Clinical trial · Interventional
Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery
Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hypofractionation radiotherapy
- description
- irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.
- interventionNames
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- conventional fractionation radiotherapy
- description
- irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
- interventionNames
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- in-breast recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. KPS\>=60 2. histology confirmed invasive breast cancer 3. received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative) 4. surgical margins negative 5. primary tumor ≤5cm in the largest diameter 6. no internal mammary node or supraclavicular node metastases or distant metastasis 7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy 8. for patients not need chemotherapy,enrollment date is required no more than 8 weeks from surgery date 9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy 10. patients signed written inform consent form Exclusion Criteria: 1. ductal carcinoma in situ 2. prior neoadjuvant chemotherapy 3. prior breast cancer history 4. bilateral breast cancer 5. pregnant or during lactation 6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ 7. active collagen vascular disease 8. prior neoadjuvant hormone therapy 9. immediate ipsilateral breast reconstruction
References
Publications (1)
- DERIVEDWang SL, Fang H, Hu C, Song YW, Wang WH, Jin J, Liu YP, Ren H, Liu J, Li GF, Du XH, Tang Y, Jing H, Ma YC, Huang Z, Chen B, Tang Y, Li N, Lu NN, Qi SN, Yang Y, Sun GY, Liu XF, Li YX. Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China. J Clin Oncol. 2020 Nov 1;38(31):3604-3614. doi: 10.1200/JCO.20.01024. Epub 2020 Aug 11. PMID 32780661