The proposed study is being done to learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer. Subjects are being asked to be in this research study because they have already had surgery for breast cancer and some cancer cells were found in their lymph nodes that drain the breast tissue.
Subjects who join the study will receive a shortened course of radiation treatment that will last approximately four (4) weeks, instead of the traditional six (6) week course that women have typically received in this situation. The shorter course subjects will receive is designed in a way that it is thought to be equivalent to the longer course. This shorter course has already been shown to be very safe and effective when treating breast cancer in the breast tissue only. However, because cancer cells were found in the lymph nodes that drain their breast, subjects require radiation to a larger area of their chest, armpit, and shoulder than has been completely tested with this experimental dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
University of Colorado Hospital
Aurora, Colorado, United States
Memorial Hospital
Colorado Springs, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Number of Participants With at Least One Treatment-related Adverse Event of Interest
The composite endpoint is "yes" for a given patient if that patient experienced at least one of six component adverse events: lymphedema, shoulder ROM impairment, cardiac ischemia, symptomatic rib fracture, brachial plexopathy Grade 2 ('moderate symptoms; limiting instrumental activity of daily living (ADL)') or Grade 3 ('severe symptoms; limiting self-care ADL'), or Grade 2 pneumonitis (requires steroids). AEs were assessed by CTCAE version 4.03.
Time frame: 12 months and 36 months
Number of Participants With Lymphedema Severity by Measuring Interlimb Circumference
An increase in interlimb arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same timepoint, will be judged to be clinically significant lymphedema. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be assessed at 12 months and at 36 months.
Time frame: 12 months and 36 months
Number of Participants With Symptomatic Rib Fracture as Measured by Plain Film or CT
Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT.
Time frame: 12 months and 36 months
Number of Participants With New Development of Ischemic Heart Disease as Measured by EKG
Ischemic heart disease will be measured by the new development of angina with corresponding EKG changes, or myocardial infraction.
Time frame: 12 months and 36 months
Number of Participants Reporting Shoulder Stiffness as Measured by the EORTC QLQ-BR23
Shoulder stiffness severity is assessed using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire breast cancer module (EORTC QLQ-BR23). It is assessed based on patient response to the questionnaire item, "During the past week, was it difficult to raise your arm or to move it sideways?", which is scored from 1 to 4 with 1 being "not at all" and 4 being "very much". Shoulder stiffness is identified in a patient when their response to that question is 3 or 4 AND if their response increased numerically from their response on day 1.
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Time frame: 12 months and 36 months
Number of Participants With Grade 2 or Higher Pneumonitis
Number of patients who experience pneumonitis as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
Time frame: 12 months and 36 months
Number of Participants With Grade 2 or Higher Brachial Plexopathy
Number of patients who experience brachial plexopathy as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.
Time frame: 12 months and 36 months
Number of Participants With Disease Recurrence
Recurrent disease presentation within axillary lymph node levels I, II, or III. The supraclavicular region is not included in this endpoint.
Time frame: Up to 60 months
Number of Participants With Metastasis-free Survival
Measured by the time from date of enrollment to earlier of clinical detection of metastatic disease beyond the breast/chestwall and regional lymph nodes or death.
Time frame: 12 months and 36 months
Number of Participants With Local-regional Failure Free Survival
Measured by the time from date of enrollment to earlier of clinical detection of any ipsilateral recurrent disease to the breast/chestwall or regional lymph nodes (levels I, II, III, supraclavicular, and internal mammary lymph nodes) or death.
Time frame: 12 months and 36 months
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-C30
Patient's quality of life from pre-treatment to post-treatment, reported by the quality of life questionnaire \[EORTC QLQ-C30 V1\]. Summary scores and missing data handling were performed according to the EORTC QLQ-C30. The minimum score is 0, and the maximum score is 100. A higher score is a better outcome. A change in score is defined as a score increase of at least 10 points at the 12 month mark compared to baseline.
Time frame: From baseline up to 12 months
Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-BR23
Patient's quality of life from pre-treatment to post-treatment, reported by the quality of life questionnaire breast cancer module \[EORTC QLQ-BR23 V1\]. Summary scores and missing data handling were performed according to the EORTC QLQ-BR23. The minimum score is 0, and the maximum score is 100. A higher score is a better outcome. A change in score is defined as a score increase of at least 10 points from baseline.
Time frame: Baseline to 1 year post-intervention