Protocol for the management of screen detected ductal carcinoma in situ (DCIS) of the breast

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12606000510549
• Lead Sponsor: Breast Cancer Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1996-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Patients with unilateral or bilateral DCIS 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. 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. Informed consent. Note: The wish to continue hormone replacement therapy for menopausal symptoms or the contraceptive pill will not exclude the patient from trial entry. Continued or subsequent use will be recorded on the follow-up form.

Exclusion Criteria

Paget's disease of the nipple. Lobular carcinoma in-situ or atypical hyperplasia of the breast in the absence of DCIS. Note: Patients with in-situ carcinoma which is of mixed lobular and ductal type are eligible. Cases in which the pathologist is unable to state that the excision margins are clear, even after re-excision. Histologically confirmed involvement of any axillary lymph nodes, indentified either as an incidental finding on examination of a CLE specimen or as a result of excision of a palpable node, constitutes invasion irrespective of breast histology. Patients for whom any of the treatment options are considered inappropriate. Patients with a reduced life expectancy due to either prior or concomitant invasive malignant disease or a non-malignant condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival[Duration defined as the time from randomisation to relapse, appearance of a second primary tumour, or death from any cause, whichever occurs first.];Overall Survival[Duration is defined as the time from randomisation to death of any cause.]

Secondary Outcome Measures

Name	Time	Method
Systemic Relapse (is defined as any recurrent disease in sites other than ipsilateral or contralateral breast only).[At the time systemic relapse is diagnosed.]