ISRCTN86894592已完成2 期

Pre-surgical effects of serms, anti-COX-2 and aromatase inhibitors in breast cancer patients: a phase II randomized controlled trial

European Institute of Oncology [Fondazione Istituto Europeo di Oncologia (FIEO)] (Italy)0 个研究点目标入组 125 人开始时间: 2012年9月11日最近更新: 2019年5月5日

适应症

试验速览

•1. Female, aged at least 18 years old, no upper age limit
•2. Performance status = 0 (SWOG)
•3. Histologically-confirmed ER+ primary breast cancer candidated for conservative surgery
•4. Stage T1-2, N0-1, M0 or women with larger tumors who refuse chemo and/or endocrine therapy before surgery
•5. No previous treatment for breast cancer
•6. Provision of written informed consent

•1. Previous treatment for breast cancer including chemotherapy and endocrine therapy
•2. Patients eligible to neoadjuvant chemo and/or endocrine therapy
•3. Evidence of previous superficial or deep venous thrombosis or other thrombo-embolic events of relevance (pulmonary embolism, stroke, etc)
•4. Current anti-coagulant therapy
•5. Moderate to severe alteration in hematologic profile, hemostasis, renal and hepatic metabolism
•6. Clinically active peptic ulcer or gastroenteric disease
•7. Severe retinal disease
•8. Severe endometriosis (grade III-IV) or other proliferative disorders of the endometrium
•9. Clinically active neurologic or psychiatric disease
•10. Other medical contraindications as judged by the investigator
•11. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
•12. Pregnancy or current breast feeding (women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment)

发起方

European Institute of Oncology [Fondazione Istituto Europeo di Oncologia (FIEO)] (Italy)