NL-OMON51371招募中不适用
T&T trial: adding Testosterone to Tamoxifen in male breast cancer patients - T&T trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
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
- •2. A history of proven ER+ (>10% of cells), AR+ (>10% of cells), and HER2-
- •metastatic BC
- •3. Tumor progression after at least one line of conventional endocrine therapy
- •(tamoxifen, AI, fulvestrant, CDK4/6, ±LHRH analogue).
- •4. Age >= 18 years
- •5. Adequate hematological, renal and liver function as follows:
- •Absolute neutrophil count > 1.5 x 109/L
- •Platelet count >100 x 109/L
- •White blood cell count >3 x 109/L
- •AST and ALT <2.5 or <5.0 in case of liver metastases x upper limit of normal
- •Creatinine clearance >50mL/min
- •Prothrombin time, partial thromboplastin time and INR <1.5 x ULN
- •6. Written informed consent
排除标准
- •1. History of prostate, testicular or liver cancer
- •2. Patients already using testosterone supplements
- •3. Patients using medication with anti-androgenic effects (e.g. spironolactone)
- •4. Elevated PSA (>4µg/L) or severe urinary tract problems (as defined with a
- •Prostate Symptom Score >19). Patients with known BRCA mutation and PSA *3 µg/L
- •will be referred to the urologist for prostate cancer screening, and can
- •participate if they have no signs of prostate cancer.
- •5. Hematocrit >50%
- •6. Patients with uncontrolled hypertension, diabetes mellitus or other
- •significant cardiovascular morbidity.
- •7. Patients with recent history of coronary artery disease or trombo-embolic
- •events within 6 months prior to screening
- •8. Severe concurrent disease, infection, co morbid condition that, in the
- •judgment of the investigator would make the patient inappropriate for
- •9. Visceral crisis and/or rapid progression necessitating chemotherapy
- •10. Previous allergic reaction to androgen agonists
- •11. Contra-indication for PET imaging
- •12. Tamoxifen or fulvestrant treatment <5 weeks prior to FES-PET.
研究者
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