NL-OMON33179已完成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 cancer - STRIDE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Merck
- 入组人数
- 25
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Female, inpatient or outpatient, 18 years of age or older, who are post-menopausal as defined by at least one 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 post-menopausal 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 post-menopausal range (<= 22 pg/mL)
- •ER- and/or PgR-positive, histologically or cytologically confirmed primary carcinoma of the breast (institutional pathological diagnosis of BRCA is acceptable).
- •Expressing at least one of the following five human leukocyte antigen (HLA) haplotypes as centrally assessed by HLA-genotyping: 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.
- •ECOG performance status of 0 or 1.
- •Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy as defined by the following:
- •- White blood cells >= 2,500/mm3, absolute neutrophils >= 1,500/mm3 and platelets >= 100,000/mm3
- •- Hemoglobin >= 9 g/dl
- •- Bilirubin <= 1.5 x ULN, or <= 5 x ULN in case of hepatic metastasis
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN, or <= 5 x ULN in case of hepatic metastasis
- •- Creatinine <= 1.5 x ULN
- •- International Normalized Ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT) in the normal range
- •Life expectancy of at least 12 weeks.
- •Written informed consent given before any study-related activities are carried out.
- •Willingness to comply with study protocol requirements.
排除标准
- •Progressive disease either during HT for early BRCA (adjuvant therapy) or within 12 months of completing such therapy.
- •HER2 receptor-positive BRCA defined as follows: Immunohistochemistry (IHC) staining of 3+ (uniform, intense membrane staining of > 30% of invasive tumor cells), or a fluorescent in situ hybridization (FISH) result of > 6 HER2 gene copies per nucleus, or a FISH ratio (HER2 gene signals to chromosome 17 signals) > 2.2.
- •Autoimmune disease that, in the opinion of the investigator, could compromise the safety of the subject. (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 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.
- •Receipt of immunotherapy (e.g., interferons, tumor necrosis factor, interleukins, or growth factors [GM-CSF, G-CSF, 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.
- •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 BRCA.
- •Prior radiotherapy to the site of cancer, if only one site will be used for evaluation of tumor response.
- •Central nervous system disease or brain metastases, as documented by CT or MRI scan.
- •Medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements.
- •Clinically significant cardiac disease, e.g. cardiac failure of NYHA classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, or myocardial infarction in the previous six months as confirmed by an ECG.
- •Splenectomy.
- •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.
- •Participation in another clinical study within 30 days prior to randomization.
- •Known hypersensitivity to the study drugs.
- •Known alcohol or drug abuse.
- •Legal incapacity or limited legal capacity.
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- •Subject who could be regarded as vulnerable according to ICH GCP guidelines (e.g., the subject*s willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or
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