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NCT05079360
Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer
Phase 2 trial testing Sabizabulin in Metastatic Breast Cancer. Withdrawn.
30 March 2024
Quick facts
| Lead sponsor | Veru Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 15 March 2023 |
| Primary completion | 30 March 2024 |
| Estimated completion | 26 May 2024 |
| Sites | 26 locations across United States |
Drugs / interventions tested
- Sabizabulin — full drug profile →
- Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator — 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 sabizabulin in the treatment of ER+HER2- metastatic breast cancer (MBC) as measured by progression free survival (PFS) by RECIST v1.1.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Sabizabulin, a Potent Orally Bioavailable Colchicine Binding Site Agent, Suppresses HER2+ Breast Cancer and Metastasis.
Krutilina RI, Hartman KL, Oluwalana D, Playa HC, et al · · 2022 · cited 20× · PMID 36358755 · DOI 10.3390/cancers14215336
Verify or expand the search:
- PubMed search for NCT05079360
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sabizabulin
Trials testing the same drug.
- NCT05008510 — P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC . · Phase 2 · withdrawn
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
- 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
- NCT04869943 — Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer · Phase 3 · terminated
- 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)
- Trial protocol + status: ClinicalTrials.gov NCT05079360 (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: 24 March 2023
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/NCT05079360.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing