A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib f… (NCT07520760) | Clinical Trial Compass
RecruitingPhase 2
A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates
China52 participantsStarted 2026-04-01
Plain-language summary
This study is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer. Participants in this study have already tried other treatments like T-DXd or SG, but their cancer has gotten worse, and there are currently no standard treatment options left for them. Researchers believe that using these two drugs together may work better than using either one alone based on how they target cancer cells. The goal is to offer a new choice and help improve survival for these patients.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female patients aged ≥ 18 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
✓. HER2-negative status, defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with negative HER2 gene amplification by fluorescence in situ hybridization (FISH). If multiple specimens have been tested, the most recent test result will be used for determination.
✓. Prior treatment with anthracycline- or taxane-containing chemotherapy, including in the neoadjuvant or adjuvant setting.
✓. Intolerance or disease progression following prior treatment with an antibody-drug conjugate (ADC), without the initiation of a new treatment regimen after ADC therapy.
✓. Received no more than 4 prior lines (including 4 lines) of chemotherapy.
✓. At least one measurable lesion per RECIST v1.1.
✓. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
✓. Life expectancy ≥ 12 weeks.
Exclusion criteria
What they're measuring
1
Progression free survival
Timeframe: From date of first dose until the date of first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 24 months
✕. Untreated active brain metastases. Patients with asymptomatic central nervous system (CNS) metastases or those with stable brain metastases following radiotherapy are eligible.
✕. Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, except for patients who have been stable for at least 1 month after treatment and have discontinued corticosteroids for \> 2 weeks.
✕. HER2-positive status, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with positive HER2 gene amplification by fluorescence in situ hybridization (FISH). Patients with a prior HER2-positive status but who are HER2-negative per the most recent pathology test are eligible.
✕. History of clinically significant cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric diseases.
✕. Acute or chronic active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] positive and/or hepatitis B core antibody \[HBcAb\] positive with hepatitis B virus \[HBV\] DNA copy number ≥ 1 × 10³ copies/mL or ≥ 200 IU/mL) or acute or chronic active hepatitis C (hepatitis C virus \[HCV\] antibody positive). Patients with positive HCV antibody but negative HCV RNA are eligible.
✕. Receipt of anti-tumor monoclonal antibody therapy within 4 weeks prior to study initiation, or prior treatment with other anti-tumor therapies with unresolved adverse events/reactions.
✕. Known inherited or acquired bleeding tendencies (e.g., hemophilia, coagulation disorders, etc.).
✕. History or evidence of any disease, condition, treatment, or laboratory abnormality that may interfere with the study results or preclude the patient's full participation in the study, or any other condition deemed unsuitable for enrollment by the investigator.