EUCTR2008-001084-10-FR进行中（未招募）不适用
A multicenter phase II clinical trial assessing the efficacy of the combination of lapatinib and capecitabine in patients with non pretreated brain metastasis from HER2 positive breast cancer. - LANDSCAPE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- FNCLCC
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
- All
入选标准
- •1. Histologically confirmed invasive breast cancer with stage IV disease.
- •2. HER-2 positive primary tumor, defined as : IHC3+, or IHC2+ and FISH positive.
- •3. At least one measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI.
- •4. At least two weeks from any specific breast cancer treatment (such as Trastuzumab,
- •chemotherapy, immunotherapy/biological response modifiers, endocrine therapy and
- •radiotherapy).
- •5. Adequate hematologic function (ANC = 1.0x109/L, platelets = 100 000 ; Hb = 10g/l), renal
- •function (creatinine = 1.5 UNL) and hepatic function (albumin = 2.5 g/dL ;
- •serum bilirubin = 1.5x ULN unless due to Gilbert’s syndrome ; ASAT and ALAT = 5x ULN if
- •documented liver metastases or = 3x ULN without liver metastases)
- •6. Patients able to swallow and retain oral medication.
- •7. At least 18 years old.
- •8. ECOG Performance Status of 0 to 2.
- •9. Life expectancy = 3 months.
- •10. Potentially reproductive patients must agree to use an effective contraceptive method while
- •on treatment, beginning 2 weeks before the first dose of investigational product and for 28
- •days after the final dose of investigational product for women. Males able to father a child
- •must practice adequate methods of birth control or practice complete abstinence from
- •intercourse from the first dose of investigational treatment until one week after the final
- •dose of investigational treatment.
- •11. Women of childbearing potential must have a negative serum pregnancy test within 14
- •days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the
- •first study treatment.
- •12. Patients must be affiliated to a Social Security System.
- •13. Patient information and written informed consent form signed.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Previous whole brain radiotherapy (WBRT) or brain stereotactic radiotherapy.
- •2) Planned or concurrent systemic treatment or radiation therapy for breast cancer (other that
- •corticosteroid, biphosphonates or mannitol).
- •3) Single brain metastasis which could be treated by surgery.
- •4) Known contra-indication to MRI.
- •5) Active concurrent malignancy. If there is a history of prior malignancy, the patient must be
- •disease free for at least 10 years.
- •6) Previous treatment with capecitabine, and/or lapatinib.
- •7) Patients with other concurrent severe and/or uncontrolled medical disease which could
- •compromise participation in the study, such as :
- •a) infection,
- •b) cardiac disease such as uncontrolled hypertension, congestive cardiac failure,
- •ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one
- •year, LVEF > grade 2,
- •c) current active hepatic or biliary disease (with exception of subjects with Gilbert's
- •syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per
- •investigator assessment),
- •d) renal disease,
- •e) active GI tract ulceration, malabsorption syndrome, disease significantly affecting
- •gastrointestinal function, or resection of the stomach or small bowel. Subjects with
- •active, uncontrolled ulcerative colitis are also excluded,
- •f) severely impaired lung function (spirometry and DLCO 50% or less of normal and O2
- •saturation of 88% or less at rest on room air).
- •8) Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •9) Patients being treated with drugs recognized as being strong inhibitors or inducers of the
- •isoenzyme CYP3A (Clarithromycin, Ketoconazole, Itroconazole, Voriconazole, Ritonavir, etc.)within the last 7 to 14 days prior to inclusion and/or during the study.
- •10) Pregnant women, women who are likely to become pregnant or are breast-feeding.
- •11) Patients with significantly altered mental status prohibiting the understanding of the study or
- •with psychological, familial, sociological or geographical condition potentially hampering
- •compliance with the study protocol and follow-up schedule; those conditions should be
- •discussed with the patient before registration in the trial.
- •12) Patients who received any other investigational drugs within the 30 days prior to the
- •screening visit.
- •13) Individual deprived of liberty or placed under the authority of a tutor.
研究者
相似试验
未知
2 期
A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phaseChronic myelogenous leukemiaJPRN-UMIN000001927Tokyo STI Study Group50
招募中
不适用
A multicentre two-arm, phase II trial assessing the safety and efficacy of first-line lazertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancerNeoplasmsKCT0006760Yonsei University Health System, Severance Hospital68
已完成
不适用
Phase II Multicenter Clinical Trial to evaluate the immune response generation capacity and the safety of the ALVAC-HIVVCP1452 Vaccine administered alone and in combination with the MN rpg 120 / HIV-1 vaccine in humans from Brazil, Haiti, Peru and Trinidad and Tobago.-B23 Human immunodeficiency virus [HIV] disease resulting in other conditionsHuman immunodeficiency virus [HIV] disease resulting in other conditionsB23PER-036-01FRED HUTCHINSON CANCER RESEARCH CENTER,
进行中（未招募）
1 期
A clinical trial to evaluate the efficacy and safety ofpembrolizumab and gemcitabine in patients with HER2-negative Advanced Breast Cancer. PANGEA-Breast”Patients with HER2-negative advanced breast cancer.MedDRA version: 19.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2016-001779-54-ESGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)36
进行中（未招募）
1 期
Clinical Trial to study the effect of the treatment with eribulin and endocrine therapy in metastatic breast cancer patientsuminal Metastatic Breast CancerMedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864EUCTR2017-004324-30-ESMedica Scientia Innovation Research (MEDSIR)60