Comparing Ultrafractionated and Moderate Hypofractionated Radiotherapy for Post-Surgery Breast Cancer

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 3

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

2872 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 1\. Age ≥ 18 years, female or male. 2. Histologically 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 biopsy (SLNB) or axillary lymph node dissection (ALND).

5\. For patients undergoing breast-conserving surgery:
1. Negative surgical margins (ink-negative margins).
2. Meets indications for tumor bed boost: ipsilateral multifocal disease is permitted; patients at low risk who may be exempt from boost are excluded: age ≥ 50 years, T1N0, histological grade I-II, ER-positive.
3. If primary surgery without neoadjuvant chemotherapy: pathological stage T1-3N0-3a (excluding N2b).
4. 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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1. Has indications for local ± regional radiotherapy.
2. Without neoadjuvant chemotherapy: pathological stage T3N0, or T1-3 N1-3a (excluding N2b).
3. With neoadjuvant chemotherapy: clinical stage T3N0, or T1-3N1-2, and pathological stage T0-3N0-3a (excluding N2b).

7\. No evidence of metastatic disease. 8. ECOG 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 pathologically 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).

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Fudan University

Study start

Aug 1, 2026 Actual

Primary completion

2033-08 Estimated

Study completion

2036-07 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.