Clinical trial NCT03324802: Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery
Official title: A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIA Breast Cancer AJCC v7
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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.

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

Primary outcomes:
measure: 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
timeFrame: 24 months
Secondary outcomes:
measure: Cause-specific Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
measure: Number of Patients Experiencing Distant Recurrence
timeFrame: 5 years
measure: Number of Patients Experiencing Acute (Grade 3+) Adverse Events (AEs)
timeFrame: 3 months
measure: Number of Patients Experiencing Grade 3+ Late Adverse Events
timeFrame: 24 months
measure: Invasive Disease-free
timeFrame: 5 years
measure: Percent of Patients With Locoregional Recurrence
timeFrame: 5 years
measure: Disease-Free Survival
timeFrame: 5 years
Other outcomes:
measure: Patient Reported Outcomes/Quality of Life
timeFrame: Up to 5 years
measure: Patient Reported Outcomes/Quality of Life
timeFrame: Up to 5 years
measure: Patient Self-reported Cosmesis
timeFrame: Baseline up to 5 years
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carlos Vargas
role: PRINCIPAL_INVESTIGATOR
References: