NCT02344940已完成4 期
Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer: A Randomized, Controlled, Prospective, Observational Study
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- incidence of ovarian cyst
研究概览
简要总结
To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years, premenopausal
- •Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive
- •Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy.
- •Leukocyte ≥ 3*109/L; Platelets ≥ 75*109/L; Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal (UNL) range Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range; Written informed consent according to the local ethics committee requirements.
- •Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;
排除标准
- •Histologically confirmed hormonal receptor negative.
- •Have received neoadjuvant/adjuvant endocrine therapy.
- •With metastatic tumor.
- •Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
- •Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
- •With any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc.
- •With any of complications that will decrease sex hormone level:hyperthyroidism，hypothyroidism，liver cirrhosis，severe malnutrition，Turner's syndrome，sex hormone synthetase deficiency, intracranial tumor, pituitary atrophy, etc.
- •Ovarian ablation or suppression
- •With severe non-malignant co-morbidity that will influence long-term follow up.
- •With severe hepatic dysfunction, Child-Pugh C.
- •With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse.
- •Known severe hypersensitivity to any drugs in this study;
研究组 & 干预措施
toremifene
Experimental
patients who will be treated with toremifene.
干预措施: Toremifene (Drug)
tamoxifen
Active Comparator
patients who will be treated with tamoxifen.
干预措施: Tamoxifen (Drug)
结局指标
主要结局
incidence of ovarian cyst
时间窗: participants will be followed during the first year of endocrine therapy
Ovarian cyst is defined as a purely liquid-filled structure that was equal to or exceeded 2 cm in its largest diameter detected by transvaginal ultrasonography.Participants will be required to receive transvaginal ultrasonography every 3 months.
次要结局
- incidence of endometrial thickening(participants will be followed during the first year of endocrine therapy)
- change of female hormones(participants will be followed during the first year of endocrine therapy)
- change of blood lipid(participants will be followed during the first year of endocrine therapy)
- change of liver function(participants will be followed during the first year of endocrine therapy)
- incidence of fatty liver(participants will be followed during the first year of endocrine therapy)
- change of Kupperman index(participants will be followed during the first year of endocrine therapy)
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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