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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05207709 | Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype | PHASE3 | ACTIVE NOT_RECRUITING | 456 | — | — | Mar 28, 2022 | Mar 1, 2027 | Apr 29, 2025 | 71 | United States, Portugal +1 |
| NCT02632045 | Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer | PHASE2 | COMPLETED | 169 | — | — | Mar 1, 2016 | Jan 4, 2022 | Dec 6, 2024 | 13 | United States |
using RECIST 1.1 criteria, as assessed by local radiologists/investigators
Progression free survival (PFS) is defined as the interval from the time of randomization until objective disease progression (local assessment) or death from any cause. Disease status will be assessed with comprehensive radiographic studies every three treatment cycles (approximately every 12 weeks (+/- 1 week)). Disease progression as assed by RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
| Arm | Type | Description |
|---|---|---|
| Ribociclib + Endocrine Therapy | EXPERIMENTAL | Ribociclib + Fulvestrant or Letrozole |
| Palbociclib + Endocrine Therapy | EXPERIMENTAL | Palbociclib + Fulvestrant or Letrozole |
| Paclitaxel +/- Tislelizumab - Exploratory cohort | EXPERIMENTAL | Additional experimental Cohort that includes patients with Basal-Like intrinsic subtype. |
| Ribociclib (LEE-011)/Fulvestrant | EXPERIMENTAL | LEE-011 is administered orally, 600mg, daily for 3 weeks and 1 week off. Fulvestrant is administered intramuscularly, 500mg, every 2 weeks x 3, then every 4 weeks. |
| Placebo/Fulvestrant | PLACEBO_COMPARATOR | Placebo is administered orally, 600mg daily for 3 weeks and 1 week off. Fulvestrant is administered intramuscularly, 500mg, every 2 weeks x 3, then every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Ribociclib + Letrozole OR Fulvestrant | DRUG | Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks |
| Palbociclib + Letrozole OR Fulvestrant | DRUG | Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks |
| Paclitaxel +/- Tislelizumab | DRUG | Patients in this arm could receive as the first line of therapy |
| LEE-011 | DRUG | 600 mg capsule (3x 200 mg capsules) |
| Fulvestrant | DRUG | 500 mg injection |
| Placebo | DRUG | 600 mg capsule (3x 200 mg capsules) |
Main Inclusion Criteria: * Histologically documented HR-positive and HER2-negative breast cancer by local testing * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer. * Availabi...