Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Degarelix · 1 trial · 3 indications
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...
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Degarelix is being studied for the treatment of male breast cancer, specifically in hormone receptor-positive breast cancer and hormone receptor negative breast carcinoma. It is an investigational small molecule in Phase 2 clinical development for this indication, and it is not yet approved by the FDA.
Degarelix is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in male breast cancer.
Degarelix is currently in Phase 2 clinical development for male breast cancer. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness.
Degarelix is being evaluated in a Phase 2 clinical trial with the identifier NCT05501704, titled "ETHAN - ET for Male BC." This trial is currently recruiting participants in the United States and is expected to enroll 60 male patients aged 18 years and older.
Degarelix is also known by the brand name Firmagon, which is a gonadotropin-releasing hormone receptor antagonist. In the context of male breast cancer, it is being investigated under the name Degarelix in clinical trials.