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NCT04869943: ARTEST
Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer
Terminated
Phase 3
Last updated 26 January 2024
What this trial tests
Phase 3 trial testing Enobosarm in Metastatic Breast Cancer in 52 participants. Terminated before completion.
Timeline
12 October 2021
Primary endpoint
9 January 2024
9 January 2024
9 January 2024
Quick facts
| Lead sponsor | Veru Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 12 October 2021 |
| Primary completion | 9 January 2024 |
| Estimated completion | 9 January 2024 |
| Sites | 54 locations across Spain, Ukraine, United States, Poland |
Drugs / interventions tested
- Enobosarm — full drug profile →
- Exemestane (exemestane) — full drug profile →
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
Veru Inc. — full company profile →
Who can join
Adults 18 to 100, any sex, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Androgen receptor function and targeted therapeutics across breast cancer subtypes.
Kolyvas EA, Caldas C, Kelly K, Ahmad SS. · · 2022 · cited 59× · PMID 36376977 · DOI 10.1186/s13058-022-01574-4 -
CDK4/6 inhibitor resistance in estrogen receptor positive breast cancer, a 2023 perspective.
Zhou FH, Downton T, Freelander A, Hurwitz J, et al · · 2023 · cited 42× · PMID 37035239 · DOI 10.3389/fcell.2023.1148792 -
Emerging systemic therapy options beyond CDK4/6 inhibitors for hormone receptor-positive HER2-negative advanced breast cancer.
Ma J, Chan JJ, Toh CH, Yap YS. · · 2023 · cited 38× · PMID 37684290 · DOI 10.1038/s41523-023-00578-3 -
Revisiting Androgen Receptor Signaling in Breast Cancer.
Dai C, Ellisen LW. · · 2023 · cited 26× · PMID 36972361 · DOI 10.1093/oncolo/oyad049 -
Modulating the Activity of Androgen Receptor for Treating Breast Cancer.
You CP, Tsoi H, Man EPS, Leung MH, et al · · 2022 · cited 18× · PMID 36499670 · DOI 10.3390/ijms232315342 -
Novel Treatment Strategies for Hormone Receptor (HR)-Positive, HER2-Negative Metastatic Breast Cancer.
Ferro A, Campora M, Caldara A, De Lisi D, et al · · 2024 · cited 14× · PMID 38930141 · DOI 10.3390/jcm13123611 -
Type 1 Nuclear Receptor Activity in Breast Cancer: Translating Preclinical Insights to the Clinic.
Kumar S, Freelander A, Lim E. · · 2021 · cited 13× · PMID 34638457 · DOI 10.3390/cancers13194972 -
Improving efficacy of TNBC immunotherapy: based on analysis and subtyping of immune microenvironment.
Yang Y, Li H, Yang W, Shi Y. · · 2024 · cited 11× · PMID 39430759 · DOI 10.3389/fimmu.2024.1441667
Verify or expand the search:
- PubMed search for NCT04869943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Enobosarm
Trials testing the same drug.
- NCT06282458 — Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt · Phase 2 · completed
- NCT02971761 — Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cance · Phase 2 · completed
Other recruiting trials for Metastatic Breast Cancer
Currently open trials in the same condition.
- NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
- NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
Other Veru Inc. trials
Trials by the same sponsor.
- NCT06282458 — Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt · Phase 2 · completed
- NCT05079360 — Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer · Phase 2 · withdrawn
- NCT05065411 — Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer · Phase 3 · terminated
- NCT05008510 — P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC . · Phase 2 · withdrawn
- NCT04844749 — Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04869943 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Veru Inc.
- Last refreshed: 26 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04869943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing