Cancer: Breast Cancer
Conditions
Interventions
Randomised test intervention vs standardized intervention, non-blinded (Phase III)
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. 100 RMH female patients undergoing duct excision biopsy for the routine management of PND with symptoms of either spontaneous symptomatic discharge from a single duct 2. Patients with bloodstained nipple discharge or abnormal cytology of the duct fluid 3. Routine preoperative screening: mammogram and ultrasound, where appropriate, in accordance with the breast unit protocol 4. Have not had previous periareolar incisions or surgical biopsy in the same quadrant as the target lesion 5. Have intact nipples 6. Have an ECOG score of 0-1 7. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Currently pregnant or pregnant within the past 6 months 2. Currently lactating or lactated within the past 6 months 3. Have received chemotherapy within the past 6 months 4. Have an active infection in the breast 5. Have a previous history of breast cancer (including invasive carcinoma, Paget?s disease and DCIS) 6. Have silicone injections or breast implants (pre-pectoral) that disrupt the ductal architecture of the breast 7. Have prior breast surgery that may cause the ductal system not to communicate with the nipple, as determined by the clinician 8. Be unwilling or unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Successful visualisation of lesions in the duct endoscopy group correlating to pathological findings 2. Size of the tissue resection in the DE versus no DE group | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed