Amcenestrant for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast Cancer+1 More
Amcenestrant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, amcenestrant, to see if it is better than the current standard of care for treating metastatic or locally advanced breast cancer. The secondary objectives are to compare overall survival, objective response rate, disease control rate, clinical benefit rate, duration of response, and safety profile between the two treatment arms. The trial will also assess the pharmacokinetics of amcenestrant and evaluate health-related quality of life in both treatment groups.

Eligible Conditions
  • Breast Cancer
  • Breast

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Evaluated continuously throughout study from the date of enrollment, up to 30 days after last study treatment administration

Day 28
Assessments of the pharmacokinetic (PK) parameter of amcenestrant as single agent: plasma concentrations
Day 30
Breast
Patient Reported Outcome (PRO) - health-related quality of life and health status using the European Quality of Life-5 Dimensions (EQ-5D)
Patient Reported Outcome (PRO) - the European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC-QLQ-C30)
Day 30
Overall safety profile - Treatment-Emergent Adverse events
Month 18
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
PFS according to (ESR1) mutation status
Progression free survival (PFS)
Month 64
Overall Survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator
1 of 2
Amcenestrant
1 of 2
Active Control
Experimental Treatment

367 Total Participants · 2 Treatment Groups

Primary Treatment: Amcenestrant · No Placebo Group · Phase 2

Amcenestrant
Drug
Experimental Group · 1 Intervention: Amcenestrant · Intervention Types: Drug
Fulvestrant/Aromatase inhibitors/Estrogen receptor modulatorActiveComparator Group · 5 Interventions: Anastrozole, Exemestane, Tamoxifen, Fulvestrant, Letrozole · Intervention Types: Drug, Drug, Drug, Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: evaluated continuously throughout study from the date of enrollment, up to 30 days after last study treatment administration

Who is running the clinical trial?

SanofiLead Sponsor
2,029 Previous Clinical Trials
2,908,002 Total Patients Enrolled
52 Trials studying Breast Cancer
23,720 Patients Enrolled for Breast Cancer
Clinical Sciences & OperationsStudy DirectorSanofi
787 Previous Clinical Trials
1,582,704 Total Patients Enrolled
11 Trials studying Breast Cancer
2,117 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
You have a histological or cytological diagnosis of breast cancer.
You have HER2 negative breast cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.