EUCTR2016-004513-27-ES进行中（未招募）1 期
A phase II study of pembrolizumab and eribulin in patients with HR-positive/HER2-negative metastatic breast cancer previously treated with anthracyclines and taxanes - KELLY study (KEytruda and EribuLin in Luminal breast cancer)
Medica Scientia Innovation Research (MedSIR)0 个研究点目标入组 44 人开始时间: 2017年7月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Written informed consent prior to beginning specific protocol procedures.
- •2. Female patients = 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 which the Investigator believes is stable at the time of screening.
- •4. Life expectancy = 12 weeks.
- •5. Patients have a histologically and/or cytologically confirmeddiagnosis of breast cancer.
- •6. Patients have radiologic evidence of inoperable locally recurrent or MBC.
- •7. Patients have HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization (ISH) test or an immunohistochemistry (IHC) status of 0, 1+, or 2+ (if IHC 2+, a negative ISH test is required) by local laboratory testing.
- •8. Patients have HR-positive breast cancer defined as estrogen receptor (ER) and/or progesterone receptor (PR) with >1% of tumor cells positive for ER and/or PR by IHC irrespective of staining intensity.
- •9. Available tumor tissue for PD-L1 biomarker analysis from a newly obtained core or excisional biopsy since last progression of a metastatic tumor lesion not previously irradiated.
- •Note: Subjects for whom tumor biopsies cannot be obtained (e.g., inaccessible tumor or subject safety concern) may submit an archived metastatic tumor specimen only upon agreement from the Sponsor.
- •10. Patients have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 as assessed by site Investigator and local radiology review.
- •11. Patients have received at least one, but not more than two, prior chemotherapeutic regimens for locally recurrent and/or metastatic disease. Prior therapy must have included an anthracycline and a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient. Prior anti-hormonal therapy is mandatory.
- •12. Patients have adequate bone marrow and organ function as defined by the following laboratory values:
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L.
- •- Platelets = 100 x 109/L.
- •- Hemoglobin = 9 g/dL.
- •- Potassium, calcium (corrected for serum albumin), and magnesium within normal limits for the institution.
- •Serum creatinine = 1.5 x upper limit of normal (ULN).
- •- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) = 2.5 x ULN (or = 5.0 x ULN if liver metastases are present).
- •- Total serum bilirubin within normal range (or = 1.5 x ULN if liver metastases are present). Patients with known Gilbert disease who have serum bilirubin = 3 x ULN may be enrolled.
- •13. Patients must be accessible for treatment and follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1. Patients have received previous treatment with eribulin and an/or anti-PD1 or anti-PD-L1 agents.
- •2. Patients have a known hypersensitivity to any of the excipients of MK3475 (pembrolizumab) or eribulin.
- •3. Patients who have received chemotherapy, targeted small molecule therapy, or radiotherapy within two weeks of first dose of study treatment.
- •4. Patients who have received monoclonal antibodies for direct antineoplastic treatment or an investigational agent/device within four weeks of first dose of study treatment.
- •5. Patients have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Note: Known brain metastases are considered active, if any of the following criteria is applicable:
- •a. Brain imaging during screening demonstrates progression of existing metastases and/or appearance of new lesions compared to brain imaging performed at least four weeks earlier.
- •b. Neurological symptoms attributed to brain metastases have not returned to baseline.
- •c. Steroids were used for brain metastases within 28 days of first dose of study treatment.
- •6. Patients have peripheral neuropathy grade 2 or more.
- •7. Patients have a concurrent malignancy or malignancy within five years of study enrollment (with the exception of adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer).
- •8. Patients have not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy.
- •9. Patients have had a major surgical procedure within 28 days prior to starting study drug.
- •10. Patients have an active cardiac disease or a history of cardiac dysfunction including any of the following:
- •- Unstable angina pectoris or documented myocardial infarction within six months prior to study entry.
- •- Symptomatic pericarditis.
- •- History of documented congestive heart failure (New York Heart Association functional classification III-IV).
- •- Patients have a left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
- •11. Patients have any of the following cardiac conduction abnormalities:
- •- Ventricular arrhythmias except for benign premature ventricular contractions.
- •- Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication.
- •- Conduction abnormality requiring a pacemaker.
- •- Other cardiac arrhythmia not controlled with medication.
- •12. Uncontrolled hyper/hypothyroidism or type 1 diabetes mellitus (T1DM). Patients with hypothyroidism stable on hormone replacement will not be excluded from the trial. Patients with controlled T1DM on a stable insulin regimen may be eligible for this study.
- •13. Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that has required systemic treatment (steroids or immunosuppressiveagents) in the past two years.
- •14. Prior allogenic stem cell or solid organ transplantation.
- •15. Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease.
- •16. Active uncontrolled infection at the time of screening
- •17. Active tuberculosis.
- •18. Current known infection with HIV.
- •19. Active hepatitis B (HBV) [patients with negative hepatitis B surface antigen (HBsAg) test and a positive antibody to HBsAg (anti-HBsAg) test at screening are eligible] or hepatitis C (HCV) [patients with a positive antibody to hepatitis C (anti-HCV) are eligible only if polymerase chain reactio
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