T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety profile
研究概览
简要总结
This is a concise single arm, feasibility study, which will be executed in the University Medical Center Groningen, The Netherlands. Male patients with metastatic BC (n=6) are eligible for this study after at least 1 line of conventional endocrine therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A history of proven ER+ (>10% of cells), AR+ (>10% of cells), and HER2- metastatic BC
- •Tumor progression after at least one line of conventional endocrine therapy (tamoxifen, AI, fulvestrant, CDK4/6, ±LHRH analogue).
- •Age ≥ 18 years
- •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 (ULN)
- •Creatinine clearance >50mL/min
- •Prothrombin time, partial thromboplastin time and INR <1.5 x ULN
- •Written informed consent
排除标准
- •History of prostate, testicular or liver cancer
- •Patients already using testosterone supplements
- •Patients using medication with anti-androgenic effects (e.g. spironolactone)
- •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.
- •Hematocrit >50%
- •Patients with uncontrolled hypertension, diabetes mellitus or other significant cardiovascular morbidity.
- •Patients with recent history of coronary artery disease or trombo-embolic events within 6 months prior to screening
- •Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment
- •Visceral crisis and/or rapid progression necessitating chemotherapy
- •Previous allergic reaction to androgen agonists
- •Contra-indication for PET imaging
- •Tamoxifen or fulvestrant treatment <5 weeks prior to FES-PET.
研究组 & 干预措施
treatment
After the baseline imaging with FES- and FDHT-PET is completed, tamoxifen 20mg 1dd1 (standard dosage) plus testosterone (Androgel®) will be started. The first 3 patients will receive 25mg testosterone once daily (half the standard starting dosage for male hypogonadism). If this is well tolerated after 3 weeks, the dosage will be increased to 50mg once daily. Out of precaution, the safety profile of the 50mg dosage in the first 3 patients will be evaluated after all 3 patients have received 50mg testosterone for 2 cycli (8 weeks), prior to proceeding to the next 3 patients. Patients will be treated with tamoxifen and testosterone until disease progression or unacceptable toxicity.
干预措施: AndroGel (Drug)
结局指标
主要结局
Safety profile
时间窗: At 8 weeks and follow-up through study completion, an average of 1 year
Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.
次要结局
- Treatment response(8 weeks)
- Adverse events based on dosages(At 8 weeks and follow-up through study completion, an average of 1 year)
- AR to ER ratio(At baseline)
- Imaging and response(At 8 weeks and follow-up through study completion, an average of 1 year)