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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07410559
Brief Summary:
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.
Detailed Description:
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer. Eligible subjects who provide informed consent will first receive a 2-week window-of-opportunity treatment with imlunestrant combined with abemaciclib, followed by a biopsy of the primary lesion to assess Ki67 at 2 weeks. If the Ki67 of the primary lesion after 2 weeks is \<7.4%, they will be randomized in a 1:1 ratio to either Imlunestrant plus abemaciclib or neoadjuvant chemotherapy. If the Ki67 of the primary lesion after 2 weeks is ≥7.4%, patients will be assigned to neoadjuvant chemotherapy.
Study:
NCT07410559
Study Brief:
Protocol Section:
NCT07410559