Breast Cancer Clinical Trial

Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery

Summary

This randomized phase II 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.

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Full 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 OBJECTIVES:

I. To evaluate acute and late toxicity. II. To estimate the 5-year locoregional control, invasive disease-free survival and overall survival.

TERTIARY OBJECTIVES:

I. To evaluate fatigue, and other patient-reported outcomes. II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with fair and poor cosmetic outcomes or unplanned surgical intervention.

III. To evaluate the costs and comparative effectiveness of treatment. IV. Compare the use of photon therapy with spot scanning proton therapy in two different hypo-fractionated whole breast schemas.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo radiation therapy in 15 daily fractions for 10 days.

ARM II: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days.

After completion of study treatment, patients are followed up to 5 years.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT03324802

Recruitment Status:

Active, not recruiting

Sponsor:

Mayo Clinic

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There are 3 Locations for this study

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Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
Mayo Clinic
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT03324802

Recruitment Status:

Active, not recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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