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Degarelix

Phase 2

Male Breast Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Aug 24, 2026

Target and mechanism

Molecular targetGNRHR
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Degarelix · 1 trial · 3 indications

Phase 2 1
NCT05501704ETHAN - ET for Male BCMale Breast Cancer
RECRUITING60 Analytics
PHASE2RECRUITING
ETHAN - ET for Male BC
Male Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Ki-67
At the end of the 3-week window period.

Ki-67 will be evaluated by ImmunoHistoChemistry (IHC) following consensus recommendations using imaging analysis methods.

RCB index
At time of surgery.

RCB will be determined using data from each participating institution pathology department, and will be reviewed by the study team pathologist.

Secondary Endpoints

Changes in estradiol levels
Baseline and at the end of the three-week window period
Changes in testosterone levels
Baseline and at the end of the three-week window period
Preoperative Endocrine Prognostic Index (PEPI) score
At time of surgery
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Window Phase Arm A: TamoxifenEXPERIMENTALParticipants will be randomly assigned to receive Tamoxifen 1x daily for 3 weeks (21days).
Window Phase Arm B: AnastrozoleEXPERIMENTALParticipants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days).
Window Phase Arm C: Anastrozole + DegarelixEXPERIMENTALParticipants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days) and Degarelix on day 1 only.
Neoadjuvant Phase Arm D: TamoxifenEXPERIMENTALParticipants 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 + AbemaciclibEXPERIMENTALParticipants 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 DegarelixEXPERIMENTALParticipants 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 + AbemaciclibEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
TamoxifenDRUGTaken orally
AnastrozoleDRUGTaken orally
DegarelixDRUGSubcutaneous (under the skin) injection
AbemaciclibDRUGTaken orally
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites9

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...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials (matched to "Male Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT05501704lastUpdatePostDate: changed
LOWAug 24, 2026NCT05501704lastUpdatePostDate: changed

Frequently asked questions about Degarelix

What is Degarelix used for in male breast cancer?

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.

Who is developing Degarelix?

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.

What phase is Degarelix in for 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.

What clinical trials is Degarelix in?

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.

Is Degarelix the same as any other drug?

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.