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    DRUG CLASS:

    Androgen receptor modulator

    Related drugs:
    18d
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=90, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Ostarine (enobosarm)
    2ms
    Phase II Study of GTx024 in Women With Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=22, Terminated, GTx | Completed --> Terminated
    Trial termination • Metastases
    |
    ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • AR positive
    |
    Ostarine (enobosarm)
    3ms
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Veru Inc.
    New P2 trial
    |
    Ostarine (enobosarm)
    3ms
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=5, Terminated, Veru Inc. | N=186 --> 5
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    3ms
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=18, Completed, City of Hope Medical Center | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression • PGR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    3ms
    Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): a randomised, open-label, multicentre, multinational, parallel design, phase 2 trial. (PubMed, Lancet Oncol)
    Enobosarm has anti-tumour activity in patients with ER-positive, HER2-negative advanced breast cancer, showing that AR activation can result in clinical benefit, supporting further clinical investigation of selective AR activation strategies for the treatment of AR-positive, ER-positive, HER2-negative advanced breast cancer.
    P2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • AR positive • ER positive + HER-2 negative
    |
    Ostarine (enobosarm)
    4ms
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Suspended, Veru Inc. | Trial completion date: Jan 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    4ms
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=52, Terminated, Veru Inc. | N=210 --> 52 | Active, not recruiting --> Terminated; Business decision
    Enrollment change • Trial termination • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    4ms
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Suspended, Veru Inc. | Active, not recruiting --> Suspended | Trial primary completion date: Sep 2023 --> Jan 2024
    Trial suspension • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    7ms
    Clinical Results of Subjects Remaining in the Phase 3 ARTEST Study Enobosarm Therapy in AR+ER+HER2- Metastatic Breast Cancer with 3 or Greater Prior Lines of Therapy (SABCS 2023)
    Activity of enobosarm in this heavily pretreated patient population is encouraging and supports further clinical investigation. The Phase 3 ENABLAR-2 study is underway to further evaluate enobosarm alone or in combination with abemaciclib for the second-line treatment of AR+ER+HER2- metastatic breast cancer in patients who have received a prior estrogen blocking agent and a CDK 4/6 inhibitor. Clinical trial information: NCT04869943.
    Clinical • P3 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • AR positive
    |
    Verzenio (abemaciclib) • Ostarine (enobosarm)
    8ms
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Active, not recruiting, Veru Inc. | Trial completion date: Jul 2023 --> Feb 2024 | Trial primary completion date: Jun 2023 --> Jan 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    8ms
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    10ms
    A GATA2-CDC6 axis modulates androgen receptor blockade-induced senescence in prostate cancer. (PubMed, J Exp Clin Cancer Res)
    We identify a key GATA2-CDC6 signaling axis which is reciprocally regulated in enzalutamide-sensitive and -resistant prostate cancer environments. Upon acquired resistance, GATA2 repression leads to CDC6 stabilization, with detrimental effects in disease progression through exacerbation of EMT and abrogation of senescence. However, bypassing the GATA2-CDC6 axis by direct inhibition of CDC6 reverses oncogenic features and establishes senescence, thereby offering a therapeutic window even after acquiring resistance to therapy.
    Journal
    |
    AR (Androgen receptor) • GATA2 (GATA Binding Protein 2) • CDC6 (Cell Division Cycle 6)
    |
    Xtandi (enzalutamide capsule)
    10ms
    A multivalent peptoid conjugate modulates androgen receptor transcriptional activity to inhibit therapy-resistant prostate cancer. (PubMed, Mol Cancer Ther)
    In xenograft studies, MPC309 produced significantly greater tumor suppression than enzalutamide. Altogether, MPC309 represents a promising new AR modulator that can combat resistant disease by promoting an AR anti-proliferative gene expression program.
    Journal
    |
    AR (Androgen receptor)
    |
    AR expression
    |
    Xtandi (enzalutamide capsule)
    10ms
    In vitro anti-carcinogenic effect of andarine as a selective androgen receptor modulator on MIA-PaCa-2 cells by decreased proliferation and cell-cycle arrest at G0/G1 phase. (PubMed, Biochem Biophys Res Commun)
    Furthermore, we established that the anti-carcinogenic activity of andarine is not mediated by the PI3K/AKT/mTOR signaling pathway, a crucial regulator of cell survival. Our findings suggest that andarine might be considered as a prospective drug for PC.
