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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04059484




Registration number
NCT04059484
Ethics application status
Date submitted
9/08/2019
Date registered
16/08/2019

Titles & IDs
Public title
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
Scientific title
An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies
Secondary ID [1] 0 0
U1111-1217-2774
Secondary ID [2] 0 0
ACT16105
Universal Trial Number (UTN)
Trial acronym
AMEERA-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer Metastatic 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
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane
Treatment: Drugs - Tamoxifen

Experimental: Amcenestrant - Daily amcenestrant dose administered orally under fed or fast condition

Active comparator: Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator - Control treatment of the choice of the physician depending on each participant's medical condition and in accordance with the approved label may include 1 of the following treatments used as monotherapy.

Fulvestrant

Aromatase inhibitors (anastrozole, letrozole, exemestane)

Selective estrogen receptor modulator (Tamoxifen)


Treatment: Drugs: Amcenestrant
Pharmaceutical form: Capsule

Route of administration: Oral

Treatment: Drugs: Fulvestrant
Pharmaceutical form: Solution for injection

Route of administration: Intramuscular

Treatment: Drugs: Anastrozole
Pharmaceutical form:Tablets or capsules

Route of administration: Oral

Treatment: Drugs: Letrozole
Pharmaceutical form: Tablets or capsules

Route of administration: Oral

Treatment: Drugs: Exemestane
Pharmaceutical form: Tablets or capsules

Route of administration: Oral

Treatment: Drugs: Tamoxifen
Pharmaceutical form: Tablets or capsules

Route of administration: Oral
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: 116 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: 116 weeks)
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response
Timepoint [2] 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: 116 weeks)
Secondary outcome [3] 0 0
Percentage of Participants With Disease Control
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: 116 weeks)
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Benefit
Timepoint [4] 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: 116 weeks)
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
From the date of first response to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 116 weeks)
Secondary outcome [6] 0 0
Progression Free Survival (PFS) According to Estrogen Receptor 1 Gene (ESR1) Mutation Status
Timepoint [6] 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: 116 weeks)
Secondary outcome [7] 0 0
Pharmacokinetics: Plasma Concentrations of Amcenestrant
Timepoint [7] 0 0
Cycle 1 Day 1: 1.5 hours(h), 4h post-dose, Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 1.5h, 4h, 8h post-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 6 Day 1: pre-dose
Secondary outcome [8] 0 0
Within-Participant Steady State Ctrough of Amcenestrant
Timepoint [8] 0 0
Predose on Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 6 Day 1
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 30 [i.e.,116 weeks])
Secondary outcome [10] 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 [10] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 30 [i.e.,116 weeks])
Secondary outcome [11] 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
Timepoint [11] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 30 [i.e.,116 weeks])
Secondary outcome [12] 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 [12] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 30 [i.e.,116 weeks])

Eligibility
Key inclusion criteria
Inclusion criteria :

* 18 years or older.
* Histological or cytological diagnosis of adenocarcinoma of the breast.
* Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
* Estrogen receptor(ER) positive status.
* Human epidermal growth factor receptor 2 negative status.
* Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
* In the main study, a prior treatment with a Cyclin-dependent kinase 4 and 6(CDK 4/6) inhibitor is mandatory if this treatment is approved and can be reimbursed for this participant. The percentage of participants without previous CDK 4/6 inhibitor will be capped to 20%. In the Chinese extension cohort, previous treatment with a CDK 4/6 inhibitor will not be mandatory, and there will be no limitation to the number of participants naïve to CDK4/6 inhibitor.
* Participants must present a secondary endocrine resistance to endocrine therapy defined as: progression while on endocrine therapy after at least 6 months of treatment for advanced breast cancer, or relapse while on adjuvant endocrine therapy but after the first 2 years, or with a relapse within 12 months after completing adjuvant endocrine therapy.
* Male or Female.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Eastern Cooperative Oncology Group performance status =>2.
* Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant. Participants unable to swallow normally and to take capsules.
* Participant with any other cancer. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for greater than 3 years are allowed.
* Severe uncontrolled systemic disease at screening .
* Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms.
* Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader(SERD) compound, except fulvestrant if stopped for at least 3 months before randomization.
* Treatment with drugs that have the potential to inhibit Uridine'5 Diphospho-Glucuronosyl Transferase(UGT) less than 2 weeks before randomization.
* Treatment with strong Cytochrome P450 (CYP)3A inducers within 2 weeks before randomization.
* Ongoing treatment with drugs that are sensitive substrate of organic anion transporting polypeptide 1B1/B3(OATP1B1/B3) (asunaprevir, atorvastatin, bosentan, danoprevir, fexofenadine, glyburide, nateglinide, pitavastatin, pravastatin, replaglinide, rosuvastatin, and simvastatin acid).
* Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
* Inadequate hematological, coagulation, renal and liver functions.

The above information is not intended to contain all considerations relevant to a patient'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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
Accrual to date
Final
367
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - South Brisbane
Recruitment hospital [2] 0 0
Investigational Site Number : 0360002 - Woolloongabba
Recruitment hospital [3] 0 0
Investigational Site Number : 0360001 - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Vermont
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
La Rioja
Country [17] 0 0
Argentina
State/province [17] 0 0
Salta
Country [18] 0 0
Belgium
State/province [18] 0 0
Charleroi
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Belgium
State/province [20] 0 0
Namur
Country [21] 0 0
Brazil
State/province [21] 0 0
Goiás
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio Grande Do Sul
Country [23] 0 0
Brazil
State/province [23] 0 0
São Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
China
State/province [27] 0 0
Beijing
Country [28] 0 0
China
State/province [28] 0 0
Changchun
Country [29] 0 0
China
State/province [29] 0 0
Changsha
Country [30] 0 0
China
State/province [30] 0 0
Chengdu
Country [31] 0 0
China
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Chongqing
Country [32] 0 0
China
State/province [32] 0 0
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
Country [36] 0 0
China
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Kunming
Country [37] 0 0
China
State/province [37] 0 0
Linyi
Country [38] 0 0
China
State/province [38] 0 0
Nanjing
Country [39] 0 0
China
State/province [39] 0 0
Tianjin
Country [40] 0 0
China
State/province [40] 0 0
Urumqi
Country [41] 0 0
China
State/province [41] 0 0
Wuhan
Country [42] 0 0
China
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Xuzhou
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Czechia
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Brno
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Czechia
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Novy Jicin
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Czechia
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Praha 4
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France
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ANGERS Cedex 02
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France
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Creteil
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France
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Marseille
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France
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Paris
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France
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Villejuif
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Greece
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Heraklion
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Greece
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Larisa
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Greece
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Thessaloniki
Country [54] 0 0
Israel
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Jerusalem
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Israel
State/province [55] 0 0
Petah-Tikva
Country [56] 0 0
Israel
State/province [56] 0 0
Tel Aviv
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Israel
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Tel HaShomer
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Italy
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Torino
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Italy
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Milano
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Italy
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Prato
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Japan
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Aichi
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Japan
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Chiba
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Gunma
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Japan
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Kanagawa
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Korea, Republic of
State/province [68] 0 0
Seoul-teukbyeolsi
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Latvia
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Riga
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Mexico
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Nuevo León
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Mexico
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Mexico
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Mexico
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Veracruz
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Poland
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Mazowieckie
Country [74] 0 0
Poland
State/province [74] 0 0
Wielkopolskie
Country [75] 0 0
Puerto Rico
State/province [75] 0 0
Ponce De Leon 735 Hato Rey
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Saint -Petersburg
Country [78] 0 0
Spain
State/province [78] 0 0
Barcelona [Barcelona]
Country [79] 0 0
Spain
State/province [79] 0 0
Catalunya [Cataluña]
Country [80] 0 0
Spain
State/province [80] 0 0
Málaga
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taichung
Country [82] 0 0
Taiwan
State/province [82] 0 0
Tainan
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Turkey
State/province [84] 0 0
Ankara
Country [85] 0 0
Turkey
State/province [85] 0 0
Edirne
Country [86] 0 0
Turkey
State/province [86] 0 0
Istanbul
Country [87] 0 0
Ukraine
State/province [87] 0 0
Kryvyi Rih
Country [88] 0 0
Ukraine
State/province [88] 0 0
Odesa
Country [89] 0 0
Ukraine
State/province [89] 0 0
Uzhgorod

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

TypeCitations or Other Details
Journal Tolaney SM, Chan A, Petrakova K, Delaloge S, Campo... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04059484