Table 1.
Ongoing phase III trials, which evaluate the efficacy and safety of selective estrogen receptor degraders as breast cancer adjuvant therapy.
| Trial acronym, NCT number and sponsor | Study arms | Intervention duration | Previous ET duration | Patient population | Primary endpoint | CDK4/6 inhibitor and PARP inhibitor treatment | Recruitment status, estimated study completion |
|---|---|---|---|---|---|---|---|
| lidERA NCT04961996, Hoffmann-La Roche | Giredestrant versus TAM/AI | Giredestrant 5 years (other ET as per investigator discretion) | ≤ 12 weeks | Medium to high-risk, stage I–III | IDFS (excluding second non-primary BC) | Prohibited | Recruitment completed, estimated completion in 2033 |
| CAMBRIA-1 NCT05774951, AstraZeneca | Camizestrant versus TAM/AI | 5 years | 21–63 months | Medium to high-risk, stage I–III | IBCFS | Permitted | Recruiting, estimated completion in 2036 |
| CAMBRIA-2 NCT05952557, AstraZeneca | Camizestrant versus TAM/AI | 7 years | ≤ 12 weeks | Medium to high-risk, stage I–III | IBCFS | CDK4/6 inhibitor permitted, PARP inhibitor unknown | Recruiting, estimated completion in 2037 |
| EMBER-4 NCT05514054, Eli Lilly and Company | Imlunestrant versus TAM/AI | 5 years | 2–5 years | Medium to high-risk, stage I–III | IDFS excluding second non-breast primary invasive cancers | Permitted | Recruiting, estimated completion in 2032 |
| ELEGANT NCT06492616, Stemline Therapeutics | Elacestrant versus TAM/AI | 5 years | 2–5 years | Node-positive, high-risk | IBCFS | Permitted | Recruiting, estimated completion in 2032 |
Source: Data retrieved from www.clinicaltrials.org.
AI: aromatase inhibitor; BC: breast cancer; ET: endocrine therapy; IBCFS: invasive breast cancer-free survival; IDFS: invasive disease-free survival; NCT: National Clinical Trial; TAM: tamoxifen.