← Back to Search

Amcenestrant Combinations for Breast Cancer (AMEERA-1 Trial)

Phase 1 & 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

Either primary tumor or any metastatic site to be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor

Locally advanced or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and one assessment in cycle 1 on day 11 to 15 (each cycle is 28 days)

Awards & highlights

AMEERA-1 Trial Summary

This trial is testing a new drug, amcenestrant, to see if it is safe and effective for treating breast cancer. The trial will test different doses of amcenestrant to find the maximum tolerated dose (MTD), and will also test amcenestrant in combination with other drugs to see if it is safe and effective.

Who is the study for?

This trial is for postmenopausal women with advanced breast cancer that's ER+ and HER2-. Participants can have had limited prior endocrine or chemotherapy treatments, depending on the study arm. They must not have severe concurrent illnesses, certain drug interactions, or a history of specific conditions like uncontrolled diabetes or brain metastases.Check my eligibility

What is being tested?

The trial tests Amcenestrant alone and in combination with other anti-cancer drugs (Palbociclib, Alpelisib, Everolimus, Abemaciclib) to find safe dosages and assess their effectiveness against breast cancer. It includes dose escalation to determine maximum tolerated doses and expansion phases to evaluate antitumor activity.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, fatigue, digestive issues like nausea or diarrhea, blood-related problems such as anemia or clotting disorders. There could also be increased risk of infections due to immune system suppression.

AMEERA-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is positive for estrogen receptors and negative for HER2.

Select...

My cancer has spread beyond its original location.

Select...

I have advanced disease and my first treatment was with Aromatase Inhibitors and CDK4/6 inhibitors.

Select...

I have had no more than 2 prior endocrine treatments for my advanced disease.

Select...

I am a woman who has gone through menopause.

Select...

My breast cancer is diagnosed as adenocarcinoma.

Select...

I have been treated with hormone therapy for my advanced disease for at least 6 months.

Select...

I have advanced disease and my first treatment was AI + CDK4/6 Inhibitor, but not exemestane.

AMEERA-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and one assessment in cycle 1 on day 11 to 15 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and one assessment in cycle 1 on day 11 to 15 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one assessment in cycle 1 on day 11 to 15 (each cycle is 28 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

Dose Limiting Toxicities (DLTs)

Objective Response Rate (ORR)

Secondary outcome measures

AUC0-24 of abemaciclib after repeated dose administration

AUC0-24 of abemaciclib after single dose

AUC0-24 of alpelisib after repeated dose administration

+39 more

AMEERA-1 Trial Design

5Treatment groups

Experimental Treatment

Group I: Amcenestrant/Palbociclib: Arm #2 Part C Dose Escalation, Part D Dose ExpansionExperimental Treatment2 Interventions

Part C: Amcenestrant will be administered in combination with palbociclib: amcenestrant starting oral daily dose will be one dose level below monotherapy RD and palbociclib will be dosed at fixed standard dose. Administration of higher dose of amcenestrant (with standard palbociclib dose) to subsequent participants will be based on occurrence of DLTs at initial and subsequent doses, until MAD of amcenestrant is reached. Drugs will be administered in a 28-day cycle (palbociclib will be administered for 21 days of cycle). Part D: Based on the results in Part C, participants will be administered either: 1) a determined amcenestrant dose (RD) with standard dose of palbociclib in combination therapy, or 2) one of two randomized dose levels of amcenestrant with standard dose of palbociclib in combination therapy. Drugs will be administered in a 28-day cycle (palbociclib will be administered for 21 days of cycle).

Group II: Amcenestrant/Everolimus: Arm #4 Part H Dose Escalation, Part I Dose ExpansionExperimental Treatment2 Interventions

Part H: Amcenestrant will be administered at the determined RD in combination with 2 dose levels of everolimus. Additional dose levels of amcenestrant with everolimus could be explored if needed based on the safety and PK results. Both amcenestrant and everolimus will be administered in a 28-day cycle. Part I: Based on the conclusion in Part H, participants will be administered the determined RD of amcenestrant and RD of everolimus given in the combination in an expansion cohort. Both study drugs will be administered in a 28-day cycle.

Group III: Amcenestrant/Alpelisib: Arm #3 Part F Safety Run-In, Part G Dose ExpansionExperimental Treatment2 Interventions

Part F: Amcenestrant will be administered in combination with alpelisib at a fixed standard dose. Additional dose levels of amcenestrant with alpelisib could be explored if needed based on the safety and PK results. Lower dose of alpelisib could be explored based on the PK results and safety profile from the initial combination administration. Both amcenestrant and alpelisib will be administered in a 28-day cycle. Part G: Based on the conclusion in Part F, participants will be administered the determined RD of amcenestrant and alpelisib given in the combination in an expansion cohort. Both study drugs will be administered in a 28-day cycle.

