Phase III Study of 5tx vs 15tx of RT (X-rays or Protons) Including RNI in Breast Cancer Patients

NCT04443413 | Active Not Recruiting Phase 3

• 3 other identifiers: MC1935NCI-2020-0432819-008858
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 3

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-ray therapy is a form of radiation therapy that uses high-energy radiation from x-rays to kill tumor cells and shrink tumors. Proton beam radiation therapy is a type of radiation therapy that uses high-energy beams to treat tumors. It is not yet known what level of complications x-ray therapy or proton beam radiation therapy have in treating patients with breast cancer.

Conditions

Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Complication rate

  Will be defined as the percentage of women evaluable at 24 months who develop one or more of these events: grade 3 or higher late adverse event or unplanned surgeries for cosmetic or treatment related events, including surgeries to remove implant.

  At 24 months

Secondary Outcomes (7)

• Incidence of acute adverse events

  Up to 12 months post-radiation therapy

• Incidence of late toxicity

  Up to 5 years post-radiation therapy

• Locoregional control

  Up to 5 years post-radiation therapy

• Invasive disease-free survival

  From study registration until the time of invasive disease recurrence (not including ductal carcinoma in situ) or death due to any cause, assessed up to 5 years post-radiation therapy

• Disease-free survival

  Up to 5 years post-radiation therapy

Other Outcomes (1)

• Cosmetic outcome

  Up to 5 years post-radiation therapy

Study Arms (2)

Arm I (x-ray therapy)

EXPERIMENTAL

Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo x-ray therapy over 25 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may then receive a 4-fraction boost of x-ray therapy.

Other: Questionnaire Administration; Radiation: X-ray Therapy

Arm II (proton beam radiation therapy)

EXPERIMENTAL

Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo proton beam radiation therapy over 5 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may receive a concurrent 5-fraction boost of proton beam radiation therapy.

Radiation: Proton Beam Radiation Therapy; Other: Questionnaire Administration

Interventions

Proton Beam Radiation Therapy RADIATION

Undergo proton beam radiation therapy

Also known as: PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, PROTON Therapy, Radiation, Proton Beam, External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons)

Arm II (proton beam radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm I (x-ray therapy); Arm II (proton beam radiation therapy)

X-ray Therapy RADIATION

Undergo x-ray therapy

Also known as: X-ray Radiation Therapy

Arm I (x-ray therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Proton Therapy; Protons; X-Ray Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Carlos E. Vargas, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Panel-assessed cosmetic outcome
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: June 16, 2020
• Primary Completion (Estimated): November 19, 2026
• Study Completion (Estimated): November 19, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (3)