EUCTR2009-015122-11-DE进行中（未招募）1 期
A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in male breast cancer patients. - GBG 54 - MALE
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
- 48
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
- Male
入选标准
- •1. Written informed consent for all study procedures.
- •2. Complete baseline documentation sent to GBG Forschungs GmbH.
- •3. Male patients.
- •4. Age = 18 years.
- •5. Karnofsky-Index = 60 %.
- •6. Histologically confirmed unilateral or bilateral carcinoma (enrolment possible in neoadjuvant, adjuvant and metastatic situation).
- •7. no target lesion necessary for metastatic situation
- •8. Positive hormone receptor status (e.g. ER and/or PR-receptor positive).
- •9. Completed staging prior randomisation (within 8 weeks after diagnose or last therapy (operation, chemotherapy or radiation): chest X-ray, ultrasound of the liver, bone scan).
- •In case of positive findings, further investigations are required to verify the findings as clinically indicated.
- •10. Prior chemotherapy is possible. In case of adjuvant treatment: adequate surgical treatment with histological complete resection including axillary lymph nodes if patients are included as adjuvant treatment. A sentinel lymph node biopsy is possible if the sentinel is not involved.
- •11. Normal cardiac function must be confirmed by ECG within three months prior to randomisation.
- •12. Laboratory requirements (= 14 days before therapy start):
- •- Hemoglobin = 9 g/dL,
- •- Leukocytes 4 - 10 x103/µL,
- •- Thrombocytes 150 - 400 x103/µL.
- •Hepatic function
- •- ASAT (SGOT) or ALAT (SGPT) = 2x UNL,
- •- Total bilirubin = 2x UNL.
- •Renal function
- •- Serum creatinine = 1.5x UNL,
- •- Creatinine clearance > 30mL/min (if creatinine is above UNL, according to Cockroft-Gault).
- •- Cholesterol 200 - 240 mg/dL (5.18 - 6.22 mmol/L),
- •- HDL cholesterol > 40 mg/dL (> 1 mmol/L),
- •- LDL cholesterol = 160 mg/dL (= 4 mmol/L).
- •- Prostate specific antigen (PSA): analysis has to be done
- •13. Two serum samples (5 mL) centrally made available.
- •14. Paraffin tumor tissue block and full blood sample centrally made available (except when the patient does not agree to central biomaterial collection).
- •15. The patient must be accessible for treatment.
- •Patients can simultaneously be registered in the register study of the University Hospital of Magdeburg.
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female patients.
- •2. Prior endocrine therapy of breast carcinoma.
- •3. Known or suspected hypersensitivity reaction to the compounds or incorporated substances.
- •4. No indication for endocrine treatment.
- •5. Life expectancy of less than six months.
- •6. International Prostate Symptom Score (IPSS) > 17.
- •7. Prostate carcinoma
- •8. History of prostate cancer within the last five years and regardless the time frame all patients with hormone receptor positive prostate carcinoma who have received endocrine treatment.
- •9. Concurrent neuronal or cardiac disease, poorly controlled arterial hypertension.
- •10. Previous thromboembolic event within the last five years (except for thromboembolic events correlated to implanted devices (e.g. port thrombosis)).
- •11. Currently active hepatitis.
- •12. Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel.
- •13. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
- •14. Patients who are not able to give informed consent as defined according to AMG.
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