Clinical trial · Interventional
Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer
A Multicenter, Phase II, Open-label, Single-arm Investigator Initiated Trial to Evaluate the Efficacy and Safety of Eribulin Mesylate Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer Patients
NCT04624711CI-TRIAL-00051935unknownPhase 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)
This is a multicenter, phase II, open-label, single-arm investigator initiated trial to evaluate the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients.
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 |
|---|---|---|---|
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib hydrochloride | Drug | — | UNRESOLVED |
| Eribulin Mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eribulin Mesylate Combined With Anlotinib
- description
- Patients receive eribulin mesylate plus anlotinib.
- interventionNames
- Drug: Eribulin Mesylate
- Drug: Anlotinib hydrochloride
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 2 year
- description
- Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * The patient volunteers and signs an informed consent form; * Age ≥18 years old, female; * The patient was diagnosed as HER2 negative breast cancer by histopathology ( HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is at least 1 measurable lesion of metastasis according to RECIST 1.1; * All patients have previously underwent chemotherapy containing anthracyclines and taxanes, and received ≥1 line chemotherapy for metastatic breast cancer; * Patients with hormone receptor positive (ER positive (IHC ER positive percentage ≥1%), PR positive (IHC PR positive percentage ≥1%)) have underwent ≥1 line endocrine therapy; * Physical condition ECOG PS: 0-1; * Laboratory tests meet the following criteria: 1. Bone marrow function: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥90g/L; 2. Liver function: serum total bilirubin (STB), combined bilirubin (CB) ≤ upper limit of normal (ULN) \*1.5; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN\*2.5; 3. Renal function: serum creatinine (Cr) ≤ ULN; endogenous creatinine clearance (Ccr) ≥ 60 ml / min (calculated using the Cockcroft-Gault formula). Exclusion Criteria: * Previous breast cancer history (except for ipsilateral DCIS that only received local treatment ≥5 years ago), malignant tumors of other histological origins (except for non-melanoma skin cancer or cervical carcinoma in situ) unless the patient's tumor had been completely alleviated and had not received treatment for at least 5 years before the enrollment date; * Major surgery within 4 weeks prior to enrollment, or surgical wounds have not healed; * Embolization and bleeding occurred within 4 weeks before enrollment; * Severe cardiovascular disease, including hypertension (BP≥160/95mmHg) uncontrolled by medical treatment, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure\>NYHA II, severe heart rhythm Abnormalities and pericardial effusions; * Severe infection requires intravenous antibiotic, antifungal or antiviral treatment; * Other clinical trials of drugs were used in the first four weeks of the first medication; * Subjects with treatment history of eribulin or anti-angiogenesis drugs; * Suffering from mental illness, poor compliance; * Researchers believe that it is not suitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.