ISRCTN22614215已完成不适用

Randomised trial testing observation (no radiotherapy) against radiotherapy in women with low-risk completely excised oestrogen receptor positive ductal carcinoma in situ of the breast on adjuvant endocrine therapy

Sponsor not defined - Record supplied by Institute of Cancer Research (UK)0 个研究点目标入组 2,000 人开始时间: 2004年4月13日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Unifocal DCIS without an invasive component. Patients with microinvasion (defined as one or more foci of invasion each less than 1 mm) may be included
•2. Complete microscopic excision with a MINIMUM radial margin of 1 mm
•3. ER positive or progesterone receptor (PgR) positive (either more than 10% tumour cells staining for receptor or a cut point of more than two)
•4. Maximum microscopic tumour diameter must be less than 30 mm (less than 15 mm if grade III)
•5. Primary surgery within six months of randomisation
•6. The majority of women will be postmenopausal and all should be between the ages of 50 and 75 years. Postmenopausal status is defined as meeting one or more of the following criteria:
•6.1. Aged over 60
•6.2. Bilateral oophorectomy
•6.3. Aged under 60 with a uterus and amenorrhoea for at least 12 months
•6.4. Aged under 60 without a uterus and with follicle-stimulating hormone (FSH) more than 20 IU/L
•6.5. Off Hormone Replacement Therapy (HRT) for more than four weeks and with an FSH more than 20 IU/L. Premenopausal and perimenopausal women (over 50 years of age) are eligible for DCIS II but not for IBIS II study
•7. Fully informed signed consent
•8. Patient available for long-term follow up
•All post-menopausal women will potentially be eligible for IBIS II.

•1. Aged under 50 years
•2. ER negative DCIS or PgR negative (less than 10% cell staining positive immunohistochemically or a cutpoint of less than two)
•3. Any previous cancer in the past five years (except non-melanoma skin cancer or in situ cancer of the cervix)
•4. Current treatment with anti-coagulants
•5. Previous deep vein thrombosis or pulmonary embolus
•6. Previous tamoxifen or raloxifene use for more than three months
•7. Any woman with unexplained postmenopausal bleeding
•8. Tumour incompletely excised
•9. DCIS lesions equals 30 mm maximum microscopic diameter (more than 15 mm if grade III)
•10. Patient treated by mastectomy
•11. Patients unable to undergo follow-up
•12. Any condition precluding full dose radiotherapy to the breast

发起方

Sponsor not defined - Record supplied by Institute of Cancer Research (UK)