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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05952557 | An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) | PHASE3 | RECRUITING | 5,500 | — | — | Oct 5, 2023 | May 6, 2037 | May 28, 2026 | 794 | United States, Argentina +42 |
| NCT05774951 | A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy | PHASE3 | RECRUITING | 4,300 | — | — | Mar 31, 2023 | May 29, 2036 | May 8, 2026 | 711 | United States, Argentina +37 |
IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Death attributable to any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib | ACTIVE_COMPARATOR | standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib |
| Arm B: camizestrant ± abemaciclib | EXPERIMENTAL | camizestrant ± abemaciclib |
| Arm A: standard endocrine therapy of investigator´s choice | ACTIVE_COMPARATOR | Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) |
| Arm B: camizestrant | EXPERIMENTAL | Camizestrant |
| Name | Type | Description |
|---|---|---|
| Camizestrant | DRUG | Camizestrant. Experimental. Administered orally |
| Tamoxifen | DRUG | Tamoxifen. Comparator. Administered orally |
| Anastrozole | DRUG | Anastrozole. Comparator. Administered orally |
| Letrozole | DRUG | Letrozole. Comparator. Administered orally |
| Exemestane | DRUG | Exemestane. Comparator. Administered orally |
| Abemaciclib | DRUG | Abemaciclib adjuvant treatment Administered orally |
Inclusion Criteria: * Women and Men; ≥18 years at the time of screening (or per national guidelines) * Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol. * Completed adequate (definitive) loco...