EUCTR2008-005544-17-IT进行中（未招募）不适用
A randomized, double-blind, controlled phase III study of Stimuvax (L-BLP25 or BLP25 liposomevaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapyof post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locallyadvanced, recurrent, or metastatic breast cancer - STRIDE - STimulating immune Response In aDvanced brEast cancer
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
- 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
- •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
- •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 subjects 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.
研究者
相似试验
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 - STRIDEpost-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancerMedDRA version: 12.0Level: LLTClassification code 10055113Term: Breast cancer metastaticEUCTR2008-005544-17-SEMMerck KGaA1,200
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 - STRIDEpost-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancerMedDRA version: 9.1Level: PTClassification code 10055113Term: Breast cancer metastaticEUCTR2008-005544-17-CZMerck KGaA1,200
暂停
3 期
STRIDE - A Randomised, Double-Blind, Phase III Study of Stimuvax® in combination with Hormonal Treatment versus Hormonal Treatment alone for First-line Therapy of endocrine-sensitive Advanced Breast CancerCTRI/2009/091/000660Merck KGaA, Frankfurter Str. 25,064293 Darmstadt, Germany909
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 - STRIDEEUCTR2008-005544-17-SKMerck KGaA1,200
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 - STRIDEpost-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancerMedDRA version: 9.1Level: PTClassification code 10055113Term: Breast cancer metastaticEUCTR2008-005544-17-BEMerck KGaA1,200