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
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
Primary Objective:
To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.
Secondary Objective:
Study duration per participant was approximately 59 months, which includes a 33- month treatment period.
Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
CABA, Buenos Aires C1012AAR, Argentina
CABA, Buenos Aires C1019ABS, Argentina
Capital Federal, Buenos Aires C1417DTB, Argentina
Santaigo, Reg Metropolitana de Santiago 8241470, Chile
Kashiwa-shi, Chiba 277-8577, Japan
Kurume-shi, Fukuoka 830-0013, Japan
Takasaki-shi, Gunma 370-0829, Japan
Hidaka-shi, Saitama 350-1241, Japan
Koto-ku, Tokyo 135-8550, Japan
Meguro-ku, Tokyo 152-8902, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Krasnogorskiy District, 143423, Russia
Moscow Region, 143442, Russia
Seochogu, 6591, South Korea
Seongnam-si, Gyeonggi-do, 13496, South Korea
Barcelona / Sabadell, Castille and León 08208, Spain
Madrid / Madrid, Madrid, Comunidad de 28007, Spain
Madrid / Madrid, Madrid, Comunidad de 28050, Spain