← Back to Search

Hormone Therapy

Amcenestrant for Breast Cancer (AMEERA-6 Trial)

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, cycle 3, 4, 5, 6, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days)
Awards & highlights

AMEERA-6 Trial Summary

This trial is studying amcenestrant to see how well it works compared to tamoxifen in treating patients with hormone receptor-positive early breast cancer who have stopped taking aromatase inhibitor therapy due to side effects.

Eligible Conditions
  • Breast Cancer

AMEERA-6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, cycle 3, 4, 5, 6, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, cycle 3, 4, 5, 6, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Breast Cancer-free Survival (IBCFS)
Secondary outcome measures
Breast Cancer-specific Survival (BCSS)
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30): Global Health Status/Quality of Life (GHQ) Scale Score
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23): Systemic Therapy Side Effects Scale Score
+6 more

AMEERA-6 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Amcenestrant with tamoxifen-matching placebo armExperimental Treatment2 Interventions
Amcenestrant dose, once daily, continuously. Tamoxifen-matching placebo, once daily, continuously.
Group II: Tamoxifen with amcenestrant-matching placeboActive Control2 Interventions
Tamoxifen dose, once daily, continuously. Amcenestrant-matching placebo, once daily, continuously.

Find a Location

Who is running the clinical trial?

Alliance Foundation Trials, LLC.OTHER
23 Previous Clinical Trials
25,029 Total Patients Enrolled
1 Trials studying Breast Cancer
5,796 Patients Enrolled for Breast Cancer
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,477 Total Patients Enrolled
51 Trials studying Breast Cancer
24,226 Patients Enrolled for Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
412 Previous Clinical Trials
165,081 Total Patients Enrolled
33 Trials studying Breast Cancer
37,702 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
2022. "Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128773.
~1 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top