Clinical trial · Interventional
Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
A Prospective Phase 3 Clinical Trial Of Postmastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
NCT03319069CI-TRIAL-00030027unknownPhase 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 hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastectomy. It's 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 fractionated radiotherapy | Radiation | — | UNRESOLVED |
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- group (1)
- description
- Hypofractionated radiotherapy women with T3-4 and /or 4 or more axillary nodes involvement post mastectomy. Hypofractionated radiotherapy 43,5 GY/15 fractions (f) /3w. to chest wall and supraclavicular nodal region.
- interventionNames
- Radiation: Hypofractionated radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- group(2)
- description
- Conventional fractionated radiotherapy breast cancer women with T3-4 and/ or 4 or more axillary nodes involvement post mastectomy. Conventional fractionated radiotherapy 50 Gray(GY)/25 fractions (f)/5w to chest wall and supraclavicular nodal region.
- interventionNames
- Radiation: Conventional fractionated radiotherapy
Primary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer * Undergone total mastectomy and axillary dissection T 3-4 and/or 4 or more positive axillary lymph nodes. * Fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation. * Written informed concent. * C T3-4 , or C N2, 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 did't receive neoadjuvant therapy. * Enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did'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 * Bilateral breast cancer. * Immediate or delayed ipsilateral breast cancer reconstruction.
References
Publications (0)
Data not yet available
No reference posted for this study.