULOUSE Cedex 9
Country [88] 0 0
France
State/province [88] 0 0
Villejuif
Country [89] 0 0
Georgia
State/province [89] 0 0
Batumi
Country [90] 0 0
Georgia
State/province [90] 0 0
Kutaisi
Country [91] 0 0
Georgia
State/province [91] 0 0
Tbilisi
Country [92] 0 0
Germany
State/province [92] 0 0
Bottrop
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Germany
State/province [93] 0 0
Münster
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Germany
State/province [94] 0 0
Oldenburg in Holstein
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Germany
State/province [95] 0 0
Ulm
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Hungary
State/province [96] 0 0
Budapest
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Hungary
State/province [97] 0 0
Gyula
Country [98] 0 0
Hungary
State/province [98] 0 0
Gyor
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Hungary
State/province [99] 0 0
Kaposvár
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Hungary
State/province [100] 0 0
Kecskemét
Country [101] 0 0
Hungary
State/province [101] 0 0
Miskolc
Country [102] 0 0
Hungary
State/province [102] 0 0
Nyíregyháza
Country [103] 0 0
Italy
State/province [103] 0 0
Emilia-Romagna
Country [104] 0 0
Italy
State/province [104] 0 0
Milano
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Italy
State/province [105] 0 0
Monza E Brianza
Country [106] 0 0
Italy
State/province [106] 0 0
Bologna
Country [107] 0 0
Italy
State/province [107] 0 0
Napoli
Country [108] 0 0
Italy
State/province [108] 0 0
Prato
Country [109] 0 0
Japan
State/province [109] 0 0
Aichi
Country [110] 0 0
Japan
State/province [110] 0 0
Chiba
Country [111] 0 0
Japan
State/province [111] 0 0
Ehime
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Japan
State/province [112] 0 0
Fukuoka
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Japan
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Gunma
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Japan
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Hiroshima
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Japan
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Hokkaido
Country [116] 0 0
Japan
State/province [116] 0 0
Kagoshima
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Japan
State/province [117] 0 0
Kanagawa
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Japan
State/province [118] 0 0
Miyagi
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Japan
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Miyazaki
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Japan
State/province [120] 0 0
Osaka
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Japan
State/province [121] 0 0
Saitama
Country [122] 0 0
Japan
State/province [122] 0 0
Shizuoka
Country [123] 0 0
Japan
State/province [123] 0 0
Tokyo
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Korea, Republic of
State/province [124] 0 0
Gyeonggi-do
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul-teukbyeolsi
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Seochogu
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Seongnam-si, Gyeonggi-do
Country [128] 0 0
Netherlands
State/province [128] 0 0
Arnhem
Country [129] 0 0
Netherlands
State/province [129] 0 0
Delft
Country [130] 0 0
Netherlands
State/province [130] 0 0
Maastricht
Country [131] 0 0
Poland
State/province [131] 0 0
Lódzkie
Country [132] 0 0
Poland
State/province [132] 0 0
Wielkopolskie
Country [133] 0 0
Portugal
State/province [133] 0 0
Almada
Country [134] 0 0
Portugal
State/province [134] 0 0
Lisboa
Country [135] 0 0
Portugal
State/province [135] 0 0
Porto
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Arkhangelsk
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Krasnogorskiy District
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Moscow Region
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Moscow
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Saint -Petersburg
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Saint Petersburg
Country [142] 0 0
Singapore
State/province [142] 0 0
Singapore
Country [143] 0 0
South Africa
State/province [143] 0 0
Cape Town
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South Africa
State/province [144] 0 0
Johannesburg
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Spain
State/province [145] 0 0
Barcelona [Barcelona]
Country [146] 0 0
Spain
State/province [146] 0 0
Castilla Y León
Country [147] 0 0
Spain
State/province [147] 0 0
Galicia [Galicia]
Country [148] 0 0
Spain
State/province [148] 0 0
Madrid, Comunidad De
Country [149] 0 0
Spain
State/province [149] 0 0
Valenciana, Comunidad
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Spain
State/province [150] 0 0
Madrid
Country [151] 0 0
Spain
State/province [151] 0 0
Málaga
Country [152] 0 0
Spain
State/province [152] 0 0
Valencia
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Taiwan
State/province [153] 0 0
Kaohsiung
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Taiwan
State/province [154] 0 0
Tainan
Country [155] 0 0
Taiwan
State/province [155] 0 0
Taipei
Country [156] 0 0
Turkey
State/province [156] 0 0
Adana
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Turkey
State/province [157] 0 0
Ankara
Country [158] 0 0
Turkey
State/province [158] 0 0
Antalya
Country [159] 0 0
Turkey
State/province [159] 0 0
Bornova
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Turkey
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Diyarbakir
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
Country [164] 0 0
Turkey
State/province [164] 0 0
Kocaeli
Country [165] 0 0
Turkey
State/province [165] 0 0
Malatya
Country [166] 0 0
Ukraine
State/province [166] 0 0
Kharkiv
Country [167] 0 0
Ukraine
State/province [167] 0 0
Kryvyi Rih
Country [168] 0 0
Ukraine
State/province [168] 0 0
Odesa
Country [169] 0 0
Ukraine
State/province [169] 0 0
Vinnytsia
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Central Bedfordshire
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Edinburgh, City Of
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Lancashire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04478266