Clinical trial · Interventional
Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer Patients: An Open-Labeled, Single-center, Prospective Study
NCT05206656CI-TRIAL-00062332completedPhase 2ClinicalTrials.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)
Eribulin is the promising agent for late-line metastatic breast cancer patients. The aim of this Phase II, double-arm, open-label and prospective clinical trial is to assess the efficacy and safety of Eribullin or Eribulin combined with Anlotinib in patients with metastatic 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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Eribulin Mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Eribulin mesylate
- description
- Metastatic breast cancer patients receive eribulin mesylate injection alone. The dosage is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Patients receive Eribulin untill progression. Patients were observed for at least 6 months but no longer than 18 months.
- interventionNames
- Drug: Eribulin Mesylate
- type
- EXPERIMENTAL
- label
- Eribulin mesylate combined with Anlotinib
- description
- Metastatic breast cancer patients receive Eribulin mesylate combined with Anlotinib. The dosage of Eribulin mesylate is 1.4mg/m2 for one cycle. Injection is performed on Day 1 and Day 8 of a treatment cycle. Anlotinib dosage is 12mg per day for consecutive 14 days (21 days per cycle). Patients receive Anlotinib untill progression. Patients were observed for at least 6 months but no longer than 18 months.
- interventionNames
- Drug: Eribulin Mesylate
- Drug: Anlotinib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old, voluntary consent and signed written informed consent * ECOG 0\~2 * Pathologically diagnosed HER2-negative breast cancer patients with radiologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer; HR-positive patients were permitted * At least one measurable disease lesion before treatment * Never receive Eribulin Mesylate treatment or anti-angiogenetic therapies before recruitment * Anticipated survival time is longer than three months * Brain metastases with stable disease or without clinical symptom * Blood routine test, liver and kidney function test meet the following criteria: PLT \> 100g / L, Hb \> 9g / L, Neutrophil \> 2.0 g/L; AST and ALT \< 2.5 upper limit of normal (ULN); Cr \< 1.0 ULN; TBIL \< 1.5ULN * Previously treated with anthracycline-based and taxane-based chemotherapy regimens (at least one line of chemotherapy in the metastatic setting or the recurrence time is less than 1 year from the end of adjuvant or neoadjuvant chemotherapy); for HR-positive/HER2-negative patients, progressed after at least one line of endocrine therapy * For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment; Men agreed to take appropriate contraceptive measures during the study treatment and at least half a year after the end of the treatment. Exclusion Criteria: * Pregnant or lactating women * Active infection requiring systemic treatment * HIV positive * Suffering from or suspected of suffering from central neuromuscular system diseases * Serious heart disease; uncontrollable hypertension; history of heavy hemorrhea;recent operation within three months * The investigator considered that the patient was not suitable for in this study, with any other situation.
References
Publications (0)
Data not yet available
No reference posted for this study.