A Phase 3 interventional study of Ultrafractionated Radiotherapy and Moderately Hypofractionated Radiotherapy in Breast Cancer and Radiotherapy, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
This phase III, multicenter, prospective, randomized controlled trial evaluates whether ultrafractionated radiotherapy (26Gy/5Fx) is non-inferior to moderate hypofractionated radiotherapy (40Gy/15Fx) in terms of local-regional recurrence for breast cancer patients after curative surgery (breast-conserving surgery or mastectomy). A total of 2,872 patients will be enrolled from 14 Chinese centers. Participants will be stratified by surgery type, lymph node status, TNBC subtype, and neoadjuvant chemotherapy status. The primary endpoint is local-regional recurrence rate; secondary endpoints include overall survival, disease-free survival, distant metastases, breast cancer-specific survival, toxicity, cosmetic outcomes, and quality of life. This study will provide high-level evidence on whether a 5-fraction ultra-hypofractionated regimen can safely replace the standard 15-fraction moderately hypofractionated regimen in the post-operative setting.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 2,872 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Age ≥ 18 years, female or male. 2. confirmed invasive breast carcinoma. 3. Underwent curative-intent breast cancer surgery, including total mastectomy or breast-conserving surgery, with microscopically negative margins (ink-negative margins).
4. Axillary staging performed by sentinel lymph node (SLNB) or axillary lymph node dissection (ALND).
5. For patients undergoing breast-conserving surgery:
If neoadjuvant chemotherapy was received: clinical stage T1-3N0-2 and pathological stage T0-3N0-3a (excluding N2b).
6. For patients undergoing total mastectomy:
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With neoadjuvant chemotherapy: clinical stage T3N0, or T1-3N1-2, and pathological stage T0-3N0-3a (excluding N2b).
7. No evidence of disease. 8. performance status 0-1.
Exclusion Criteria:
1. Initial pathological diagnosis of ductal carcinoma in situ (DCIS) without invasive carcinoma.
2. T4 breast cancer, including inflammatory breast cancer. 3. Clinical or pathological stage with confirmed positive supraclavicular, infraclavicular, or internal mammary lymph nodes, or radiologically suspicious nodes considered to require boost irradiation.
4. Patients who have undergone implant-based breast reconstruction, including prosthetic reconstruction or tissue expander placement.
5. Known BRCA mutation carriers (testing is not required but if known, patients are excluded).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
26Gy in 5 fractions to the breast/chest wall with or without regional nodal irradiation. For breast-conserving surgery patients, a simultaneous integrated boost (SIB) of 31Gy in 5 fractions is delivered to the tumor bed.
Radiation: Ultrafractionated Radiotherapy
40Gy in 15 fractions to the breast/chest wall with or without regional nodal irradiation. For breast-conserving surgery patients, a simultaneous integrated boost (SIB) of 48Gy in 15 fractions is delivered to the tumor bed.
Radiation: Moderately Hypofractionated Radiotherapy
26Gy in 5 fractions (5.2Gy per fraction) to the breast/chest wall; SIB of 31Gy in 5 fractions (6.2Gy per fraction) for tumor bed after breast-conserving surgery. Regional nodal irradiation is permitted per protocol criteria.
Moderately hypofractionated radiotherapy delivered to the breast/chest wall with or without regional nodal irradiation. The total dose is 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks. For patients undergoing breast-conserving surgery, a simultaneous integrated boost (SIB) of 48 Gy in 15 fractions (3.2 Gy per fraction) is delivered to the tumor bed. Regional nodal irradiation includes internal mammary nodes (IMN), supraclavicular nodes (SCN), and/or level I-II axillary nodes (ALN) as clinically indicated per protocol.
Local-Regional Recurrence (LRR)
Time from randomization to the first event of ipsilateral breast, chest wall, supraclavicular, axillary, or internal mammary nodal recurrence.
Time frame: 5 years
Acute and Late Toxicities
Assessment of radiation-related toxicities, including shoulder joint dysfunction, upper limb edema, shoulder pain, acute radiation skin reaction, radiation esophagitis, cardiovascular events (myocardial infarction, heart failure, acute coronary syndrome, valvular disease), radiation pneumonitis and pulmonary fibrosis, hypothyroidism, and brachial plexus injury.
Time frame: 5 years
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: 5 years
Disease-Free Survival (DFS)
Time from randomization to the first event of local-regional recurrence, distant recurrence, death from any cause, contralateral breast cancer, or second primary cancer.
Time frame: 5 years
Distant Metastasis-Free Survival (DMFS)
Time from randomization to the first event of recurrence at any site other than local-regional.
Time frame: 5 years
Breast Cancer-Specific Survival (BCSS)
Time from randomization to death due to breast cancer. Deaths from causes other than breast cancer will be handled according to the prespecified statistical analysis plan.
Time frame: 5 years
EORTC Quality of Life Questionnaire (EORTC-QLQ-C30; version 3)
Assessment of treatment-related symptoms, health-related quality of life via the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30; version 3)
Time frame: 5 years
breast cancer module (QLQ-BR23)
Assessment of treatment-related symptoms, health-related quality of life via questionnaire breast cancer module (QLQ-BR23)
Time frame: 5 years
the Quick Disabilities of the Arm, Shoulder and Hand (q-DASH) questionnaire.
Assessment of upper limb function via the Quick Disabilities of the Arm, Shoulder and Hand (q-DASH) questionnaire.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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