Sanofi

AMEERA-5 | EFC15935

NCT04478266

JCP094

A Randomized, Multicenter, Double-blind Phase 3 Study of 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

Status:

Recruiting

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III

Phase

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1st

Line of Therapy

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Advanced / Metastatic

Disease Stage

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Biomarker(s)

ER+, HER2-

Investigational

Product

SAR439859

Selective Estrogen Receptor Degrader (SERD) (p.o.)

Treatment Arms

o Experimental:

SAR439859 + Palbociclib + Letrozole-matching placebo Arm

o Active Comparator:

SAR439859-matching placebo Arm + Palbociclib + Letrozole