Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:38 AM
Study NCT ID:
NCT07428018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Study Overview
Official Title:
The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIOLET
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2026-525457-37-00 | CTIS | None | View |