CTRI/2009/091/000660暂停3 期
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 cancerAcronym : STRIDE
Merck KGaA, Frankfurter Str. 25,064293 Darmstadt, Germany0 个研究点目标入组 909 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 909
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Postmenopausal women
- •2. ER+ and/or PgR+, histologically or cytologically confirmed primary carcinoma of the breast
- •3. 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
- •4. Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least one lesion not located in bone).
- •5. Measurable disease by RECIST, and inoperable
- •6. ECOG performance status of 0 or 1
- •7. Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy, as defined by the protocol
排除标准
- •Disease Status
- •1. PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 12 months of completing such therapy
- •2.Human epidermal growth factor receptor 2-positive (HER2+) breast cancer
- •3. 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.)
- •4. Recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies
- •5. 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
- •1.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 (28 days) prior to randomization. Note: Subjects who have received monoclonal antibodies for imaging are eligible.
- •2. 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.
- •Physiological Function
- •3. Central nervous system disease or brain metastases, as documented by computed tomography (CT) or magnetic resonance imaging (MRI)
- •4. Splenectomy
- •Standard Criteria
- •1. Need for concurrent treatment with a non-permitted therapy (e.g., concurrent chemotherapy, radiotherapy, systemic immunosuppressive drugs, use of herbal medicines or botanical formulations intended to treat cancer) while on protocol therapy. Palliative radiation to painful bone lesions is allowed.
研究者
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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 cancer1003860810006232breast cancerNL-OMON33179Merck25
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进行中（未招募）
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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）
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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-IEMerck KGaA1,200