The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer

A TDC interbreast ratio ≥ 1.28 in any quadrant will be used as an indicator of breast lymphedema

Skin thickness >1.60 mm in superior and lateral quadrants, >2.0 mm in the medial and inferior quadrants will be used as an indicator of breast lymphedema.

Breast Cancer Treatment Outcome Scale (BCTOS-12) Minimum Score = 12, Maximum Score = 48 Higher score indicates worse outcome

Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales i. Psychosocial Well-Being (min score 10, max score 50), higher score indicating better outcome

Patient and Observer Scar Scale Linear Scar Version 3.0

This is a validated measure used to administer clinical examination of the breast, trunk and upper extremity for lymphedema

The following will be assessed:

• Each breast quadrant: Presence or absence of pitting edema
• The participant is placed in supine. The examiner's thumb is placed firmly on the participant's skin, applying sustained pressure to the skin and superficial tissue for one minute. Upon release of the pressure, an indentation of the tissue at the test site is defined as pitting and is recorded as Yes in the relevant quadrant. If there is no change in the tissue, record No to pitting oedema.

The following will be assessed:

• Each breast quadrant, lateral chest wall and inframammary tissues: Presence or absence of peau d'orange
• The participant is positioned sitting. The examiner slightly compresses the breast tissue between their first finger and thumb to look for the orange peel appearance to the skin. A light can be shone tangentially across the breast to assist in identifying peau d'orange.

The following will be assessed:

• Each breast quadrant: Presence or absence of tissue fibrosis
• The participant is placed in supine. The examiner uses their first finger and thumb to palpate the tissue and gently pinch the tissue to assess for any tissue thickening, increased firmness or density and/or tissue retraction or fixation, compared to the equivalent tissue on the unaffected side. If the participant has had surgery on the unaffected breast (e.g. breast reduction), the tissue in the quadrant most distal to the incision site is used as the comparator tissue. N/A is marked in the table for the unaffected breast, unless the participant has had surgery on the unaffected side and tissue fibrosis is detected as a result compared to other quadrants of the unaffected breast.

The following will be assessed:

• Each breast quadrant: Presence or absence of tenderness to palpation.
• The examiner will lightly palpate the tissue of each breast quadrant to see if the participant reports any pain or tenderness. Deep palpation, particularly medially in the breast, may cause tenderness in the costochondral cartilages.

The following will be assessed:

• Each breast quadrant: Presence or absence of erythema (redness of the skin)

The following will be assessed:

• Scar measurements for the breast and axillary scars, including location (quadrant, distance from the center of the nipple to the center of the scar), scar length, width and orientation (vertical, horizontal, oblique or radial).

The following will be assessed:

• Lateral chest wall and inframammary tissue: The examiner will record presence or absence of visual fullness

The following will be assessed:

• Lateral chest wall and inframammary tissue: Presence or absence of the Stemmer sign. The Stemmer sign is a physical examination finding used to diagnose lymphedema. If the examiner cannot pinch the skin then this positive finding is associated with lymphedema. The Stemmer sign has been found to be a sensitive predictor for primary and secondary lymphedema with moderate specificity (Goss JA, Greene AK. Sensitivity and Specificity of the Stemmer Sign for Lymphedema: A Clinical Lymphoscintigraphic Study. Plast Reconstr Surg Glob Open. 2019 Jun 25;7(6):e2295. doi: 10.1097/GOX.0000000000002295. PMID: 31624689; PMCID: PMC6635205)

The following will be assessed by the examiner:

• Nipple and nipple-areolar complex: Tissue thickening on the side of surgery as compared to the unaffected side

The following will be assessed by the examiner:

• Nipple and nipple-areolar complex: Skin color changes as compared to the unaffected side (lighter, darker, same)

Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales ii. Sexual Well-Being (min score 6, max score 30), higher score indicating better outcome

Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales iii. Satisfaction with Breasts (min score 11, max score 44), higher score indicating better outcome

Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales iv. Physical Well-Being: Chest (min score 10, max score 30), higher score indicating better outcome

Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales v. Adverse Effects of Radiation (min score 6, max score 18), higher score indicating better outcome

Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales vi. Satisfaction with Information - Breast Surgeon (min score 12, max score 48), higher score indicating better outcome

Perometry will be undertaken per clinical protocol to screen for arm lymphedema

Bioimpedance Spectroscopy will be undertaken per clinical protocol

Clinical photographs of each breast, repeated for the right and then the left breast, taken per study protocol 5 positions each side, including a close up photo of the breast and surgical scar.