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Selective Estrogen Receptor Degrader (SERD)

Amcenestrant for Advanced Breast Cancer (AMEERA-3 Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease
Estrogen receptor(ER) positive status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

AMEERA-3 Trial 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.

Who is the study for?
This trial is for adults with ER-positive, HER2-negative advanced or metastatic breast cancer who have shown resistance to endocrine therapy. They must have had no more than one prior chemotherapy or targeted therapy for advanced disease and cannot be candidates for curative surgery or radiation. Participants should not have untreated brain metastases, severe liver/renal/blood function issues, other active cancers (except certain treated skin/cervical cancers), or a history of specific treatments like mTOR inhibitors.Check my eligibility
What is being tested?
The study tests if Amcenestrant improves progression-free survival compared to physician's choice of an endocrine monotherapy in patients with certain types of breast cancer. It also looks at overall survival rates, response rates, disease control, clinical benefits, duration of response based on ESR1 mutation status, drug pharmacokinetics, quality of life and safety profiles between the two treatment groups.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with hormone therapies such as hot flashes, fatigue, joint pain and nausea. There could also be risks related to lowering estrogen levels like bone thinning. The exact side effects will depend on the specific endocrine therapy chosen by the physician.

AMEERA-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer cannot be treated with radiation or surgery and may have spread.
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My cancer is estrogen receptor positive.
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I have had only one prior treatment for my advanced cancer.
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My breast cancer is diagnosed as adenocarcinoma.
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I am 18 years old or older.
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My cancer is not HER2 positive.
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I have previously been treated with a CDK 4/6 inhibitor, if it's approved and covered for me.
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My breast cancer worsened on hormone therapy after initial improvement.
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I am either male or female.

AMEERA-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores
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
+9 more

AMEERA-3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AmcenestrantExperimental Treatment1 Intervention
Daily amcenestrant dose administered orally under fed or fast condition
Group II: Fulvestrant/Aromatase inhibitors/Estrogen receptor modulatorActive Control5 Interventions
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)

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,513,981 Total Patients Enrolled
52 Trials studying Breast Cancer
24,229 Patients Enrolled for Breast Cancer
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,588 Total Patients Enrolled
11 Trials studying Breast Cancer
2,117 Patients Enrolled for Breast Cancer

Media Library

Amcenestrant (Selective Estrogen Receptor Degrader (SERD)) Clinical Trial Eligibility Overview. Trial Name: NCT04059484 — Phase 2
Breast Cancer Research Study Groups: Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator, Amcenestrant
Breast Cancer Clinical Trial 2023: Amcenestrant Highlights & Side Effects. Trial Name: NCT04059484 — Phase 2
Amcenestrant (Selective Estrogen Receptor Degrader (SERD)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04059484 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Amcenestrant undergone FDA approval process?

"While there is some evidence of Amcenestrant's safety, it is classified as a Phase 2 drug because there is no data supporting efficacy."

Answered by AI

For what reasons is Amcenestrant generally applied?

"Amcenestrant is frequently used to stop the worsening of a disease or condition. It is also approved by many regulatory bodies to treat conditions such as ovarian cancer, tamoxifen, and other malignant neoplasms."

Answered by AI

How many volunteers are being sought for this experiment?

"Unfortunately, this study has completed recruitment for clinical trial candidates. Although, there are 2366 trials for breast cancer and 326 for Amcenestrant that are still admitting patients."

Answered by AI

What is the precedent for Amcenestrant clinical trials?

"Currently, there are 326 ongoing clinical trials for Amcenestrant, with 87 of them in Phase 3. While most of the trials are located in Shanghai, there are a total of 18741 locations worldwide where clinical trials for Amcenestrant are taking place."

Answered by AI

Are there numerous research sites for this project?

"There are 42 locations where this clinical trial is taking place. Some of these are: Investigational Site Number :8400020 in Baton Rouge, Investigational Site Number :8400022 in Fort Worth, and Investigational Site Number :8400034 in Iowa City."

Answered by AI

Are we still recruiting individuals for this clinical research?

"As of right now, this clinical trial is not looking for new patients. According to the latest update on 4/28/2022, this study was first posted on 10/22/2019. If you are interested in other trials, there are 2366 trials for breast cancer and 326 trials for Amcenestrant that are currently recruiting."

Answered by AI
~68 spots leftby Mar 2025