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AMEERA-5

  • Active, not recruiting

BOOG 2020-02

General Information

BOOG number

BOOG 2020-02

Nickname

AMEERA-5

Status

  • Active, not recruiting
Date: 16/08/2022

Inclusion closed

03/12/2021

Participating parties / group

Sanofi

Other study number

EFC15935

Full title

A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

Indication

  • Advanced/Metastatic

Subindication

HER2- HR+

Description

Amcenestrant plus Palbociclib vs Letrozole plus Palbociclib

Target sample size

1066 (global)

Actual accrual

1068 (NL:4)
Date: 09/12/2021

Estimated study completion date

01/05/2027

Contact

Sponsor

Sanofi

Central datamanagement and randomization

Sanofi

Monitoring

Sanofi

Funding

Sanofi

Design

A Randomized, Multicenter, Double-blind Phase 3 Study

Objectives

To determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Endpoints

Progression-free survival. Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever come first.

Eligibility Criteria

The most important inclusion criteria are:

  • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
  • Confirmed diagnosis of ER+/HER2- breast cancer
  • No prior systemic treatment for loco-regional recurrent or metastatic disease
  • Measurable or non-measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1.- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Participants should be willing to provide tumor tissue

 

The most important exclusion criteria are:

  • Known brain metastases that are untreated, symptomatic or require treatment to control symptoms
  • Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
  • Inadequate organ and marrow function
  • Disease recurrence while on, or within 12 months of completion of (neo)adjuvant aromatase inhibitor-containing therapy
  • Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
  • Male participants who disagree to follow contraception
  • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
  • Participants with significant concomitant illness

Regulatory Information

CCMO approval

Yes
Date: 02/09/2020

EC approval

Yes
Date: 10/11/2020
Nr:20-073

EudraCT number

2020-001824-33

Trial Register

NCT04478266

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