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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04964934 | Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) | PHASE3 | ACTIVE NOT_RECRUITING | 315 | — | — | Jun 30, 2021 | Sep 1, 2028 | Apr 21, 2026 | 265 | United States, Australia +21 |
| NCT04711252 | A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease | PHASE3 | ACTIVE NOT_RECRUITING | 1,370 | — | — | Jan 28, 2021 | Feb 1, 2029 | Oct 14, 2025 | 263 | United States, Austria +25 |
PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST 1.1) or death.
PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death.
| Arm | Type | Description |
|---|---|---|
| AZD9833 + palbociclib, abemaciclib or ribociclib | EXPERIMENTAL | The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150,100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (PO, once daily) or letrozole placebo (PO, once daily) |
| Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib | ACTIVE_COMPARATOR | The patients will recieve anastrozole (1 mg, PO, once daily) or letrozole (2.5 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150, 100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily) |
| AZD9833 + palbociclib | EXPERIMENTAL | The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (1 mg, PO, once daily) |
| Anastrozole + palbociclib | ACTIVE_COMPARATOR | The patients will recieve Anastrozole (1 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily) |
| Name | Type | Description |
|---|---|---|
| AZD9833 | DRUG | Dosage formulation: AZD9833 tablets will be administered orally |
| AZD9833 Placebo | DRUG | Dosage formulation: AZD9833 placebo tablets will be administrated orally. |
| Anastrozole | DRUG | Dosage formulation: anastrozole tablets will be administered orally. |
| Anastrozole placebo | DRUG | Dosage formulation: anastrozole placebo tablets will be administrated orally. |
| Letrozole | DRUG | Dosage formulation: letrozole tablets will be administered orally. |
| Letrozole placebo | DRUG | Dosage formulation: letrozole placebo tablets will be administered orally. |
| Palbociclib | DRUG | Dosage formulation: palbociclib tablets/capsules will be administered orally |
| Abemaciclib | DRUG | Dosage formulation: abemaciclib tablets will be administered orally |
| Luteinizing hormone-releasing hormone (LHRH) agonist | DRUG | Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist. |
| Ribociclib | DRUG | Dosage formulation: ribociclib tablets will be administered orally |
INCLUSION CRITERIA: INFORMATION FOR TRIAL PARTICIPANTS - Participants can join the trial if they: * Have advanced breast cancer that is not able to be treated with surgery or radiation; * Have an ESR1 mutation in their cancer; * Have breast cancer that is HR-positive and HER2-negative; * Are curre...