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RECRUITING

NCT07814365

PBI for Low-risk Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: A Randomized Phase III Trial Comparing 1-Week vs. 3-Week Partial Breast Irradiation Via IMRT After Breast-Conserving Surgery for Clinical Low-Risk Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

818

Start Date

2021-09-16

Completion Date

2031-09-16

Last Updated

2026-09-11

Healthy Volunteers

Conditions

Early-Stage Breast Cancer

Interventions

RADIATION

3-week PBI

40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily

RADIATION

1-week PBI

26Gy/5Fx/1w, 5.2Gy/Fx, once daily

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China