PER-042-08已完成未知
PHASE III STUDY THAT EVALUATES THE CONTINUOUS LETROZOLE ROLE VERSUS INTERMITTENT LETROZOLE FOLLOWING 4 TO 6 YEARS OF PREVIOUS ADJUVANT ENDOCRINE THERAPY FOR POSTMENOPAUS WOMEN WITH POSITIVE HORMONAL RECEPTORS, LYMPHATIC GANGLIONARIC AFFECTION IN PREVIOUS BREAST CANCER
ABBOTT LABORATORIOS S.A., INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.,0 个研究点目标入组 0 人开始时间: 2009年1月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- Female
入选标准
- •Patients must be postmenopausal, according to any of the following criteria, given that letrozole is ineffective in pre- or perimenopausal patients, and may stimulate ovarian function, confirmation of postmenopausal status is required.
- •Patients of any age who have undergone bilateral oophorectomy (including castration for radiotherapy and amenorrhea for> 3 months)
- •Patients 56 years of age or older. If the patient presents any evidence of ovarian function, biochemical evidence of definitive postmenopausal status (defined as postmenopausal levels of estradiol, LH and FSH) is required.
- •Patients 55 years of age or younger should have biochemical evidence of a definitive postmenopausal status (defined as postmenopausal levels of estradiol, LH, and FSH). Patients who have received analogues of LHRH during the previous year are eligible if they meet the criteria described above for confirmation of postmenopausal status.
- •Patients must be accessible for follow-up
- •Characteristics of the disease
- •At the time of diagnosis, patients must have had a resectable, non-inflammatory breast cancer.
- •Patients must be clinically free of disease at the time of randomization. (Note: it is recommended, but it is not required that the disease-free status be verified through an abdominal ecotomography, chest X-ray and bone scintigraphy (in case of symptoms). Mammography is recommended within 1 year prior to randomization).
- •Patients must have had a tumor with positive steroidal hormone receptor (RE and / or RPg), determined by immunohistochemistry, after surgery and prior to the start of previous endocrine therapy.
- •After primary surgery, eligible patients must have had evidence of lymph node involvement, either in the axilla or in the internal mammary chain, but without supraclavicular involvement.
排除标准
- •There must not have been evidence of a recurrence of the disease or distant metastatic disease at any time prior to randomization.
- •Patients with bilateral breast cancer are not eligible.
- •Patients who have had a bone fracture secondary to osteoporosis at any time during the 4-6 years of hormone therapy with SERMs / AI are not eligible.
- •Patients with another previous or concomitant malignancy are not eligible, EXCEPT the following adequately treated: basal cell or squamous cell carcinoma of the skin, cervical or bladder carcinoma in situ, carcinoma in situ of contra-or ipsilateral breast.
- •Patients with non-malignant systemic comorbidity (cardiovascular, renal, pulmonary, etc.) who would avoid long-term follow-up are not eligible.
- •They are not eligible: patients with psychiatric disorders, addictive, or any disorder that interferes with the adherence of the patient to the indications of the protocol.
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