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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

Must not have

Treatment with drugs that have the potential to inhibit Uridine'5 Diphospho-Glucuronosyl Transferase(UGT) less than 2 weeks before randomization

Inadequate hematological, coagulation, renal and liver functions

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

No Placebo-Only Group

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.

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.

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.

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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My breast cancer worsened on hormone therapy after initial improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken drugs that affect UGT in the last 2 weeks.

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My blood, clotting, kidney, and liver functions are not within normal ranges.

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I do not have any severe illnesses that are not under control.

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I have significant difficulty with self-care.

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I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.

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I haven't taken any cancer drugs in the last 3 weeks.

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I am currently taking medication that affects my body's drug transport system.

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I have no stomach or bowel problems that affect medication absorption.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 15Eligibility criteria met