drugset / Trial / NCT07428018
Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib
Phase 2
Not yet recruiting
150 enrolled
Mario Negri Institute for Pharmacological Research
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · collabHumanitas Research Hospital IRCCS, Rozzano-Milan · collabIEO Foundation · collabIRCCS San Raffaele · collabPapa Giovanni XXIII Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2026-04-30
- Primary completion
- 2029-04-30
- Completion
- 2029-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | — |