Scar placement over the tumour versus hidden locations in breast-conserving surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will compare patient-reported outcomes and clinical results for women undergoing standard breast-conserving surgery with scars placed either directly over the lesion or in remote/hidden locations. Participants will complete the validated BREAST-Q questionnaire to measure satisfaction, appearance, and function after surgery, with comparisons made between the two scar-location groups. The study includes adult women with invasive cancer or DCIS eligible for breast-conserving surgery and collects short- and longer-term PROMs and clinical outcome data. Results aim to inform counselling about scar placement choices during surgical planning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients ≥18 years of age
* Able to provide written informed consent
* Invasive breast cancer or ductal carcinoma in situ (DCIS) suitable for sBCS (including multifocal cancers requiring x2 wires or magseeds)
* Able to understand and complete the questionnaire

Scar over the lesion defined as radial, transverse, vertical, oblique scar over the tumour lesion location in the breast Remote incisions defined as lateral perimeter/periareolar/infra-mammary fold/ benelli/hemi-batwing

* No restrictions on tumour size (decision on suitability for sBCS will be based on clinical assessment)
* Any axillary nodal staging status
* Bilateral cancers allowed
* Post neo-adjuvant chemotherapy (NACT) allowed

Exclusion Criteria:

* Male patients (BCS not proven as standard of care) or transgender
* Patients undergoing oBCS (such as wise pattern, vertical scar mastopexy incision pattern or volume replacement chest wall perforator flap)
* Patients undergoing mastectomy with or without immediate autologous or implant reconstruction
* Patients requiring nipple excision (central wide local excision)
* Patients undergoing wide local excision under local anaesthetic
* Women not able or willing to give informed consent
* Where close tumour proximity to skin or skin involvement necessitates skin excision over the tumour
* Patients diagnosed with locoregional recurrence
* Patients diagnosed with associated distant metastasis
* Patients undergoing diagnostic excision surgery for atypical breast lesions or benign lesions
* Patients diagnosed with phyllodes lesion
* Patients who have had previous ipsilateral breast surgery (any type)

Where it's running

• St James's University Hospital
  Leeds, West Yorkshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Sue Dr Hartup, PhD, RN — Leeds Teaching Hospitals NHS Trust
• Study coordinator: Sue M Dr Hartup, PhD, RGN
• Email: s.hartup@nhs.net
• Phone: +44 0113 2068628

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.