Group IV: Amcenestrant/Abemaciclib: Arm #5 Part J Dose Escalation, Part K Dose ExpansionExperimental Treatment2 Interventions

Part J: Amcenestrant will be administered at the determined RD in combination with 2 dose levels of abemaciclib. Additional dose levels of amcenestrant with abemaciclib could be explored if needed based on the safety and PK results. Both amcenestrant and abemaciclib will be administered in a 28-day cycle. Part K: Based on the conclusion in Part J, participants will be administered the determined RD of amcenestrant and RD of abemaciclib given in the combination in an expansion cohort. Both study drugs will be administered in a 28-day cycle.

Group V: Amcenestrant Monotherapy: Arm #1 Part A Dose Escalation, Part B Dose ExpansionExperimental Treatment1 Intervention

Part A: Amcenestrant will be administered orally once daily (QD). Treatment will begin with an identified starting dose. Administration of higher doses to subsequent participants is based on occurrence of DLTs and evaluation of target saturation and PK parameters at initial and subsequent doses, until maximum administered dose (MAD) is reached. Drug will be administered in a 28-day cycle. Part B: When the dose escalation phase ends, the recommended dose will be administered for the expansion cohort. Drug will be administered in a 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alpelisib

2018

Completed Phase 3

~900

Everolimus

2010

Completed Phase 4

~1510

Palbociclib

2017

Completed Phase 3

~3760

Abemaciclib

2019

Completed Phase 2

~1710

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,844 Total Patients Enrolled

51 Trials studying Breast Cancer

24,093 Patients Enrolled for Breast Cancer

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,702 Total Patients Enrolled

10 Trials studying Breast Cancer

1,981 Patients Enrolled for Breast Cancer

Media Library

Palbociclib Clinical Trial Eligibility Overview. Trial Name: NCT03284957 — Phase 1 & 2

Breast Cancer Research Study Groups: Amcenestrant/Palbociclib: Arm #2 Part C Dose Escalation, Part D Dose Expansion, Amcenestrant Monotherapy: Arm #1 Part A Dose Escalation, Part B Dose Expansion, Amcenestrant/Abemaciclib: Arm #5 Part J Dose Escalation, Part K Dose Expansion, Amcenestrant/Alpelisib: Arm #3 Part F Safety Run-In, Part G Dose Expansion, Amcenestrant/Everolimus: Arm #4 Part H Dose Escalation, Part I Dose Expansion

Breast Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT03284957 — Phase 1 & 2

Palbociclib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03284957 — Phase 1 & 2

Frequently Asked Questions

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

What is the scope of participants enrolled in this investigation?

"Unfortunately, this trial has already concluded its recruitment period. It was first announced on September 20 2017 and last updated on the 21st of September 2022. However, there are 2600 trials recruiting for breast cancer patients and 322 studies accepting applications to test Palbociclib efficacy."

Answered by AI

What positive outcomes is this trial attempting to manifest?

"As per the trial's sponsor Sanofi, this clinical study will be evaluating Dose Limiting Toxicities (DLTs) as its main outcome over a predetermined period of time. Secondary endpoints being assessed include Cmax after third dose, Progression Free Survival based on RECIST 1.1 criteria, and AUC0-24 for amcenestrant following repeated doses in all treatment arms."

Answered by AI

Are there any other precedents of Palbociclib being used in clinical studies?

"Palbociclib was initially tested in 2008 at Sheba Medical Center, and since then 533 trials have been completed. Presently there are 322 ongoing clinical studies of which many are conducted within Boston, Massachusetts."

Answered by AI

To what extent are hospitals facilitating this research endeavor?

"An assortment of 16 medical trial sites are presently enrolling participants, such as Investigational Site Number 8400102 in Boston, Investigational Site Number 1240005 in Montreal and the aforementioned Toronto location (Investigational Site 8400002)."

Answered by AI

Is enrollment currently available for this research endeavor?

"Unfortunately, this specific clinical trial is no longer accepting patients. The initial post was made on September 20th 2017 with the latest edit occurring on September 21st 2022. Breast cancer sufferers have access to 2,600 other trials while Palbociclib users may choose from 322 studies currently enrolling participants."

Answered by AI

To what conditions is Palbociclib usually prescribed?

"Palbociclib is frequently used to treat organ rejection and kidney transplantation. Additionally, this medication can benefit patients with waldenstrom macroglobulinemia, lung malignancy, and advanced carcinoid tumor."

Answered by AI