    Preclinical • Journal
    |
    CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    1year
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jan 2023 --> Dec 2023
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression • PGR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    1year
    A Selective Androgen Receptor Modulator, S4, Displays Robust Anti-cancer Activity on Hepatocellular Cancer Cells by Negatively Regulating PI3K/AKT/mTOR Signaling Pathway. (PubMed, Gene)
    Since PI3K/AKT/mTOR signaling is frequently activated in HCC and contributes to its aggressiveness and poor prognosis, its negative regulation by the downregulation of critical components via S4 was a prominent finding. Further studies are necessary to investigate the S4 action mechanism and anti-tumorigenic capacity in in-vivo.
    Journal
    1year
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Active, not recruiting, Veru Inc. | Trial completion date: Apr 2023 --> Jul 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    1year
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=210, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    1year
    β3-adrenergic receptor on tumor-infiltrating lymphocytes sustains IFN-γ-dependent PD-L1 expression and impairs anti-tumor immunity in neuroblastoma. (PubMed, Cancer Gene Ther)
    Further investigations, through a genomic analysis on NB patients, showed that high ADRB3 gene expression correlates with worse clinical outcome compared to the low expression group, and that ADRB3 gene expression affects different immune-related pathways. Overall, results indicate that β3-AR in NB TME is able to modulate the interaction between tumor and host immune system, and that its antagonism hits multiple pro-tumoral signaling pathways.
    Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma)
    |
    PD-L1 expression • IFNG expression
    over1year
    Modulating the Activity of Androgen Receptor for Treating Breast Cancer. (PubMed, Int J Mol Sci)
    Nevertheless, several issues still need to be addressed, such as the lack of standardization in the determination of AR positivity and the presence of AR splice variants. In future, the inclusion of the AR status in the breast cancer report at the time of diagnosis might help improve disease classification and treatment decision, thereby providing additional treatment strategies for breast cancer.
    Review • Journal
    |
    ER (Estrogen receptor) • AR (Androgen receptor)
    |
    AR positive
    over1year
    A phase 1/2 study to evaluate the safety and efficacy of EP0062, an oral Selective Androgen Receptor Modulator (SARM), for the treatment of AR+/HER2-/ER+ advanced breast cancer (SABCS 2022)
    Clinic follow-up will be at 2 and 4 weeks, then every 4 weeks until disease progression. Recruitment is scheduled to initiate in Q4 2022.
    Clinical • P1/2 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • AR expression
    |
    vosilasarm (EP0062)
    over1year
    Characterizing the HER2-/Immune-/DNA repair (DRD-) response predictive breast cancer subtype: the hunt for new protein targets in a high-needs population with low response to all I-SPY2 agents (SABCS 2022)
    HR+HER2- and TN patients who are Immune-Low and DRD-Low have very low pCR rates to all tested therapeutics in I-SPY2 including standard chemotherapy, platinum, and immunotherapy. Senolytics (possibly targeting Cyclin D1), HER2low agents, and AR modulators may overcome resistance in HR+HER2- /Immune-/DRD-, whereas an immune activator beyond checkpoint inhibition is suggested for TN/Immune-/DRD- patients. [1] Wolf et.
    Clinical • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • CCND1 (Cyclin D1) • CCNB1 (Cyclin B1)
    |
    HER-2 negative
    over1year
    Differential DNA-binding and cofactor recruitment are possible determinants of the synthetic steroid YK11-dependent gene expression by androgen receptor in breast cancer MDA-MB 453 cells. (PubMed, Exp Cell Res)
    The results of this study suggest that gene selective regulation by SARMs results from differential DNA-binding and/or cofactor recruitment by ligands. These results provide novel insights into the mechanism of action of SARMs.
    Journal • Epigenetic controller
    |
    AR (Androgen receptor)
    |
    AR positive • AR expression
    almost2years
    Effect of Selective Androgen Receptor Modulator on Cholesterol Efflux Capacity, Size, and Subspecies of HDL Particles. (PubMed, J Endocr Soc)
    To determine the effects of an oral SARM (OPK-88004) on cholesterol efflux capacity, HDL particle number and size, apolipoprotein particle number and size and HDL subspecies...SARM-induced increase in HTGL could contribute to HDL-C suppression. These data do not support the simplistic notion that SARM-associated suppression of HDL-C is necessarily proatherogenic; randomized trials are needed to determine SARM's effects on cardiovascular events.
    Journal
    |
    APOA1 (Apolipoprotein A-I) • APOB (Apolipoprotein B) • APOE (Apolipoprotein E)
    |
    OPK 88004
    almost2years
    Antitumor activity of the SARM RAD140 in hormone-independent estrogen receptor-positive breast cancer patient-derived xenografts (EACR 2022)
    In vivo antitumor activity of RAD140 alone or in combination with palbociclib was tested in comparison to fulvestrant plus palbociclib. Conclusion RAD140 exhibits antitumor activity in hormone-independent and ESR1 -altered ER+/HER2- PDX models as single agent or in combination with CDK4/6i. Mechanistically, AR agonists decrease proliferation as shown by a decrease in Ki67 and S/G2-cell cycle cyclin levels.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • AR (Androgen receptor) • CCNA2 (Cyclin A2) • E2F1 (E2F transcription factor 1)
    |
    ER positive • HER-2 negative • HER-2 mutation • ESR1 mutation • AR expression
    |
    MSK-IMPACT
    |
    Ibrance (palbociclib) • fulvestrant • vosilasarm (EP0062)
    almost2years
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | N=29 --> 18 | Trial completion date: Nov 2021 --> Jan 2023
    Enrollment change • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression • PGR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    almost2years
    TiP. Randomized, Multicenter, International Phase 3 ARTEST Study to Evaluate the Efficacy and Safety of Enobosarm Versus Active Control for the Treatment of AR+, ER+, HER2– Metastatic Breast Cancer in Patients Who Previously Received an Estrogen-Blocking Agent and CDK4/6 Inhibitor (MBCC 2022)
    Approximately 210 subjects with AR+, ER+, HER2– mBC and with AR nuclei staining of 40% or greater are being randomized 1:1 to either enobosarm 9-mg oral daily dose or an active comparator (either exemestane, everolimus [Afinitor], or a selective estrogen receptor modulator; physician’s choice). The secondary objectives/end points of this study include the objective response rate, duration of response, overall survival, change from baseline in Short Physical Performance Battery (SPPB), and change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). Status The study is currently ongoing, and it is anticipated that enrollment will be completed this year
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • AR positive • AR expression
    |
    everolimus • exemestane • Ostarine (enobosarm)
    almost2years
    TiP. Randomized, Multicenter, Phase 3 Study to Evaluate the Combination of Enobosarm and Abemaciclib Compared With Estrogen-Blocking Agent for the Second-Line Treatment of AR+, ER+, HER2– Metastatic Breast Cancer in Patients Who Have Previously Received Palbociclib and an Estrogen-Blocking Agent Combination Therapy (MBCC 2022)
    If first-line therapy for mBC was a nonsteroidal aromatase inhibitor (AI) plus palbociclib (Ibrance), then the patient is randomized to either enobosarm plus abemaciclib (Verzenio) or fulvestrant. Secondary end points include objective response rate, duration of response, overall survival, change from baseline in Short Physical Performance Battery (SPPB), change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ), and change in body composition as measured by dual-energy x-ray absorptiometry (DEXA). Status The study is currently ongoing, and it is anticipated that enrollment will be completed this year.
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • AR positive • AR negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • fulvestrant • Ostarine (enobosarm)
    2years
    Transcriptome profiling and proteomic validation reveals targets of the androgen receptor signaling in the BT-474 breast cancer cell line. (PubMed, Clin Proteomics)
    Our findings suggest that AR modulates the metabolism of BT-474 cells by affecting the expression of a large number of genes and proteins. Based on further pathway analysis, we suggest that androgen receptor acts as a tumor suppressor in the BT-474 cells.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor) • KLK2 (Kallikrein-related peptidase 2) • ZBTB16 (Zinc Finger And BTB Domain Containing 16) • KLK3 (Kallikrein-related peptidase 3)
    2years
    The effect of PARP inhibition on androgen receptor localization and activity in castration resistant prostate cancer. (ASCO 2022)
    Background: The poly(ADP-ribose) polymerase inhibitors (PARPi) olaparib and rucaparib have been approved for the treatment of metastatic castration resistant prostate cancer (mCRPC) in the setting of homologous recombination deficiency (HRD)... The PARPi olaparib and talazoparib, and to a lesser extent veliparib, inhibited CRPC cell growth... We describe a novel sequela of PARPi therapy to alter AR localization and activity in CRPC. Single agent PARP inhibition can alter prostate cancer cell growth in vitro and in vivo. With PARPi treatment, AR localization is shifted to the cytoplasm, the AR interactome is altered, and AR transcriptional activity decreased.
    PARP Biomarker
    |
    AR (Androgen receptor) • HRD (Homologous Recombination Deficiency)
    |
    HRD
    |
    Lynparza (olaparib) • Talzenna (talazoparib) • Rubraca (rucaparib) • veliparib (ABT-888)
    2years
    Phase 3 ENABLAR-2 study to evaluate enobosarm and abemaciclib combination compared to estrogen-blocking agent for the second-line treatment of AR+, ER+, HER2- metastatic breast cancer in patients who previously received palbociclib and estrogen-blocking agent combination therapy. (ASCO 2022)
    The planned sample size is 186 patients randomized 1:1 to enobosarm + abemaciclib OR fulvestrant if the first line of therapy for MBC was a non-steroidal AI plus palbociclib, until disease progression, toxicity, or loss of clinical benefit. The key objectives are to determine the safety and efficacy of enobosarm and abemaciclib combination versus an alternative estrogen blocking agent with the primary endpoint of PFS. Secondary endpoints include ORR, duration of response, overall survival, change from baseline in Short Physical Performance Battery (SPPB), change in EORTC Quality of Life Questionnaire (EORTC-QLQ) and change in body composition as measured by DEXA.
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • AR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • fulvestrant • Ostarine (enobosarm)
    2years
    Androgen receptor modulation and bladder cancer prevention - a short review. (PubMed, Med Pr)
    Med Pr. 2022;73(2).
    Review • Journal
    |
    AR (Androgen receptor)
    2years
    VERU-024: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    2years
    Derivatives of betulinic acid act as modulators of the androgen receptor and report cytotoxicity towards cancer cell lines (AACR 2022)
    There could be not only AR modulation responsible for anticancer activity as the derivatives of betulinic acid are well know disruptors of mitochondrion functions as well. The synergy of these two mechanisms of action could potentiate the antitumor activity of the selected compounds.This work was supported by ENOCH CZ.02.1.01/0.0/0.0/16_019/0000868, CZ-OPENSCREEN - LM2018130, EATRIS-CZ - LM2018133.
    Preclinical
    |
    AR (Androgen receptor)
    over2years
    ARTEST - A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Enobosarm Monotherapy Versus Active Control for the Treatment of AR+/ER+/HER2- Metastatic Breast Cancer in Patients with Androgen Receptor Nuclei Staining ≥40% Who Have Shown Previous Disease Progression on a Nonsteroidal Aromatase Inhibitor, Fulvestrant and CDK 4/6 inhibitor ARTEST - Estudio aleatorizado de fase III para evaluar la eficacia y la seguridad del enobosarm en monoterapia frente a un control activo para el tratamiento del cáncer de mama metastásico RA+/RE+/HER2- en pacientes con tinción nuclear del receptor de andrógenos ≥40 % que han presentado una progresión previa de la enfermedad con un con un inhibidor de la aromatasa no esteroideo, fulvestrant y un inhibidor de CDK4/6. (clinicaltrialsregister.eu)
    P3, N=210, Ongoing, Veru Inc.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    everolimus • tamoxifen • fulvestrant • exemestane • Ostarine (enobosarm)
    over2years
    VERU-024: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Not yet recruiting, Veru Inc. | Phase classification: P2 --> P3
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)