| Primary | 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 | The complication rate will be reported by arm. | | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Cause-specific Survival | Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for one year with 95% CIs. Comparison between arms will employ a log-rank test. | | Posted | | Number | 95% Confidence Interval | percentage of patients | | 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Overall Survival | Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for one year along with 95% CIs. Comparison between arms will employ a log-rank test. | | Posted | | Number | 95% Confidence Interval | percentage of patients | | 1 year | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Number of Patients Experiencing Distant Recurrence | Distant recurrence defined as metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Number of Patients Experiencing Acute (Grade 3+) Adverse Events (AEs) | The maximum grade for each type of acute (grade 3+) AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. The relationship of the adverse event(s) to the study treatment will be taken into consideration. Number of patients experiencing one or more grade 3+ events will be compared between arms using chi-squared tests. Adverse events were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | | Posted | | Count of Participants | | Participants | | 3 months | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Number of Patients Experiencing Grade 3+ Late Adverse Events | The maximum grade for each type of late AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. The relationship of the adverse event(s) to the study treatment will be taken into consideration. Number of patients experiencing one or more grade 3+ late AEs will be compared between arms using chi-squared tests. | | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Invasive Disease-free | Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Median invasive disease-free time will be given along with standard error. Comparison between arms will employ a log-rank test. | | Posted | | Median | Standard Error | years | | 5 years | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Percent of Patients With Locoregional Recurrence | The cumulative incidence of locoregional recurrence will be estimated using a competing risks method by treatment arm. The competing risks will be distant breast cancer recurrence and death. Comparison between arms will employ Fine-Gray regression. Locoregional recurrence is clinically diagnosed invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast at 5 years. | | Posted | | Number | 95% Confidence Interval | percentage of patients | | 5 years | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Secondary | Disease-Free Survival | Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Median disease free survival time and standard error will be estimated. Comparison between arms will employ a log-rank test. | | Posted | | Median | Standard Error | years | | 5 years | | | | ID | Title | Description |
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| OG000 | Arm 1 (Radiation Therapy, 15 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy | | OG001 | Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) | Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
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| Other Pre-specified | Patient Reported Outcomes/Quality of Life | The subscales of the Breast Cancer Treatment Outcomes Scale (BCTOS), elements from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and other patient reported measures such as fatigue, breast pain, breast shape, and arm related morbidity outlined in the appendix will be summarized as the mean +/- standard deviation and median (minimum value, maximum value). Mixed models will be used to estimate changes at fixed time points. | | Not Posted | | | | | | Up to 5 years | | Participants | | | | |
| Other Pre-specified | Patient Reported Outcomes/Quality of Life | The subscales of the Breast Cancer Treatment Outcomes Scale (BCTOS), elements from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and other patient reported measures such as fatigue, breast pain, breast shape, and arm related morbidity outlined in the appendix will be summarized as the mean +/- standard deviation and median (minimum value, maximum value). Mixed models will be used to compare outcomes between arms. | | Not Posted | | | | | | Up to 5 years | | Participants | | | | |
| Other Pre-specified | Patient Self-reported Cosmesis | Will evaluate fatigue, breast pain, arm function. The values of the cosmesis instruments (patient self-reported and panel-assessed) will be summarized with the frequencies and confidence intervals of fair or poor cosmesis events at baseline, 2 years, and 5 years by treatment arm. Comparisons between arms will employ chi-squared tests. | | Not Posted | | | | | | Baseline up to 5 years | | Participants | | | | |