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 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07428018
Brief Summary:
This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy
Detailed Description:
Women aged 18 years or older with histologically confirmed operable or inoperable ER-positive (\>10%)/HER2-negative invasive breast carcinoma (stage II-IIIB), candidate to receive neoadjuvant chemotherapy according to the shared decision of a multidisciplinary tumor board, and who are not eligible to receive upfront breast conservative surgery AND/OR are candidate to lymph node. All eligible patients will undergo ODX RS tumor assessment in the baseline biopsy. They will receive NET plus abemaciclib or NCT for 6 months as per MDT decision, according to tumor stage, tumor histology, patient menopausal status and ODX RS results. At the end of the neoadjuvant treatment, all patients will be discussed again in a multidisciplinary tumor board and a new surgical indication will be given according to the post-treatment clinical and radiological assessment.After surgery, patients who received NET+abemaciclib may receive adjuvant chemotherapy according to the multidisciplinary tumor board indication.dissection.
Study:
NCT07428018
Study Brief:
Protocol Section:
NCT07428018