Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT04478266
Brief Summary:
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:
* To compare the overall survival in both treatment arms.
* To evaluate the objective response rate in both treatment arms.
* To evaluate the duration of response in both treatment arms.
* To evaluate the clinical benefit rate in both treatment arms.
* To evaluate progression-free survival on next line of therapy.
* To evaluate the pharmacokinetics of amcenestrant, and palbociclib.
* To evaluate health-related quality of life in both treatment arms.
* To evaluate the time to first chemotherapy in both treatment arms.
* To evaluate safety in both treatment arms.
Detailed Description:
Study duration per participant was approximately 59 months, which includes a 33- month treatment period.
Study:
NCT04478266
Study Brief:
Protocol Section:
NCT04478266