EUCTR2016-003998-17-BE进行中（未招募）1 期
A phase Ib/II study of Durvalumab (MEDI4736) combined with dose-dense EC in a neoadjuvant setting for patients with locally advanced luminal B HER2(-) or triple negative breast cancers (B-IMMUNE)
Grand Hôpital de Charleroi0 个研究点目标入组 57 人开始时间: 2016年12月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
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.Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2.Female aged > 18 years at time of study entry.
- •3.Patient has T1, N1 or T2-T3 any N, M0, operable breast cancer
- •4.Confirmed invasive ductal, lobular, mixed or medullary breast carcinoma
- •5.TNBC defined as negative oestrogen and progesterone receptors as per local laboratory testing and negative HER2 defined as negative ISH test or and IHC status of 0 or 1+ as per local laboratory testing
- •6.Luminal B HER2 negative BC defined as positive oestrogen and/or progesterone receptors, a negative HER2 defined as negative ISH test or and IHC status of 0 or 1+ as per local laboratory testing and a Ki67 > 14%.
- •7.World Health Organisation (WHO) performance status of 0 or 1
- •8.Adequate normal organ and marrow function as defined below:
- •a.Haemoglobin = 9.0 g/dL
- •b.Absolute neutrophil count (ANC) = 1.5 x 109/L (> 1500 per mm3)
- •c.Platelet count = 100 x 109/L (>100,000 per mm3)
- •d.Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or
- •recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology).
- •AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit
- •Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- •creatinine CL (mL/min)=(Weight (kg) ×(140 – Age))/( 72 × serum creatinine (mg/dL))×0.85
- •9.Subjects must either be postmenopausal or must have a negative serum pregnancy test upon study entry. Women will be considered postmenopausal if they are:
- •a.post-menopausal by history: = 60 years old and no menses for ?1 year without an alternative medical cause
- •b.OR history of hysterectomy
- •c.OR history of bilateral tubal ligation
- •d.OR history of bilateral oophorectomy
- •10.Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including 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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •2.Previous enrolment in the present study
- •3.Participation in another clinical study with an investigational product during the last 4 weeks
- •4.Patient has locally recurrent or metastatic BC
- •5.Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease
- •6.History of another primary malignancy except for:
- •a.Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study drug and of low potential risk for recurrence
- •b.Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •c.Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ
- •7.Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) = 21 days prior to the first dose of study drug
- •8.Any previous treatment with a PD1 or PD-L1 inhibitor, including Durvalumab
- •9.Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- •10.Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- •11.Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia’s Correction
- •12.Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- •13.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
- •14.History of primary immunodeficiency
- •15.History of allogeneic organ transplant
- •16.History of hypersensitivity to Durvalumab or any excipient
- •17.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- •18.Subjects with uncontrolled seizures.
- •19.Known history of active tuberculosis
- •20.Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving Durvalumab
- •21.Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control
- •22.Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
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