Phase 3
N=107
Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery
Stage I Breast Cancer AJCC v7 · Stage IA Breast Cancer AJCC v7 · Stage IB Breast Cancer AJCC v7 · Stage II Breast Cancer AJCC v6 and v7 · Stage IIA Breast Cancer AJCC v6 and v7
Bottom Line
View on ClinicalTrials.gov: NCT03324802 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor — 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hypofractionated Radiation Therapy (Radiation); Quality-of-Life Assessment (Other); Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor |
2; 3 | — |
| SECONDARY Cause-specific Survival |
100; 100 | 1.0 |
| SECONDARY Overall Survival |
100; 100 | 1.0 |
| SECONDARY Number of Patients Experiencing Distant Recurrence |
0; 0 | — |
| SECONDARY Number of Patients Experiencing Acute (Grade 3+) Adverse Events (AEs) |
1; 0 | 0.320 |
| SECONDARY Number of Patients Experiencing Grade 3+ Late Adverse Events |
1; 4 | 0.163 |
| SECONDARY Invasive Disease-free |
2.9569; 3.4743 | 0.97 |
| SECONDARY Percent of Patients With Locoregional Recurrence |
2.3; 5.8 | 0.5 |
| SECONDARY Disease-Free Survival |
2.9569; 3.17 | 0.54 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03324802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.