EUCTR2017-001428-23-NL进行中（未招募）1 期
AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trial
KI-AV0 个研究点目标入组 40 人开始时间: 2017年6月15日最近更新:
适应症
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
- 40
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
入选标准
- •Signed and written informed consent
- •Age 18 year or older
- •Metastatic or incurable locally advanced lobular breast cancer with confirmation of the lobular histology and E-cadherin loss or aberrant staining (IHC) on a biopsy of a metastatic lesion. For patients with a tumor with a mixed-type IDC/ILC or IDC with lobular features a loss or aberrant expression of E-cadherin (IHC) is required
- •Estrogen receptor expression of at least 10% on a metastatic lesion (independent of progesterone receptor expression and HER2 expression)
- •Metastatic lesion accessible for histological biopsies (Mandatory biopsies: pre-induction treatment with carboplatin, before start atezolizumab, after 2 cycles of atezolizumab. Optional: upon development of acquired resistance). Biopsies from bone lesions are not permitted. Interval between last chemotherapy and pre-induction biopsy has to be at least 14 days (not for endocrine treatment in view of the relatively long half-life). The pre-induction treatment biopsy has to contain sufficient tumor content (=100 tumor cells); subjects with samples that have insufficient tumor content will require re-biopsy prior to start carboplatin.
- •Evidence of progression of disease (either radiological or clinical)
- •Disease progression had to occur after previous endocrine (not necessarily the most recent) therapy in the advanced setting. Patients with an ER-positive tumor must have received an anti-estrogen (tamoxifen and/or fulvestrant) and at least one aromatase inhibitor for early breast cancer or metastatic disease.
- •A maximum of two lines of palliative chemotherapy for metastatic or incurable locally advanced breast cancer is allowed. HER2-targeting therapy is allowed for the HER2-positive cases.
- •WHO performance status of 0 or 1
- •Evaluable disease or measurable according to RECIST 1.1
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •known leptomeningeal disease localization
- •history of having received other anticancer therapies within 2 weeks of start of the study drug
- •history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mg/day prednisone or equivalent) or chronic infections. Subjects with vitiligo, diabetes mellitus type I, psoriasis not requiring systemic treatment or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement, Sjøgren’s syndrome or conditions not expected to recur in the absence of an external trigger will not be excluded from the study. Adrenal replacement doses >10 mg/day prednisone or equivalent are permitted in the absence of active autoimmune disease
- •prior treatment with immune checkpoint blockade such as but not limited to anti-PD(L)1, anti-PD-L2, anti-CTLA-4, anti-GITR or CD137/OX40-agonist
- •live vaccine within 2 weeks prior to start of study, at any time during the study, or within 5 months following the last dose of atezolizumab. Inactivated vaccines are allowed
- •active other cancer
- •active hepatitis B (defined as having a positive hepatitis B surface antigen [HbsAg] test at screening) or active hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNActive tuberculosis
研究者
相似试验
已完成
2 期
AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trialNL-OMON48948ederlands Kanker Instituut40
已完成
2 期
EJ043on-sequamous non-small cell lung cancerJPRN-jRCTs031190066Kikuchi Toshiaki60
进行中（未招募）
2 期
OGIK2002(RESTART)Treatment-naive advanced non-squamous non-small cell lung cancerNSCLC, advanced, renal dysfunctionD002289JPRN-jRCTs071200102Okamoto Isamu25
进行中（未招募）
2 期
A phase 2 study of atezolizumab with carboplatin plus pemetrexed followed by maintenance atezolizumab with pemetrexed for elderly patients with advanced non-squamous non-small cell lung canceron-squamous non-small cell lung cancerJPRN-jRCTs041200032Itani Hidetoshi60
终止
2 期
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast CancerBreast CancerNCT03147040The Netherlands Cancer Institute23