Ductal carcinoma in situ Cancer Intraductal carcinoma in situ
Conditions
Interventions
Comprehensive site training will be complimented by a patient-friendly DVD designed to ensure consistent and appropriate use of terminology. Patients will be randomised between standard surgery and ac
Follow Up Length: 120 month(s)
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Age
46 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 16/06/2026: 1. Female, aged 46 years or above 2. Screendetected or incidental microcalcification 3. Histologically confirmed diagnosis of non-high-grade DCIS confirmed by local pathologist (for both breasts if bilateral disease) by: Small volume core biopsy and vacuum-assisted core biopsy (VACB) Or VACB alone as a first-line diagnostic approach Or Small volume biopsy or VACB plus open diagnostic surgical biopsy (without clear margins) Or Open diagnostic surgical biopsy (without clear margins) (in accordance with the current NHSBSP Guidelines for Pathology Reporting in Breast Cancer Screening) 4. DCIS diagnosed =90 days before registration 5. Bilateral disease is permitted if both sides are confirmed to be non-high-grade DCIS by local pathologist and the diagnosis is made within the same treatment episode 6. Able to give informed consent and comply with the trial schedule 6. Patient fit and willing to undergo surgery 7. Written informed consent obtained Previous inclusion criteria: 1. Female, aged 46 years or above 2. Screendetected or incidental microcalcification (unilateral or bilateral) 3. Histologically confirmed diagnosis of nonhigh grade DCIS confirmed by local pathologist on either small volume core biopsy or VACB (in accordance with the current NHSBSP Guidelines for Pathology Reporting in Breast Cancer Screening) 4. DCIS diagnosed =90 days before registration 5. Able to give informed consent and comply with the trial schedule and completion of Patient Reported Outcome questionnaires 6. Patient fit to undergo surgery 7. Written informed consent obtained
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 16/06/2026: 1. Previous or current diagnosis of invasive cancer or previous ipsilateral DCIS (previous surgically treated contralateral DCIS is permitted) 2. A mass lesion clinically or on imaging which has not been proven on biopsy to be a specific benign lesion 3. Surgical procedure with curative intent (even if clear margins have not been achieved) 4. Unequivocal comedo necrosis observed 5. Any serious and/or unstable pre-existing condition that would prevent compliance with the trial or the consent process 6. Recent-onset ipsilateral bloodstained nipple discharge without benign explanation 7. High-risk group for developing breast cancer (as defined in current NICE guidelines for familial breast cancer, or due to prior exposure to mantle field radiotherapy) Previous exclusion criteria: 1. Previous diagnosis of invasive cancer or ipsilateral DCIS (previous surgically treated contralateral DCIS is permitted) 2. A mass lesion clinically on mammogram or on ultrasound scan (if performed) at the site of the microcalcification before biopsy 3. Any serious and/or unstable preexisting medical, psychiatric, or other condition that would prevent compliance with the trial or consent process 4. Recent onset ipsilateral bloodstained nipple discharge, unless cytology and/or Ultrasound Scan (USS) confirmed concomitant duct ectasia 5. High risk group for developing breast cancer (as defined in current NICE guidelines for familial breast cancer, or due to prior exposure to mantle field radiotherapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ipsilateral invasive breast cancer free survival rate; Timepoint(s): 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
England, United Kingdom
Outcome results
None listed