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| ID | Type | Description | Link |
|---|---|---|---|
| 17-004130 | Other Identifier | Mayo Clinic Institutional Review Board |
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This phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before 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.
PRIMARY OBJECTIVES:
I. To determine the pathologic complete response (pCR) rate after hypofractionated radiotherapy to the whole breast alone, based on the postsurgical specimen.
SECONDARY OBJECTIVES:
I. To evaluate acute and late toxicity with preoperative radiation including grade >= 2 pneumonitis.
II. To estimate the 5-year locoregional control, distant recurrence, invasive disease-free survival, cause-specific survival, and overall survival.
CORRELATIVE AND EXPLORATORY OBJECTIVES:
I. To evaluate patient-reported outcomes. II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention.
III. Evaluate tumor mutation signatures before and after radiation; correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery.
IV. To describe the pathologic changes seen in breast cancer patients with preoperative radiation.
OUTLINE:
Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.
After completion of study treatment, participants are followed up at 12 weeks, 6, 12, 24, and 36 months, and 5 years after radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (hypofractionated radiation therapy) | Experimental | Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | Undergo hypofractionated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen | The proportion of successes (number of patients achieving pCR at time of definitive surgery) will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Adverse Events (AE) | The maximum grade for each type of acute AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. | Up to 180 days post radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Self-reporting of Toxicities | 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 +/- SD and median (minimum value, maximum value). Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Analysis will include percent change from baseline using t-tests and generalized linear models to test for changes at each time point and non-zero slope respectfully. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos E. Vargas, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Hypofractionated Radiation Therapy) | Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.>> >> Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2022 |
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| Incidence of 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. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. | Up to 5 years post radiation therapy |
| Locoregional Control | The cumulative incidence of locoregional recurrence will be estimated using a competing risks method (Gooley et al.). The competing risks will be distant breast cancer recurrence and death. | Up to 5 years |
| Invasive Disease-free Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% confidence intervals (CIs). | From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years |
| Distant Recurrence | Up to 5 years |
| Disease- Free Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years |
| Cause-specific Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | From registration to death due to breast cancer assessed up to 5 years |
| Overall Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | From registration to death due to any cause assessed up to 5 years |
| Up to 5 years |
| Patient Self-reported Cosmetic Outcomes | Assessed using a modified Harvard Cosmesis Scale and the BCTOS. 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. | Baseline up to 5 years |
| Panel Assessed Cosmetic Outcome | Cosmesis will be assessed by a panel of breast cancer medical providers using digital photographs. | Baseline up to 2 years |
| Clinical Features, Treatment Technique, Dose-volume Parameters, Histologic and Genetic Variants | Associated with adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention. | Up to 5 years |
| Tumor Mutation Signatures | Will be analyzed before and after radiotherapy as compared to pathologic information at the time of surgery. Continuous variable will be compared using unpaired t tests and nominal variables will be compared using contingency tables and Chi square analyses. | Up to 5 years |
| Pathologic Changes Seen in Breast Cancer Patients With Preoperative Radiation | Will be described. | Up to 5 years |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Hypofractionated Radiation Therapy) | Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.>> >> Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Enrollment Site | Count of Participants | Participants |
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| Method of Payment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen | The proportion of successes (number of patients achieving pCR at time of definitive surgery) will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. | If more than the target number of 22 patients are accrued, the additional patients will not be used to evaluate the stopping rule or used in any decision making process. | Posted | Number | proportion of participants | up to 2 years |
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| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Acute Adverse Events (AE) | The maximum grade for each type of acute AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. | Posted | Count of Participants | Participants | Up to 180 days post radiation therapy |
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| ||||||||||||||||||||||||||||
| Secondary | Incidence of 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. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. | Not Posted | Up to 5 years post radiation therapy | Participants | |||||||||||||||||||||||||||||||
| Secondary | Locoregional Control | The cumulative incidence of locoregional recurrence will be estimated using a competing risks method (Gooley et al.). The competing risks will be distant breast cancer recurrence and death. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Secondary | Invasive Disease-free Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% confidence intervals (CIs). | Not Posted | From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Secondary | Distant Recurrence | Not Posted | Up to 5 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Disease- Free Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | Not Posted | From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Secondary | Cause-specific Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | Not Posted | From registration to death due to breast cancer assessed up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | Not Posted | From registration to death due to any cause assessed up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Patient Self-reporting of Toxicities | 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 +/- SD and median (minimum value, maximum value). Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Analysis will include percent change from baseline using t-tests and generalized linear models to test for changes at each time point and non-zero slope respectfully. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Patient Self-reported Cosmetic Outcomes | Assessed using a modified Harvard Cosmesis Scale and the BCTOS. 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. | Not Posted | Baseline up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Panel Assessed Cosmetic Outcome | Cosmesis will be assessed by a panel of breast cancer medical providers using digital photographs. | Not Posted | Baseline up to 2 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Clinical Features, Treatment Technique, Dose-volume Parameters, Histologic and Genetic Variants | Associated with adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Tumor Mutation Signatures | Will be analyzed before and after radiotherapy as compared to pathologic information at the time of surgery. Continuous variable will be compared using unpaired t tests and nominal variables will be compared using contingency tables and Chi square analyses. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Pathologic Changes Seen in Breast Cancer Patients With Preoperative Radiation | Will be described. | Not Posted | Up to 5 years | Participants |
up to 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Hypofractionated Radiation Therapy) | Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy | 2 | 24 | 2 | 24 | 22 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Resp, thoracic, mediastinal - Oth spec | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 15 | Systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
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| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
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| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| Lymphedema | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Vargas | Mayo Clinic | 480-342-1267 | Vargas.Carlos@mayo.edu |
| Sep 21, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2020 | Jan 22, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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