EUCTR2005-000661-19-GB进行中（未招募）不适用
eoadjuvant hormone therapy for postmenopausal women with ER and/or PgR positive primary breast cancer: A multi-center study to determine the optimum length of treatment with Femara (letrozole 2.5mg daily) on tumour regression to permit breast conserving surgery.
ovartis Pharmaceuticals UK Ltd0 个研究点开始时间: 2005年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Postmenopausal women able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy (see appendix I: Preparation of core biopsies), whose tumours are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 30% positive malignant epithelial cells. Where tumours are bilateral, the reference side should be that with the larger or largest tumour at baseline.
- •2. Clinical Stage T2 or >T2 tumours which in the investigators opinion would not be eligible for breast-conserving surgery. The nodal status will be evaluated by palpation and/or ultrasound.
- •3. Post menopausal status defined by one of the following:
- •Women with an intact uterus and
- •= 55 years of age OR
- •< 55 years of age without menses for the last 5 years OR
- •< 55 years of age and has not had menses for at least the last 12 months (but has had menses in the last 5 years) and has postmenopausal levels of FSH (according to the postmenopausal range of the individual laboratory, and performed at least four weeks after stopping HRT/oral contraceptives).
- •OR In the case of women without an intact uterus and
- •= 55 years of age OR
- •>55 years of age and postmenopausal levels of FSH (according to the postmenopausal range of the individual laboratory, and performed at least four weeks after stopping HRT/oral contraceptives)
- •Bilateral oophorectomy (prior to the diagnosis of breast cancer).
- •4. Tumour measurable by clinical examination, mammography and ultrasound.
- •5. Adequate bone marrow function as shown by: WBC =3.5 x 109/L, ANC = 1.5 x 109/L, Platelets = LLN, Hb >10g/dL.
- •6. Adequate liver function as shown by: serum bilirubin = 1.5 x ULN, albumin = 3 g/dl, serum transaminases activity = 2.5 x ULN, alkaline phosphatase = 2.5 x ULN.
- •7. Normal renal function (serum creatinine = 1.5 x ULN, BUN = 1.5 x ULN).
- •8. A life expectancy of at least 6 months.
- •9. Written informed consent to the core study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Multifocal disease
- •2. Prior treatment with aromatase inhibitors or antiestrogens, or known hypersensitivity to these compounds.
- •3. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hyper- or hypothyroidism, Cushing´s Syndrome, Addison´s disease (treated or untreated).
- •4. Patients with unstable angina, uncontrolled cardiac disease (e.g. Class III or IV New York Heart Association's Functional Classification).
- •5. Patients who are eligible for breast conserving surgery.
- •6. Evidence of inflammatory breast cancer or distant metastasis.
- •7. Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin´s disease or NHL, provided 5 years have elapsed from completion of therapy, and there has been no recurrence.
- •8. Concomitant anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (BRM’s), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued as concomitant therapy. Patients who have received HRT will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.
- •9. Concomitant treatment with steroids, e.g. glucocorticoids for indications other than cancer, except aerosol for obstructive airways diseases and steroid injection to the joints for treatment of inflammation.
- •10. Other investigational drugs within the past 30 days and the concomitant use of investigational drugs.
- •11. History of non-compliance to medical regimens and patients who are considered potentially unreliable.
- •12. Any history of frank or uncontrolled osteoporosis (anti-osteoporotic treatment is permitted).
- •13. History of any other condition which may effect participation in the study.
研究者
相似试验
进行中（未招募）
不适用
eoadjuvant therapy for postmenopausal women with ER and/or PgR positive breast cancer. A randomized open phase II trial evaluating the efficacy of a 6 months preoperative treatment withLetrozole (2.5 mg/day) with or withoutZoledronic acid (4 mg every 4 weeks). - FEMZONEEUCTR2004-004007-37-DEovartis Pharma GmbH
已完成
3 期
IBCSG 14-93 - Adjuvant therapy for post/peri menopausal patients with node positive breast cancer who are not suitable for endocrine therapy aloneBreast CancerACTRN12607000034437International Breast Cancer Study Group760
进行中（未招募）
1 期
ocal Oestrogen Treatment in Postmenopausal Women Undergoing Pelvic Organ Prolapse Surgery (LOTUS)EUCTR2014-000179-18-GBniversity of Birmingham100
已完成
3 期
IBCSG 12-93 - Adjuvant therapy for post/perimenopausal patients with node positive breast cancer who have oestrogen receptor positive tumoursCancer - BreastBreast CancerACTRN12606000532505International Breast Cancer Study Group960
已完成
3 期
IBCSG VIII - Adjuvant therapy in pre- and peri-menopausal patients with node negative breast cancerCancer - BreastBreast CancerACTRN12607000037404International Breast Cancer Study Group1,200