EUCTR2008-005544-17-SE进行中（未招募）不适用
A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer STRIDE - STimulating immune Response In aDvanced brEast cancer - STRIDE
MMerck KGaA0 个研究点目标入组 1,200 人开始时间: 2009年7月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
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
- •For inclusion in the study, all of the following inclusion criteria must be fulfilled:
- •Written informed consent given before any study-related activities are carried out
- •Female inpatient or outpatient
- •= 18 years of age
- •Postmenopausal, defined by at least one (1) of the following:
- •* No spontaneous menses for at least five years
- •* Spontaneous menses within the past five years but amenorrheic for at least 12 months and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) within the postmenopausal normal range (Subjects who are amenorrheic following a hysterectomy but who have not had bilateral salpingo-oophorectomy are not eligible unless they have additional biochemical evidence of menopause as reflected by ovarian suppression and FSH and plasma estradiol levels in the postmenopausal range.)
- •* Prior bilateral oophorectomy
- •* Prior bilateral ovarian irradiation and castration, amenorrheic for at least three months, and FSH levels > 40 IU/L
- •* No menstrual period for 12 months or longer and a serum estradiol level in the postmenopausal range (= 22 pg/mL)
- •ER+ and/or PgR+, histologically or cytologically confirmed primary carcinoma of the breast (institutional pathological diagnosis of BRCA is acceptable)
- •Expressing at least one of the following five HLA haplotypes, as centrally assessed by HLA genotyping from whole blood: HLA-A2, -A3, -A11, -B7, or -B35
- •Locally advanced, recurrent, or metastatic BRCA (Subject must have at least one lesion not located in bone).
- •Measurable disease by RECIST, and inoperable (not eligible for breast-conserving surgery or mastectomy) with no reasonable expectation of surgery for cure now or in the future.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of at least 12 weeks
- •Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy, as defined by the following:
- •* White blood cells (WBCs) = 2500/mm3; absolute neutrophils = 1500/mm3; platelets = 100,000/mm3
- •* Hemoglobin = 9 g/dL
- •* Bilirubin = 1.5 × the upper limit of normal (ULN), or = 5 × ULN in case of hepatic metastasis
- •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN, or = 5 × ULN in case of hepatic metastasis
- •* Creatinine = 1.5 × ULN
- •* International Normalized Ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT) in the normal range
- •Willingness to comply with study protocol requirements
- •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
- •Subjects are not eligible for this study, if they fulfill one or more of the following exclusion criteria:
- •Disease Status
- •PD either during HT for early breast cancer (adjuvant therapy) or within 12 months of completing such therapy
- •Human epidermal growth factor receptor 2-positive (HER2+) BRCA, defined as follows:
- •* Immunohistochemistry (IHC) staining of 3+ (uniform, intense membrane staining of > 30% of invasive tumor cells), or
- •* Fluorescent in situ hybridization (FISH) result > 6 HER2 gene copies per nucleus, or
- •* FISH ratio (HER2 gene signals to chromosome 17 signals) > 2.2.
- •Historical data will routinely be confirmed by local pathology laboratories in case of equivocal” historical results as follows:
- •o By validated FISH-test if HER2 protein expression is equivocal (i.e., IHC 2+) or, if appropriate
- •o By validated IHC if HER2 gene amplification is equivocal” (i.e., FISH ratio 1.8-2.2 or HER2 gene copy 4.0-6.0)
- •Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study. (Exception will be granted for well-controlled Type I diabetes mellitus.)
- •Recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies
- •Known active hepatitis B infection or carrier state and/or hepatitis C infection, known human immunodeficiency virus (HIV) infection, or any other infectious process that in the opinion of the investigator could compromise the subject’s ability to mount an immune response, or could expose her to the likelihood of more and/or severe side effects
- •Past or current history of malignant neoplasm other than BRCA, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least five years Pre-therapies
- •Receipt of immunotherapy (e.g., interferons; tumor necrosis factor; interleukins; growth factors granulocyte macrophage-colony stimulating factor [GM-CSF], granulocyte-colony stimulating factor [G-CSF], macrophage-colony stimulating factor [M-CSF], or monoclonal antibodies), or chemotherapy, within four weeks (28days) prior to randomization. Note: Subjects who have received monoclonal antibodies for imaging are eligible.
- •Prior receipt of investigational systemic drugs (including off-label use of approved products) or any kind of systemic treatment (chemotherapy, HT, or immunotherapy) for inoperable, locally advanced, recurrent, or metastatic breast cancer
- •Prior radiotherapy to the site of cancer, if only one site will be used for evaluation of tumor response. Prior use of bisphosphonates or concurrent use while on study treatment is allowed.
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