Status:
ACTIVE_NOT_RECRUITING
Phase III Study of 5tx vs 15tx of RT (X-rays or Protons) Including RNI in Breast Cancer Patients
Lead Sponsor:
Mayo Clinic
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This phase III trial compares the rate of complications of x-ray therapy versus proton beam radiation therapy after breast conserving surgery or mastectomy in treating patients with breast cancer. X-r...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the 24-month complication rate of 5 fraction radiotherapy compared to 25 fraction radiotherapy. SECONDARY OBJECTIVES: I. To evaluate acute toxicity that occur up ...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Histological confirmation of breast cancer
- Breast conserving surgery or mastectomy (reconstruction is allowed)
- Clinical or pathologic T1-T4c, N0-3, M0 disease
- 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
- Indications for breast or post mastectomy radiation with regional nodal radiotherapy per the discretion of the treating physician
- If uncertain of eligibility please consult the principal investigator (PI)
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 or PI, 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
- Prior receipt of ipsilateral breast or chest wall radiation
- Persistent positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer
- No active metastatic disease from other origin
- Recurrent breast cancer
- Patient requires bilateral breast radiation treatment
- cT4d patients (inflammatory breast cancer)
- Patients that may not be compliant or fit for the study at the discretion of the PI
- Male patients
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2029
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04443413
Start Date
June 16 2020
End Date
November 19 2029
Last Update
August 13 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905