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Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions | Experimental | Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions |
|
| ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions | Experimental | Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy - 3 weeks | Radiation | Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment | Proportion of grade ≥ 2 of acute toxicity defined according to the Common Terminology Criteria for Adverse Events (CTCAEs) - version 5.0, on the 10-fraction arm compared to the rate on the 15-fraction arm will be measured, up to 1-month post-radiation treatment. | up to 1-month post-radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment | Assess and compare local control at 2-3 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breast clinical recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breast MRI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Formenti, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital at Lower Manhattan Cancer Center | New York | New York | 10007 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | ARM 1-4050cGY and Boost to Tumor Bed of 4800cGY in 15fractions | Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions Radiation therapy - 3 weeks: Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions |
| FG001 | ARM 2 - 3200cGY and Boost to Tumor Bed of 4200cGY -10fractions | Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. Radiation therapy - 2 weeks: Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARM 1-4050cGY and Boost to Tumor Bed of 4800cGY in 15fractions | Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions Radiation therapy - 3 weeks: Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment | Proportion of grade ≥ 2 of acute toxicity defined according to the Common Terminology Criteria for Adverse Events (CTCAEs) - version 5.0, on the 10-fraction arm compared to the rate on the 15-fraction arm will be measured, up to 1-month post-radiation treatment. | Posted | Number | proportion of participants | up to 1-month post-radiation treatment |
|
Within 1 month post radiation therapy
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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 | ARM 1-4050cGY and Boost to Tumor Bed of 4800cGY in 15fractions | Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions Radiation therapy - 3 weeks: Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Breast Hematoma evacuation | Reproductive system and breast disorders | CTCAE v5.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fabiana Gregucci | Weill Cornell Medicine | 6469623110 | fgr4002@med.cornell.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 | Dec 6, 2024 | Apr 9, 2026 | Prot_SAP_000.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 |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiation therapy - 2 weeks | Radiation | Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. |
|
| 2-3 years |
| Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment | Assess and compare local control at 5 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breasts clinical disease recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breasts MRI. | 5 years |
| Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment | Assess and compare fibrosis at 2-3 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation". | 2-3 years |
| Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment | Assess and compare breast cosmesis at 2-3 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast." | 2-3 years |
| Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment | Assess and compare fibrosis at 5 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation". | 5 years |
| Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment | Assess and compare breast cosmesis at 5 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast." | 5 years |
| Brooklyn Methodist Hospital - NewYork Presbyterian |
| New York |
| New York |
| 11215 |
| United States |
| New York Presbyterian Hospital - Queens | New York | New York | 11355 | United States |
| BG001 | ARM 2 - 3200cGY and Boost to Tumor Bed of 4200cGY -10fractions | Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. Radiation therapy - 2 weeks: Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| OG001 | ARM 2 - 3200cGY and Boost to Tumor Bed of 4200cGY -10fractions | Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. Radiation therapy - 2 weeks: Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. |
|
|
| Secondary | Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment | Assess and compare local control at 2-3 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breast clinical recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breast MRI. | Not Posted | 2-3 years | Participants |
| Secondary | Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment | Assess and compare local control at 5 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breasts clinical disease recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breasts MRI. | Not Posted | 5 years | Participants |
| Secondary | Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment | Assess and compare fibrosis at 2-3 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation". | Not Posted | 2-3 years | Participants |
| Secondary | Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment | Assess and compare breast cosmesis at 2-3 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast." | Not Posted | 2-3 years | Participants |
| Secondary | Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment | Assess and compare fibrosis at 5 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation". | Not Posted | 5 years | Participants |
| Secondary | Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment | Assess and compare breast cosmesis at 5 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast." | Not Posted | 5 years | Participants |
| 0 |
| 197 |
| 2 |
| 197 |
| 32 |
| 197 |
| EG001 | ARM 2 - 3200cGY and Boost to Tumor Bed of 4200cGY -10fractions | Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. Radiation therapy - 2 weeks: Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions. | 0 | 200 | 1 | 200 | 19 | 200 |
| Rash with itching skin reaction | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Dermatitis radiation | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Edema trunk | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| mild erythema and rash | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE v5.0 | Non-systematic Assessment |
|
| Rotator cuff injury | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Breast infection | Reproductive system and breast disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Left Breast Hematoma evacuation | Reproductive system and breast disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Seroma | Reproductive system and breast disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Rash with itching skin reaction | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |