NCT04059484|TerminatedPhase 2ResultsDMCFDA Drug

Study Stopped

Sponsor decision to prematurely stop the study, not linked to any safety concern.

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

AMEERA-3

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

Sanofi ClinicalTrials.gov

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3 other identifiers

ACT16105U1111-1217-27742018-004593-98

Study Type

interventional

Target

367

Locations

23 countries

Sites

109

Timeline

RegisteredAug 2019

StartedOct 2019

CompletionJan 2025

Brief Summary

Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives:

To compare the overall survival in the 2 treatment arms
To assess the objective response rate in the 2 treatment arms
To evaluate the disease control rate in the 2 treatment arms
To evaluate the clinical benefit rate in the 2 treatment arms
To evaluate the duration of response in the 2 treatment arms
To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms
To evaluate the pharmacokinetics of amcenestrant as single agent
To evaluate health-related quality of life in the 2 treatment arms
To compare the overall safety profile in the 2 treatment arms

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

367

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2019

Longer than P75 for phase_2

Geographic Reach

23 countries

109 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.2 years study duration

First Submitted

Initial submission to the registry

August 9, 2019

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

October 22, 2019

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 30, 2023

Completed

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

August 9, 2019

Results QC Date

February 14, 2023

Last Update Submit

February 5, 2026

Conditions

Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

Progression Free Survival (PFS)
PFS is defined as the time in months interval 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 independent central review (ICR) 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: 116 weeks)
Chinese Cohort: Progression Free Survival
PFS is defined as the time in months interval from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by ICR 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. 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, up to primary completion date of 15-Feb-2022, a maximum of 121 weeks

Secondary Outcomes (25)

Overall Survival (OS)
From randomization to the death due to any cause or data cut-off date whichever comes first (maximum duration: 116 weeks)
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: 116 weeks)
Percentage of Participants With Disease Control
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)
Percentage of Participants With Clinical Benefit
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)
Duration of Response (DOR)
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)
+20 more secondary outcomes

Study Arms (2)

Amcenestrant

EXPERIMENTAL

Daily amcenestrant dose administered orally under fed or fast condition

Drug: Amcenestrant

Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator

ACTIVE COMPARATOR

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)

Drug: FulvestrantDrug: AnastrozoleDrug: LetrozoleDrug: ExemestaneDrug: Tamoxifen

Interventions

AmcenestrantDRUG

Pharmaceutical form: Capsule Route of administration: Oral

Amcenestrant

FulvestrantDRUG

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Also known as: Faslodex®