Clinical trial · Observational
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer
NCT01463891CI-TRIAL-00068229completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inoperable or Recurrent Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin Mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Eribulin Mesylate
- interventionNames
- Drug: Eribulin Mesylate
Primary outcomes (1)
- measure
- Effectiveness Diagnosed by Imaging
- timeFrame
- 1 year
- description
- Effectiveness diagnosed by imaging, is based on Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Defined as: * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than10 mm. * Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. * Not Evaluable (NE).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria : * Inoperable breast cancer * Recurrent breast cancer Exclusion criteria : * Corresponding to contraindication of eribulin mesylate * Not applicable to indications of eribulin mesylate * Not applicable to aggravation or recurrence of breast cancer in patients who have previously been treated with anthracycline and/or taxane antitumor drugs
References
Publications (1)
- RESULTWatanabe J, Ito Y, Ohsumi S, Mizutani M, Tashiro H, Sakurai K, Takahashi M, Saito T, Tsurutani J, Mukai H, Yoshinami T, Takao S, Yamamoto Y, Matsuoka T, Iwase H, Iwata H, Nakamura S, Saeki T. Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study. Invest New Drugs. 2017 Dec;35(6):791-799. doi: 10.1007/s10637-017-0486-4. Epub 2017 Jun 29. PMID 28660549