Preoperative Irradiation for Stage I Breast Cancer

Frequency of toxicities (Adverse Events and Serious Adverse Events) including subcutaneous breast tissue, chest wall, fatigue, pain and wound healing issue as defined per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0, occurring within approximately 1 month after radiation therapy (RT).

Frequency of toxicities (Adverse Events and Serious Adverse Events) including subcutaneous breast tissue, chest wall, fatigue, pain and wound healing issues as defined per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0 occurring at and after 6 months after radiation therapy (RT).

Absence of residual invasive disease after treatment. Residual Cancer Burden (RCB) estimates residual disease in the tumor bed and lymph nodes post-neoadjuvant therapy. RCB values, determined by the pathologist, are derived using the largest two dimensions of the Primary Tumor Bed Area (mm) (largest tumor bed if multicentric disease), histological assessment of Overall Cancer Cellularity (as carcinoma percentage of area) and Percentage of Cancer That Is in situ Disease, along with Number of Positive Lymph Nodes (metastatic) and Diameter of Largest Nodal Metastasis (mm). RCB scoring classes, indicating progressively larger residual disease burden, are: RCB-0 (0 = pCR-no burden), RCB-1 (≥0-1.36-minimal burden), RCB-2 (1.37-3.28-moderate burden), and RCB-3 (>3.28-extensive burden).

The European Organization for Research and Treatment Quality of Life Questionnaire for Breast Cancer (EORTC QLQ BR23) is a breast-specific module that comprises of 20 four-level questions in five multi-item domains questions to assess functioning characteristics: body image, sexual functioning, sexual enjoyment, future perspective, and, symptom characteristics: systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss. Raw scores for each characteristic (ranging from 0 - 4) are linearly transformed to a 0 to 100 overall/total scale. Better level of functioning is represented by a higher functional score for each characteristic. More severe symptoms are represented by high symptom scores or items for each symptom.

Breast Cancer Treatment Outcome Scale (BCTOS) is a 17-item, self-report instrument of perceived aesthetic (e.g., breast shape) and functional status (e.g., pain, mobility) after breast conserving surgical treatment (BCT) and radiotherapy. The Aesthetic Status subscale is comprised of 12 items with total scores between 0-48; the Functional Status subscale is comprised of 5 items with total possible scores between 0-20. Patients asked to rate each item of the questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference, 2 = slight difference, 3 = moderate difference, 4 = large difference). The score for each subscale is the unweighted mean of the ratings over all items belonging to that subscale. Total score of the BCTOS is thus 0-68. A higher score reflects less symmetry between the treated and the untreated breast and is therefore considered a measure of poor status.

Reappearance (present after RT) of disease in the location/region in which initial disease appeared, as determined by physical exam and dedicated breast or systemic imaging using mammogram, MRI, CT, or PET scan.

Length of time after treatment that patient show no evidence of reappearance of breast cancer. Reappearance (present after RT) of disease is determined by physical exam and dedicated breast or systemic imaging using mammogram, MRI, CT, or PET scan.

Length of time from first study treatment until death due to any cause.

Digital images (photographs) will be taken of the breasts pre and post treatment. These digital images will later be evaluated for cosmetic results by a panel of physicians using diagnostic established Radiation Therapy Oncology Group (RTOG) criteria, with patients receiving a rating of between 1 and 4. RTOG criteria ratings: 1-4: 1 = Excellent (minimal change in size, shape, texture) 2 = Good (mild change in shape, size texture, presence of reddening or scaring) 3 = Fair (moderate changes in size, shape involving 1/4 or less of breast, greater presence of reddening and scaring), 4 = Poor (severe thickening, scarring, change in size and shape involving greater than 1/4 of breast).