| ID | Type | Description | Link |
|---|---|---|---|
| MC1631 | Other Identifier | Mayo Clinic | |
| NCI-2017-02362 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This is a randomized controlled trial to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Fractionation | No Intervention | 50.0 Gy (RBE) in 25 daily fractions | |
| Hypofractionation | Experimental | 40 Gy (RBE) in 15 daily fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionation | Radiation | 40 Gy (RBE) in 15 daily fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Will be defined as the percentage of women randomized who develop one or more of the following events: grade 3 or higher late adverse events; unplanned surgical intervention (not including planned serial fat grafting) in patients who undergo mastectomy with reconstruction. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Adverse Events | Acute adverse events are defined using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 1 or 2 events occurring in at least 10% of patients are reported along with all grade 3 or higher events. | 5 years |
| Incidence of Late Adverse Events |
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Inclusion Criteria
Note: Breast implants and expanders allowed
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert W. Mutter, 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 Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37696281 | Derived | Mutter RW, Giri S, Fruth BF, Remmes NB, Boughey JC, Harless CA, Ruddy KJ, McGee LA, Afzal A, Gao RW, Shumway DA, Vern-Gross TZ, Villarraga HR, Kenison SL, Kang Y, Wong WW, Stish BJ, Merrell KW, Yan ES, Park SS, Corbin KS, Vargas CE. Conventional versus hypofractionated postmastectomy proton radiotherapy in the USA (MC1631): a randomised phase 2 trial. Lancet Oncol. 2023 Oct;24(10):1083-1093. doi: 10.1016/S1470-2045(23)00388-1. Epub 2023 Sep 8. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Fractionation | 50.0 Gy (RBE) in 25 daily fractions |
| FG001 | Hypofractionation | 40 Gy (RBE) in 15 daily fractions> Hypofractionation: 40 Gy (RBE) in 15 daily fractions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Fractionation | 50.0 Gy (RBE) in 25 daily fractions |
| BG001 | Hypofractionation | 40 Gy (RBE) in 15 daily fractions> Hypofractionation: 40 Gy (RBE) in 15 daily fractions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Complication Rate | Will be defined as the percentage of women randomized who develop one or more of the following events: grade 3 or higher late adverse events; unplanned surgical intervention (not including planned serial fat grafting) in patients who undergo mastectomy with reconstruction. | All treated patients were included in this analysis. | Posted | Number | percentage of participants | 24 months |
|
5 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 | Conventional Fractionation | 50.0 Gy (RBE) in 25 daily fractions | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Telangiestasia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Mutter, M.D. | Mayo Clinic | 507-284-2511 | mutter.robert@mayo.edu |
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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 5, 2024 | Aug 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2018 | Sep 16, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Late adverse events are defined using CTCAE version 4. Grade 1 or 2 events occurring in at least 10% of patients are reported along with all grade 3 or higher events. |
| 5 years |
| Reconstruction Failure | A failure is defined as loss of the tissue expander or implant with the inability to replace it resulting in no final reconstruction or conversion to autologous reconstruction or revised with the addition of autologous reconstruction. | 5 years |
| Quality of Life - Breast Cancer Outcomes | measured by cosmesis evaluation and the Breast Cancer Treatment Outcome Scale (BCTOS) | 5 years |
| Cosmesis | measured by reviewing digital photographs and the 4 point (excellent, good, fair, poor) adaptation of the Harvard Cosmesis Scale | baseline, 2 years, and 5 years |
| Ipsilateral Breast Tumor Recurrence (IBTR) Incidence | Will be defined as local recurrence from trial registration as a first event at 5 years. The IBTR cumulative incidence will be estimated using a competing risks method by treatment arm. The competing risks will be regional/distant breast cancer recurrence and death. The percentage of patients with IBTR is defined as the number of patients that have a IBTR divided by the number of patients treated in each arm. | 5 years |
| Distant Recurrence Incidence | Will assess metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer at 5 years. The percentage of patients with a distant recurrence is defined as the number of patients that have a distant recurrence divided by the number of patients treated in each arm. | 5 years |
| Regional Recurrence Incidence | Defined as invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast at 5 years. The percentage of patients with a regional recurrence is defined as the number of patients that have a regional recurrence divided by the number of patients treated in each arm. | 5 years |
| Disease-free Survival (DFS) at 3 Years | DFS is defined as the time from study registration until the occurrence, if any, of one of the following events: invasive IBTR, regional invasive breast cancer recurrence, distant breast cancer recurrence, death due to any cause, contralateral invasive breast cancer, and second primary non-breast invasive disease. DFS at 3 years will be reported as the percent of patients without a DFS event at 3 years post radiotherapy. | 3 years post radiotherapy, up to 38 months |
| Overall Survival (OS) at 3 Years | Overall survival is defined as the time from registration to death due to any cause. OS at 3 years is reported as the percentage of patients still alive and in follow up at 3 years post radiotherapy. | 3 years post radiotherapy, up to 38 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Incidence of Acute Adverse Events | Acute adverse events are defined using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 1 or 2 events occurring in at least 10% of patients are reported along with all grade 3 or higher events. | Posted | Number | event occurrence | 5 years |
|
|
|
| Secondary | Incidence of Late Adverse Events | Late adverse events are defined using CTCAE version 4. Grade 1 or 2 events occurring in at least 10% of patients are reported along with all grade 3 or higher events. | All patients that were evaluated for adverse events 90 or more days after radiotherapy. | Posted | Number | event occurrence | 5 years |
|
|
|
| Secondary | Reconstruction Failure | A failure is defined as loss of the tissue expander or implant with the inability to replace it resulting in no final reconstruction or conversion to autologous reconstruction or revised with the addition of autologous reconstruction. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Quality of Life - Breast Cancer Outcomes | measured by cosmesis evaluation and the Breast Cancer Treatment Outcome Scale (BCTOS) | Not Posted | Jan 2026 | 5 years | Participants |
| Secondary | Cosmesis | measured by reviewing digital photographs and the 4 point (excellent, good, fair, poor) adaptation of the Harvard Cosmesis Scale | Not Posted | baseline, 2 years, and 5 years | Participants |
| Secondary | Ipsilateral Breast Tumor Recurrence (IBTR) Incidence | Will be defined as local recurrence from trial registration as a first event at 5 years. The IBTR cumulative incidence will be estimated using a competing risks method by treatment arm. The competing risks will be regional/distant breast cancer recurrence and death. The percentage of patients with IBTR is defined as the number of patients that have a IBTR divided by the number of patients treated in each arm. | Posted | Number | percentage of patients | 5 years |
|
|
|
| Secondary | Distant Recurrence Incidence | Will assess metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer at 5 years. The percentage of patients with a distant recurrence is defined as the number of patients that have a distant recurrence divided by the number of patients treated in each arm. | Posted | Number | percentage of patients | 5 years |
|
|
|
| Secondary | Regional Recurrence Incidence | Defined as invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast at 5 years. The percentage of patients with a regional recurrence is defined as the number of patients that have a regional recurrence divided by the number of patients treated in each arm. | Posted | Number | percentage of patients | 5 years |
|
|
|
| Secondary | Disease-free Survival (DFS) at 3 Years | DFS is defined as the time from study registration until the occurrence, if any, of one of the following events: invasive IBTR, regional invasive breast cancer recurrence, distant breast cancer recurrence, death due to any cause, contralateral invasive breast cancer, and second primary non-breast invasive disease. DFS at 3 years will be reported as the percent of patients without a DFS event at 3 years post radiotherapy. | Posted | Number | 95% Confidence Interval | percentage of patients | 3 years post radiotherapy, up to 38 months |
|
|
|
| Secondary | Overall Survival (OS) at 3 Years | Overall survival is defined as the time from registration to death due to any cause. OS at 3 years is reported as the percentage of patients still alive and in follow up at 3 years post radiotherapy. | Posted | Number | 95% Confidence Interval | percentage of patients | 3 years post radiotherapy, up to 38 months |
|
|
|
| 44 |
| 2 |
| 44 |
| 41 |
| 44 |
| EG001 | Hypofractionation | Hypofractionation: 40 Gy (RBE) in 15 daily fractions | 2 | 44 | 3 | 44 | 41 | 44 |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12 | Systematic Assessment |
|
| Breast infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
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| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Brachial plexopathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Lymphedema | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Breast oedema |
|
| Skin hyperpigmentation |
|
| Oedema of the limbs |
|
| Radiation dermatitis |
|
| Stroke |
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| Non-cardiac chest pain |
|
| Joint range of motion decreased |
|
| Skin hyperpigmentation |
|
| Joint range of motion decreased |
|
| Oedema of the limbs |
|
| Radiation dermatitis |
|
| Non-cardiac chest pain |
|
| Superficial soft tissue fibrosis |
|
| Fibrosis deep connective tissue |
|