nited Kingdom randomised trial for the management of screen-detected ductal carcinoma in situ (DCIS) of the breast
- Conditions
- Breast CancerCancer
- Registration Number
- ISRCTN99513870
- Lead Sponsor
- Cancer Research UK (CRUK) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1000
1. Unilateral or bilateral DCIS which is cosmetically suited to breast conservation, which has been detected as a result of attendance at a screening centre, which is without evidence of invasion, and which has been completely excised as determined by free margins on histological examination
2. Patients with similarly defined DCIS lesions, in whom the diagnosis of DCIS has been made as a result of mammograms taken following referral to a diagnostic clinic
3. Patients with Paget's disease of the nipple, lobular carcinoma in situ of the breast or atypical hyperplasia in the absence of DCIS are excluded
4. Pathologist must be able to state that the excision margins are clear, even after re-excision
5. No axillary lymph node involvement
6. Able to receive either treatment
1. Involved excision margins
2. Paget's Disease
3. Nodal spread
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Local control of disease <br>2. Any involvement of contralateral breast <br>3. Overall survival and cause-specific mortality
- Secondary Outcome Measures
Name Time Method ot provided at time of registration