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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Boston Medical Center |
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The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irradiation using 32 Gy / 8 fractions | Experimental | Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week |
|
| Irradiation using 36 Gy / 9 fractions | Experimental | Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week |
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| Irradiation using 40 Gy / 10 fractions | Experimental | Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial Breast Irradiation using 32 Gy / 8 fractions | Radiation | 32 Gy-8 Treatments, 4 Treatment Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion. | Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility. | 10 years |
| Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy | Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint | Number of patients who presented with moderate to severe composite toxicity as an endpoint | 8 years |
| Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alphonse Taghian, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22652104 | Derived | Pashtan IM, Recht A, Ancukiewicz M, Brachtel E, Abi-Raad RF, D'Alessandro HA, Levy A, Wo JY, Hirsch AE, Kachnic LA, Goldberg S, Specht M, Gadd M, Smith BL, Powell SN, Taghian AG. External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e271-7. doi: 10.1016/j.ijrobp.2012.04.019. Epub 2012 May 30. | |
| 19620489 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Irradiation Using 32 Gy / 8 Fractions | Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days |
| 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 | Apr 3, 2012 |
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| OTHER |
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|
| Partial Breast Irradiation using 36 Gy / 9 fractions | Radiation | 36 Gy- 9 Treatments, 4 1/2 Treatment Days |
|
|
| Partial Breast Irradiation using 40 Gy /10 fractions | Radiation | 40 Gy-10 Treatments, 5 Treatment days |
|
|
Rate of moderate to severe breast fibrosis determined by number of patients who developed moderate to severe breast fibrosis after partial breast irradiation according to radiation dose level |
| 8 years |
| Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation | Number of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes. | 8 years |
| To Evaluate Patient Satisfaction | A survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance. | 8 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States |
| Derived |
| Recht A, Ancukiewicz M, Alm El-Din MA, Lu XQ, Martin C, Berman SM, Hirsch AE, Kachnic LA, Katz A, MacDonald S, Nedea EA, Stevenson MA, Powell SN, Taghian AG. Lung dose-volume parameters and the risk of pneumonitis for patients treated with accelerated partial-breast irradiation using three-dimensional conformal radiotherapy. J Clin Oncol. 2009 Aug 20;27(24):3887-93. doi: 10.1200/JCO.2008.20.0121. Epub 2009 Jul 20. |
| FG001 | Irradiation Using 36 Gy / 9 Fractions | Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days |
| FG002 | Irradiation Using 40 Gy / 10 Fractions | Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions, BID: 4 Treatment Days, within 1 week |
| BG001 | Group 2 | Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions, BID: 4 1/2 Treatment Days, within 1 week |
| BG002 | Group 3 | Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions, BID: 5 Treatment Days, within 1 week |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
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| Number of patients with triple negative cancer (ER-/PR-/HER2-) | Number of patients with ER-/PR-/HER2- cancer. | 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 | Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion. | Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility. | Posted | Count of Participants | Participants | 10 years |
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| Primary | Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy | Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy | Posted | Count of Participants | Participants | 10 years |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint | Number of patients who presented with moderate to severe composite toxicity as an endpoint | Posted | Count of Participants | Participants | 8 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation | Rate of moderate to severe breast fibrosis determined by number of patients who developed moderate to severe breast fibrosis after partial breast irradiation according to radiation dose level | Posted | Count of Participants | Participants | 8 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation | Number of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes. | Posted | Count of Participants | Participants | 8 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate Patient Satisfaction | A survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance. | Posted | Count of Participants | Participants | 8 years |
|
8 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 | Group 1 | Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days | 0 | 98 | 0 | 98 | 0 | 98 |
| EG001 | Group 2 | Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days | 0 | 99 | 0 | 99 | 0 | 99 |
| EG002 | Group 3 | Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week Partial Breast Irradiation using 32 Gy / 8 fractions: 32 Gy-8 Treatments, 4 Treatment Days Partial Breast Irradiation using 36 Gy / 9 fractions: 36 Gy- 9 Treatments, 4 1/2 Treatment Days Partial Breast Irradiation using 40 Gy /10 fractions: 40 Gy-10 Treatments, 5 Treatment days | 0 | 124 | 0 | 124 | 0 | 124 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alphonse Taghian | Massachusetts General Hospital | 6177261160 | ataghian@mgh.harvard.edu |
| Sep 8, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2009 | Sep 8, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D018270 | Carcinoma, Ductal, Breast |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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