EUCTR2008-005544-17-SK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 locallyadvanced, recurrent, or metastatic breast cancerSTRIDE - STimulating immune Response In aDvanced brEast cancer - STRIDE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 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
- •?????? 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,
- •?????? 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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