Status:
COMPLETED
Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery
Lead Sponsor:
Mayo Clinic
Conditions:
Stage I Breast Cancer AJCC v7
Stage IA Breast Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 radiatio...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the 24-month complication rate of 5 fraction whole radiotherapy +/- concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost. SECONDARY OBJEC...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03324802
Start Date
February 7 2018
End Date
August 28 2023
Last Update
May 2 2024
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
3
Mayo Clinic
Rochester, Minnesota, United States, 55905