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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Hypofractionated Radiation | Experimental | Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Hypofractionated Radiation | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 60 months |
| Number of Participants With Metastasis-free Survival |
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Inclusion Criteria:
Adult women (≥18 years old) with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology.
Patient who have undergone either a total mastectomy or a lumpectomy are eligible.
Acceptable procedures for assessment of axillary nodal status at the time of surgery include:
Eligible women include AJCC (American Joint Committee on Cancer) 7th ed. Stage cN0 or cN1 subsequently staged after surgery as Stage pIB (N1mic), pIIA, pIIB, pIIIA, pIIIB, or N3a (10 or more axillary nodes) only: note that ypN0 will also be eligible if pathologic confirmation of nodal involvement was documented prior to neoadjuvant chemotherapy and the patient was found to be node-negative at the time of surgery. Note that women less than 50 years of age, women who received chemotherapy, patients staged as pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.
The patient must have recovered from surgery with the incision completely healed and no signs of infection. If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved. The patient must have an ECOG performance status of 0 or 1 (KPS >70%).
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 180 days if chemotherapy is not delivered adjuvantly. If adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 180 days.
Before the patient is enrolled, the consent form, including any addenda, must be signed and dated by the patient and the person who explains the study to that patient.
Subjects will have the ability to understand, and the willingness to sign a written informed consent document.
Exclusion Criteria:
Note: women <50 years of age, women who received chemotherapy, pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Christine Fisher, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adjuvant Hypofractionated Radiation | Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions. Adjuvant Hypofractionated Radiation: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adjuvant Hypofractionated Radiation | Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions. Adjuvant Hypofractionated Radiation: 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. |
| 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 | 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. | Patients are included in analysis for this outcome measure if they have an event recorded for at least one of the six components of the composite endpoint, or if they had non-missing data for all six components. | Posted | Count of Participants | Participants | 12 months and 36 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 | Adjuvant Hypofractionated Radiation | Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions. Adjuvant Hypofractionated Radiation: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin infection | Infections and infestations | CTCAE v5 | Non-systematic Assessment | Cellulitis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE v 4.03 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Fisher, MD, MPH | University of Colorado, Denver | 720-848-0154 | christine.fisher@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 8, 2019 | Aug 30, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
|
| 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. | 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. | 12 months and 36 months |
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. |
| 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. | 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. | 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. | Baseline to 1 year post-intervention |
| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Patients who were missing a follow-up assessment at the given dates were excluded. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
|
| Primary | 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. | Patients who were missing a follow-up assessment at the given times for this endpoint were excluded. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
|
| Primary | 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. | Patients who were missing a follow-up assessment for this outcome measure at the given time points were excluded. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
|
| Primary | 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. | Patients were excluded if they were missing data for this event. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
|
| Primary | 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. | Patients who were missing an assessment for this endpoint were excluded. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
|
| Primary | 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. | Patients who were missing an assessment for this endpoint were excluded. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
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| Secondary | 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. | 2 subjects of 108 total were excluded due to having no follow-up data. | Posted | Count of Participants | Participants | Up to 60 months |
|
|
|
| Secondary | 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. | 2 participants who did not have a follow-up visit to assess metastasis status were excluded. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
|
| Secondary | 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. | 2 participants did not have a follow-up visit where local or regional disease recurrence was assessed and were excluded from this outcome measure. | Posted | Count of Participants | Participants | 12 months and 36 months |
|
|
|
| Secondary | 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. | This is the number of patients who completed the EORTC QLQ-C30 at both baseline and 1 year post-intervention. | Posted | Count of Participants | Participants | From baseline up to 12 months |
|
|
|
| Secondary | 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. | This is the number of patients who completed the EORTC QLQ-BR23 at both baseline and 1 year post-intervention. | Posted | Count of Participants | Participants | Baseline to 1 year post-intervention |
|
|
|
| 6 |
| 108 |
| 11 |
| 108 |
| 108 |
| 108 |
|
| Breast infection | Infections and infestations | CTCAE v 4.03 | Non-systematic Assessment |
|
| Brain mets/progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v 4.03 | Non-systematic Assessment |
|
| Death NOS | General disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE v 4.03 | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | CTCAE v 4.03 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE v 4.03 | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v 4.03 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Disease progression | General disorders | CTCAE v5 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE v 4.03 | Non-systematic Assessment | Simply recorded as pruritis. |
|
| Lymphedema | Vascular disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE v 4.03 | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v 4.03 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE v 4.03 | Non-systematic Assessment |
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| Breast tenderness | General disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v 4.03 | Non-systematic Assessment |
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| Vaginal dryness | Reproductive system and breast disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Desquamation | Skin and subcutaneous tissue disorders | CTCAE v 4.03 | Non-systematic Assessment |
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| Chest tightness | Cardiac disorders | CTCAE v 4.03 | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE v 4.03 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE v 4.03 | Non-systematic Assessment |
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