Study of the Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk After Initial Treatment in Patients With Non-metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Evaluate the bone impact of hormone therapy remotely
研究概览
简要总结
Breast cancer is the most frequently observed cancer in women in France.The mortality rate is still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the improvement in available treatments.For patients with breast cancer expressing hormone receptors, treatment with Tamoxifen or anti-aromatase can have the risk of the cancer coming back.However, these treatments have many side effects, including the risk of osteoporosis and metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with Tamoxifen.These effects have been well studied while taking hormone therapy.However, very few studies have analyzed the impact of these treatments after stopping them in women who have had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution of the health risk after initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients who had T1-T3, N0-N2, M0 breast cancer
- •Patients referred to the Menopause center in the context of their breast cancer who were included in the original study evaluating the bone impact of hormone therapy carried out between 2010 "Bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast "
- •Patient who has given her consent for the study (written or verbal) after clear and fair information
排除标准
- •Metastatic breast tumor
- •Absence of adjuvant hormone therapy for patients whose tumor did not express hormone receptors
- •Patients who have died since the last assessment
- •Protected adult patient (guardianship, curatorship, safeguard of justice)
结局指标
主要结局
Evaluate the bone impact of hormone therapy remotely
时间窗: Inclusion day (day 0)
A questionnaire asking patients if they have fractures since stopping the treatment will be offered.
Evaluate the cardiovascular impact of hormone therapy remotely
时间窗: Inclusion day (day 0)
A questionnaire asking patients if they have had a cardiovascular problem since stopping treatment will be offered.
次要结局
未报告次要终点