Clinical trial · Interventional
Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery
A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery
NCT03324802CI-TRIAL-00076701completedPhase 3Results postedClinicalTrials.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)
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIB Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage II Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 2 (hypofractionated radiation therapy, 5 fractions)
- description
- Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm I (radiation therapy, 15 fractions)
- description
- Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days.
- interventionNames
- Other: Quality-of-Life Assessment
- Radiation: Radiation Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of breast cancer * Pathologic stage T0-T3N0-N1M0 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 * Able to and provides Institutional Review Board (IRB) approved study specific written informed consent * Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable) * Able to complete all mandatory tests * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale * Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy * Breast conserving surgery and indications for whole breast radiotherapy Exclusion Criteria: * Medical contraindication to receipt of radiotherapy * Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent * Active systemic lupus or scleroderma * Pregnancy * Prior receipt of ipsilateral breast or chest wall radiation * Positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer * History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry * Recurrent breast cancer * Indications for comprehensive regional nodal irradiation
References
Publications (1)
- DERIVEDLaughlin BS, Corbin KS, Toesca DAS, Thorpe CS, Golafshar MA, Pockaj B, Cronin P, McGee LA, Halyard MY, Mutter RW, Keole SR, Park SS, Shumway DA, Vern-Gross TZ, Vallow L, Wong WW, DeWees TA, Vargas CE. Physician- and Patient-Reported Outcomes of the MC1635 Phase 3 Trial of Ultrahypofractionated Versus Moderately Hypofractionated Adjuvant Radiation Therapy After Breast-Conserving Surgery. Int J Radiat Oncol Biol Phys. 2024 Mar 15;118(4):1049-1059. doi: 10.1016/j.ijrobp.2023.10.018. Epub 2023 Oct 31. PMID 37914139