NCT00623519已完成不适用
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
研究概览
简要总结
To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Provision of Informed Consent
- •Resectable breast cancer patients, with histological confirmation
- •Patients eligible to receive hormonal adjuvant treatment with Anastrozole
- •They are allowed patients treated with adjuvant chemo or radiotherapy concurrently
- •Patients previously treated with Tamoxifen that had to withdraw treatment due to other reason than endometrial changes are allowed
- •Postmenopausal patients(aged 50 years or over/ without menses in the last months/ FSH level >40UI/L / women under 50 years with FSH levels>40UI/L).
- •Women showing progesterone and/or estrogen receptors positive.
排除标准
- •Patients with evidence of metastatic disease
- •Patients unsuitable to receive the medication according the Anastrozole label
- •Patients not giving their Informed Consent
结局指标
主要结局
Global incidence of endometrial changes during the adjuvant treatment with Anastrozole
时间窗: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment.
次要结局
- To describe the endometrial changes both clinically(vaginal bleeding) and through the scan.(During the study, at least annually)
- Histological assessment when indicated(type of hyperplasia)(When applicable)
- To assess global incidence of endometrial changes in this patient population before taking Anastrozole(During the study)
- To evaluate type of surgery required for endometrial changes control(hysterectomy rate)(During the study)
- To assess treatment tolerability(During the study)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Endometrial Evaluation in Cases of Postmenopausal BleedingPostmenopausal BleedingNCT03847415Cairo University100
招募中
不适用
Health communication survey in elderly womeFactors influencing health status and contact with health serviscesKCT0001335Korea Centers for Disease Control and Prevention400
已完成
不适用
A Randomised Control Trial to Compare the Effects of Hydroxyapatite Preparations, Calcium Citrate and Calcium Carbonate on Serum Calcium and Markers of Bone Turnover in Healthy Postmenopausal Women.Vascular diseaseMetabolic and Endocrine - Other metabolic disordersMusculoskeletal - OsteoporosisCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemOsteoporosisACTRN12611000232932The University of Auckland100
进行中（未招募）
不适用
Endometrial Changes in Breast Cancer Women.Endometrial CancerEndometrial Hyperplasia With AtypiaTAMBreast CancerNCT05717634Regina Elena Cancer Institute829
已完成
不适用
Vulvovaginal Atrophy Correction Using Neodymium LaserPostmenopausal PeriodVaginal AtrophyFemale Urogenital DiseasesNCT04735549MeLSyTech, Ltd120