Neoadjuvant Hormonal Treatment of Postmenopausal Women Who Have Operable Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound.
研究概览
简要总结
EFFICACY OF NEOADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE IN POMENOPAUSAL WOMEN WITH ER-POSITIVE BREAST CANCER.
Flavia Morales-Vásquez, Horacio Noé López Basave.
Background: Neoadjuvant Hormonal Therapy (HT) is being used increasingly to downstage locally advanced and large operable breast cancer. Following this treatment, inoperable breast cancer often becomes fully respectable and tumors requiring mastectomy may be successfully removed by breast-conserving surgery (BCS).
Methods: Recruit postmenopausal women with ER(+) and/or PgR (+) breast cancer (BC) T2,N1-2 to T3,N0-1 were assigned to HT with anastrozole 1 mgr daily for 4 months.
The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound. Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 66 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women who had primary breast cancer, histological confirmed, through a core needle biopsy, and who{s tumors positive for estrogens receptor ER/PR.
- •Clinical stage IIB or IIIA Tumor assessable by clinical exam, mammogram or and ultrasound Adequate functional bone marrow Documented evidence adequate renal function and liver function Life expectancy for six months Written inform consent
排除标准
- •Prior treatment with letrozole or tamoxifen uncontrol disorders patients with instable angina or uncontrol cardiac disease patient with bilateral breast tumors patients elegies for conservative breast surgery Inflammatory breast cancer o distant metastases Other concurrent malignancies, except carcinoma with in situ cono biopsy of uterine cervix or adequate treat skin cancer no melanoma concomitant cancer treatment such as chemotherapy, immunotherapy biological modulators, endocrinotherapy, biphosphonates therapy and radiotherapy.
- •Concomitant treatment with steroids Others research drug whiting the last 30 days and concomitant use of research drugs History non compliance with medications schedules and patients consider potential unreliable.
结局指标
主要结局
The primary endpoint was to compare overall objective response (OR) determined by clinical (palpation) and ultrasound.
次要结局
- Secondary endpoint was the number of patients who qualified for BCS plus radiotherapy.