Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.
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
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- •Age of at least 45 and at most 55 years.
- •Performance status (Karnofsky-Index) >80%
- •Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures).
- •No clinical evidence of local recurrence or distant metastases.
- •Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
- •Patients have taken the SERMs as endocrine therapy for 2-4 years.
- •Patients who have had amenorrhea for at least half a year.
- •Life expectancy of at least 10 years, disregarding the diagnosis of cancer.
- •Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
- •Patients must be available for and compliant to treatment and follow-up.
- •Patients registered on this trial must be treated and followed up at the participating center.
排除标准
- •Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- •Hormone receptor-negative breast cancer.
- •Local recurrence and/or metastasis of breast cancer.
- •History of hysterectomy.
- •Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
- •History of osteoporosis and/or fractures due to osteoporosis.
- •Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- •Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
- •Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- •Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
研究组 & 干预措施
Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
干预措施: Tamoxifen (Drug)
Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
干预措施: Anastrozole (Drug)
Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
干预措施: Toremifene (Drug)
Succeeded group
Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.
干预措施: Anastrozole (Drug)
No chang group
Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.
干预措施: Tamoxifen (Drug)
No chang group
Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.
干预措施: Toremifene (Drug)
结局指标
主要结局
Disease free survival
时间窗: 10 years
Overall Survival
时间窗: 10 years
次要结局
- Disease Free Survival(5 years)
- Overall Survival(5 years)
研究者
Qiang SUN
Chief of Breast Surgery Department, Professor
Peking Union Medical College Hospital