Studieoverzicht - 2020-02 AMEERA-5

 
Number 2020-02 AMEERA-5
Nickname AMEERA-5
Status Open Date: 04-01-2021
Inclusion closed
Other study number(s) EFC15935
Participating parties/groups Sanofi
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
Phase and type Randomized Phase III
Age ≥ 18 years
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 1066 (global)
Actual accrual Date:
Estimated study completion date 01-05-2027
CCMO approval Yes Date: 02-09-2020 Nr:
EudraCT nr. 2020-001824-33
Trial Register
METC approval Yes Date: 10-11-2020 METC: Nr: 20-073
Amendments Date:
KWF-CKS approval Date: Nr:
News item
Website
Sponsor Sanofi
Principal Investigator(s)
Study manager
Central datamanagement and randomization Sanofi
Monitoring Sanofi
Local datamanagement
Funding Sanofi
Extra

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.

Main 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

Documents (public):

Deelnemende centra:

Maastricht UMC+ 

Spaarne Gasthuis Hoofddorp 

Reinier de Graaf Gasthuis

Rijnstate Arnhem 

Amphia ziekenhuis, Breda

 

Documents (protected):
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