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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05501704 | ETHAN - ET for Male BC | PHASE2 | RECRUITING | 60 | — | — | Oct 11, 2023 | Apr 1, 2036 | Apr 30, 2026 | 8 | United States |
Ki-67 will be evaluated by ImmunoHistoChemistry (IHC) following consensus recommendations using imaging analysis methods.
RCB will be determined using data from each participating institution pathology department, and will be reviewed by the study team pathologist.
| Arm | Type | Description |
|---|---|---|
| Window Phase Arm A: Tamoxifen | EXPERIMENTAL | Participants will be randomly assigned to receive Tamoxifen 1x daily for 3 weeks (21days). |
| Window Phase Arm B: Anastrozole | EXPERIMENTAL | Participants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days). |
| Window Phase Arm C: Anastrozole + Degarelix | EXPERIMENTAL | Participants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days) and Degarelix on day 1 only. |
| Neoadjuvant Phase Arm D: Tamoxifen | EXPERIMENTAL | Participants will be randomly assigned to receive Tamoxifen 1x daily for 4 cycles (4 months); each study cycle is 28 days. |
| Neoadjuvant Phase Arm E: Tamoxifen + Abemaciclib | EXPERIMENTAL | Participants will be randomly assigned to receive Tamoxifen 1x daily and Abemaciclib 2x daily for 4 cycles (4 months); each study cycle is 28 days. |
| Neoadjuvant Phase Arm F: Anastrozole and Degarelix | EXPERIMENTAL | Participants will be randomly assigned to receive Anastrozole 1x daily and Degarelix on day 1 of each cycle for 4 cycles (4 months); each study cycle is 28 days. |
| Neoadjuvant Phase Arm G: Anastrozole + Degarelix + Abemaciclib | EXPERIMENTAL | Participants will be randomly assigned to receive Anastrozole 1x daily, Degarelix on day 1 of each cycle and Abemaciclib 2x daily for 4 cycles (4 months); each study cycle is 28 days. |
| Name | Type | Description |
|---|---|---|
| Tamoxifen | DRUG | Taken orally |
| Anastrozole | DRUG | Taken orally |
| Degarelix | DRUG | Subcutaneous (under the skin) injection |
| Abemaciclib | DRUG | Taken orally |
Inclusion Criteria: * Men aged 18 years or older, with diagnosis of invasive breast cancer who have not undergone surgical resection of the primary tumor and axillary nodes. * Stage I, II, or III per American Joint Committee on Cancer (AJCC) staging 8th edition (112). * Breast cancer must be hormon...