Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04055493 | Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC | PHASE3 | ACTIVE NOT_RECRUITING | 1,684 | — | — | Jul 2, 2019 | Jul 31, 2027 | Aug 26, 2025 | 86 | Germany |
superiority in invasive disease-free survival (iDFS) of ribociclib + ET vs. standard-of-care chemotherapy
distant disease-free survival (dDFS) in the ribociclib + ET-group to demonstrate survival rate \>92%
| Arm | Type | Description |
|---|---|---|
| Ribociclib plus ET | EXPERIMENTAL | Ribociclib 600mg / day over 26 cycles + endocrine treatment of physician´s choice |
| Standard-of-care chemotherapy | NO_INTERVENTION | Standard-of-care chemotherapy according to the clinical guidelines, e.g., of the Breast Committee of the German Gynecological Oncology Group (AGO), and regional prescribing information depending on patient's needs for 16-24 weeks, |
| Name | Type | Description |
|---|---|---|
| Ribociclib 200Mg Oral Tablet | DRUG | 3 x 200 MG per os |
Inclusion Criteria: Patients eligible for inclusion in this study have to meet all of the following criteria: A. Prior to REGISTRATION in the study: 1\. Written informed consent prior to any screening procedures. 2. Female. 3. ≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of ...