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NCT01463891
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
trial testing Eribulin Mesylate in Inoperable or Recurrent Breast Cancer in 963 participants. Completed in 27 November 2013.
26 December 2012
Quick facts
| Lead sponsor | Eisai Co., Ltd. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 963 |
| Start date | 19 July 2011 |
| Primary completion | 26 December 2012 |
| Estimated completion | 27 November 2013 |
| Sites | 223 locations across Japan |
Drugs / interventions tested
- Eribulin Mesylate — full drug profile →
Conditions studied
- Inoperable or Recurrent Breast Cancer — all drugs for Inoperable or Recurrent Breast Cancer →
Sponsor
Eisai Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Inoperable or Recurrent Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study.
Watanabe J, Ito Y, Ohsumi S, Mizutani M, et al · · 2017 · cited 15× · PMID 28660549 · DOI 10.1007/s10637-017-0486-4 -
Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study.
Sakata Y, Matsuoka T, Ohashi S, Koga T, et al · · 2019 · cited 6× · PMID 30847841 · DOI 10.1007/s40801-019-0150-8 -
Incidence and relative risk of peripheral neuropathy in cancer patients treated with eribulin: a meta-analysis.
Peng L, Hong Y, Ye X, Shi P, et al · · 2017 · cited 6× · PMID 29340112 · DOI 10.18632/oncotarget.21057
Verify or expand the search:
- PubMed search for NCT01463891
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eribulin Mesylate
Trials testing the same drug.
- NCT06590558 — Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Er · Phase 1 · withdrawn
- NCT05041101 — Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer · Phase 1, PHASE2 · terminated
- NCT04579224 — Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothel · Phase 3 · active not recruiting
- NCT04345913 — Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer · Phase 1, PHASE2 · active not recruiting
- NCT05206656 — Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer · Phase 2 · completed
Other Eisai Co., Ltd. trials
Trials by the same sponsor.
- NCT07515014 — A Study of E6742 in Participants With Systemic Lupus Erythematosus · Phase 2 · not yet recruiting
- NCT06793709 — A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast G · recruiting
- NCT06657378 — A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized T · recruiting
- NCT06322667 — A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab · recruiting
- NCT05633108 — A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders · completed
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 NCT01463891 (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 Eisai Co., Ltd.
- Last refreshed: 24 July 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/NCT01463891.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing