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（MBC-EA-II-01）
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
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.
详细描述
This is an exploratory study designed to evaluate the efficacy of eribulin in combination with anlotinib in patients with HER2-negative recurrent or metastatic breast cancer who have experienced treatment failure with antibody-drug conjugates (ADCs). The study aims to assess the efficacy and safety of eribulin combined with anlotinib in the treatment of patients with recurrent or metastatic HER2-low breast cancer, and to provide clinical evidence supporting this novel combination regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •Life expectancy ≥ 12 weeks.
- •Adequate major organ function as defined by the following criteria:
- •Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 75 × 10⁹/L, hemoglobin (Hb) ≥ 85 g/L (without transfusion or blood product support, or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening).
- •Biochemistry: Total bilirubin (TBIL) < 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1 × ULN, or calculated creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula).
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must agree to use adequate contraception during the study period and for 8 weeks after the last dose of study treatment. Women not of childbearing potential (i.e., surgically sterile or postmenopausal for at least 1 year) are eligible without requiring contraception.
- •Willing and able to provide written informed consent, with good compliance and willingness to complete scheduled follow-up.
排除标准
- •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.
- •Any severe underlying disease, comorbidity, or active infection.
- •Concurrent receipt of other anti-tumor therapy.
- •History of epilepsy or conditions predisposing to seizure.
- •Pregnant or breastfeeding women.
- •Poor compliance or inability to complete scheduled follow-up.
- •Known hypersensitivity to the study drugs.
- •Diagnosis of another malignancy within 3 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, locally curative prostate cancer, surgically resected ductal carcinoma in situ, or malignancies diagnosed > 2 years prior to enrollment with no evidence of disease and no treatment within ≤ 2 years before randomization.
- •Any other condition that, in the investigator's judgment, may affect the conduct of the study or the interpretation of study results.
研究组 & 干预措施
TNBC and HR positive cohorts
干预措施: Eribulin in Combination with Anlotinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: 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
Progression free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first. For patients who have not experienced disease progression or death at the time of analysis, PFS will be censored at the date of the last adequate tumor assessment. If no post-baseline tumor assessment is available, PFS will be censored at the date of first dose. Disease progression is determined by investigator assessment based on imaging evaluations (e.g., CT, MRI) performed at baseline and at scheduled time points throughout the study. Unit of Measure: Months
次要结局
- Overall survival(From date of first dose until death from any cause, assessed up to 36 months)
- Safety(From date of informed consent through 30 days after last dose of study treatment)
- Quality of Life (QoL)(From baseline to end of study follow-up, assessed up to 24 months)
研究者
Jia-Jia Huang
Department of Medical Oncology Professor, Principal Investigator, Chief Physician
Sun Yat-sen University