Spots Global Cancer Trial Database for Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
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Trial Identification
Brief Title: Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
Official Title: Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer
Study ID: NCT04191382
Conditions
Study Description
Brief Summary: Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole. Secondary Objectives: * To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested by immunohistochemistry greater than or equal to (\>=) 50 percent (%) (Ki67 \>=50%) in the three treatment arms. * To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms. * To assess safety in the three treatment arms.
Detailed Description: Duration of the study, per participant, would include screening period of up to 14 days before randomization, treatment period of 14 days and post-treatment safety follow-up period of 30±7 days after last investigational medicinal product (IMP) intake.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Investigational Site Number 8400014, Tucson, Arizona, United States
Investigational Site Number 8400010, Los Angeles, California, United States
Investigational Site Number 8400018, Fort Wayne, Indiana, United States
Investigational Site Number 8400005, Lincoln, Nebraska, United States
Investigational Site Number 8400016, Winston-Salem, North Carolina, United States
Investigational Site Number 8400012, Tacoma, Washington, United States
Investigational Site Number 0560001, Leuven, , Belgium
Investigational Site Number 0560002, Namur, , Belgium
Investigational Site Number 2500001, Nantes, , France
Investigational Site Number 2500004, Paris, , France
Investigational Site Number 2500002, Saint Cloud, , France
Investigational Site Number 2500003, Toulouse Cedex 9, , France
Investigational Site Number 3800004, Meldola, , Italy
Investigational Site Number 3800002, Milano, , Italy
Investigational Site Number 3800001, Milano, , Italy
Investigational Site Number 3920002, Osaka-Shi, , Japan
Investigational Site Number 3920003, Sapporo-Shi, , Japan
Investigational Site Number 3920001, Yokohama-Shi, , Japan
Investigational Site Number 8400007, Hato Rey, , Puerto Rico
Investigational Site Number 6430006, Moscow, , Russian Federation
Investigational Site Number 6430004, Moscow, , Russian Federation
Investigational Site Number 6430002, Saint -Petersburg, , Russian Federation
Investigational Site Number 6430003, Saint-Petersburg, , Russian Federation
Investigational Site Number 6430007, St.Petersburg, , Russian Federation
Investigational Site Number 7240005, Barcelona, , Spain
Investigational Site Number 7240003, Córdoba, , Spain
Investigational Site Number 7240001, Madrid, , Spain
Investigational Site Number 7240002, Valencia / Valencia, , Spain
Investigational Site Number 8040004, Kharkiv, , Ukraine
Investigational Site Number 8040001, Uzhgorod, , Ukraine
Investigational Site Number 8040002, Vinnytsia, , Ukraine
Investigational Site Number 8040005, Zaporizhzhya, , Ukraine
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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