EUCTR2011-006224-21-BE进行中（未招募）1 期
A pre-operative window study evaluating Denosumab, a RANK-Ligand (RANKL) inhibitor and its biological effects in young pre-menopausal women diagnosed with early breast cancer - D-BEYOND
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 39
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
- •1) Female gender
- •2) Age = 18 years
- •3) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •4) Premenopausal status defined as the presence of active menstrual cycle or normal menses during the 6 weeks preceding the start of study treatment. Plasma levels of estradiol, FSH and LH are required to document phase of menstrual cycle. In women previously exposed to hysterectomy, or were using hormonal intrauterine device at the time of enrollment, premenopausal levels of estradiol, FSH and LH are required to be eligible
- •5) Non metastatic operable newly diagnosed primary invasive carcinoma of the breast that is:
- •a. Histologically confirmed
- •b. Primary tumor size greater than 1.5 cm, measured by any of clinical examination, mammography, ultrasound or magnetic resonance imaging
- •c. Any clinical nodal status
- •d. Fully operable and not fixed to chest wall.
- •6) Known HER2 status
- •7) Known estrogen receptor status (ER) and progesterone status (PgR)
- •8) Patient has adequate bone marrow and organ function as shown by:
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- Platelets = 100 x 109/L
- •- Hemoglobin (Hgb) = 9.0 g/dL
- •- Serum creatinine = 1.5 x ULN
- •- Total serum bilirubin = 1.5 x ULN (in patients with known Gilbert Syndrome, a total bilirubin = 3.0 x ULN, with direct bilirubin = 1.5 x ULN)
- •- AST and ALT = 1.5 x ULN
- •- Random blood sugar (RBS) = 200 mg/dL or = 11.1 mmol/L
- •- HbA1c = 8 %
- •9) Albumin-adjusted serum calcium = 8.0 mg/dL (= 2.0 mmol/L)
- •10) Women of childbearing potential must agree to use active local contraception method for the duration of the study and for at least 7 months after the last dose of study treatment
- •11) Patients are required to take calcium and vitamin D supplementation until the completion of the study treatment
- •12) Written informed consent form (ICF) for all study procedures according to local regulatory requirements prior to beginning of the study
- •13) Patients accept to make available tumor and normal tissue samples for submission to central laboratory at the Jules Bordet Institute, Brussels, Belgium, to conduct translational studies as part of this protocol.
- •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 39
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) History of any prior (ipsi and/or contralateral) breast cancer
- •2) Any clinical” T4 tumor defined by TNM including inflammatory breast cancer
- •3) History of non-breast malignancies within the 5 years prior to study entry (except carcinoma in situ of the cervix, of the colon, melanoma in situ and basal cell and squamous cell carcinomas of the skin)
- •4) Prior or planned systemic anti-cancer therapy before definitive surgery
- •5) Unhealed or planned dental/oral surgery, current or previous osteonecrosis or osteomyelitis of the jaw
- •6) Pregnant or lactating women or women of childbearing potential without a negative serum or urinary pregnancy test within 7 days prior to starting study treatment; irrespective of the method of contraception used
- •7) Active Hepatitis-B virus (HBV), Hepatitis-C virus (HCV) or human immunodeficiency virus (HIV) infection
- •8 )Known hypersensitivity to denosumab
- •9) Bilateral invasive tumors
研究者
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