Early-Stage Breast Cancer
Conditions
Keywords
partial breast irradiation, early-stage breast cancer, 1-week PBI, 3-week PBI
Brief summary
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.
Interventions
RADIATION3-week PBI
40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily
RADIATION1-week PBI
26Gy/5Fx/1w, 5.2Gy/Fx, once daily
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female patients with an estimated life expectancy greater than 5 years. * Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS). * For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm. * For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm. * Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation. * ECOG performance status 0 or 1. * Eligible for systemic therapy, without prior neoadjuvant systemic therapy. * Able to tolerate radiotherapy procedures and position immobilization. * No contraindications to radiotherapy. * Written informed consent provided.
Exclusion criteria
* Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma). * Positive axillary, internal mammary, or supraclavicular lymph nodes. * Presence of distant metastasis. * Paget's disease of the nipple. * History of prior ipsilateral or contralateral invasive breast cancer or DCIS. * Bilateral breast cancer. * Known germline BRCA1 or BRCA2 mutation. * Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes. * Active or prior second malignancy (except adequately treated non-melanoma skin cancer). * Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy. * Pregnant or lactating patients. * Inability or unwillingness to comply with scheduled follow-up visits. Inability or unwillingness to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year adverse cosmesis | 3 years | Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute adverse events | 6 months | The incidence and severity of acute adverse event include radiation dermatitis, pruritus, skin pain, radiation esophagitis, and radiation pneumonitis. |
| Late adverse events | 3 years | The incidence and severity of late adverse event include breast induration, skin hyperpigmentation, telangiectasia, breast oedema, and pulmonary fibrosis. |
| Locoregional recurrence | 5 years | Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes. |
| Distant metastasis | 5 years | Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral breast and regional nodes. |
| Overall survival | 5 years | Overall survival is the time from randomization to death from any cause. |
| Quality of life (QoL) | 5 years | Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). All multi-item scale and single-item scores are linearly transformed to range from 0 (minimum) to 100 (maximum). For the global health status/QoL and functional scales, higher scores represent better functioning and a better outcome; for the symptom scales and single items, higher scores represent greater symptom severity and a worse outcome. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJinli Ma
Fudan University
Outcome results
None listed