Clinical trial · Interventional
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
NCT00793962CI-TRIAL-00035236completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional fractionation radiotherapy | Radiation | — | UNRESOLVED |
| hypofractionation radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hypofractionation radiotherapy
- description
- breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
- interventionNames
- Radiation: hypofractionation radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- conventional fractionation radiotherapy
- description
- breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
- interventionNames
- Radiation: conventional fractionation radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Ipsilateral histologically confirmed invasive breast cancer * Undergone total mastectomy and axillary dissection * T3-4,or \>=4 positive axillary lymph nodes * Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation * Written,informed consent * cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy * no supraclavicular or internal mammary nodes metastases * no distant metastases * enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy. * enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy. Exclusion Criteria: * Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region * Previous or concurrent malignant other than non-melanomatous skin cancer * Unable or unwilling to give informed consent * bilateral breast cancer * immediate or delayed ipsilateral breast cancer reconstruction
References
Publications (2)
- DERIVEDYang J, Qi SN, Fang H, Song YW, Jin J, Liu YP, Wang WH, Yang Y, Tang Y, Ren H, Chen B, Lu NN, Tang Y, Li N, Jing H, Wang SL, Li YX. Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer. Breast. 2021 Aug;58:72-79. doi: 10.1016/j.breast.2021.04.002. Epub 2021 Apr 19. PMID 33933925
- DERIVEDWang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30. PMID 30711522