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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
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Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed").
The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients.
The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.
After signing the consent form, the following will be assessed.
-CT scan of the breast that had the cancer removed to help plan the radiation therapy. This is referred to as a CT-simulation. This scan is done routinely as part of the regular treatment.
PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over a 2 week period. During this time you will have a weekly interview, physical examination, and your skin will be assessed for any side effects of the radiation.
PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after chemotherapy (if you have been given chemotherapy).
After the final dose of the study:
You will have the following scheduled follow-up visits: one at the completion of the radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6 months for five years, and then once every year for the following five years after the completion of radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Breast Irradiation | Experimental | Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Beam Partial-Breast Irradiation | Radiation | 40 Gy in ten daily fractions over two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks | The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.
The data is shown as the number of participants that experienced each of the specific toxicities. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rates | The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Isreal Deaconness Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Brigham and Women's Hosptial |
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| ID | Title | Description |
|---|---|---|
| FG000 | Partial Breast Irradiation | Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Partial Breast Irradiation | Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks | The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.
The data is shown as the number of participants that experienced each of the specific toxicities. | Analysis does not include the one participant who withdrew consent before outcome was met. | Posted | Count of Participants | Participants | 2 years |
|
Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis.
The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
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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 | Partial Breast Irradiation | Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Cellulitis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alphonse Taghian, MD, PhD | Massachusetts General Hospital | 617-726-7559 | ATAGHIAN@mgh.harvard.edu |
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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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| 2 years |
| Distant Control Rates | The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain. | 2 years |
| Breast Cosmesis | Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.
| End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| Participants |
|
| Age, Continuous | Median | Full Range | 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 | Count of Participants | Participants |
|
| Method of Initial Diagnosis | The participant that withdrew consent was not included in the analysis | Count of Participants | Participants |
|
| Side of the breast cancer | Participant that withdrew consent was not included | Count of Participants | Participants |
|
| Stage | Breast Cancer Staging:
| Participant that withdrew consent was not included | Count of Participants | Participants |
|
| T staging | T staging uses T plus a number (0 to 4) to describe the size and location of the tumor
| Participant that withdrew consent is not included | Count of Participants | Participants |
|
| Her2 FISH | FISH (Fluorescence In Situ Hybridization) test for expression of Her2 (human epidermal growth factor receptor 2). Positive results indicate that Her2 is being expressed while negative indicates that Her2 is not expressed. | The participant that withdrew consent was not included in the analysis | Count of Participants | Participants |
|
| Her2 IHC | Immunohistochemistry (IHC) test to show if the tumor cells have Her2 receptors on their surface. IHC test gives a score from 0 to 3+ that measures the amount of Her2 receptor protein on the surface of the cancer cells. A score of either 0 or 1+ is considered Her2 negative, a score of 2+ is considered borderline, a score of 3+ is considered positive. The positive result means that the cells are expressing the Her2 protein. | The participant that withdrew consent was not included in the analysis | Count of Participants | Participants |
|
| Estrogen Receptor | Test whether the cancer cells express estrogen receptors.
| The participant that withdrew consent was not included in the analysis | Count of Participants | Participants |
|
| Progesterone Receptor | Test for the presence of Progesterone receptors on the cancer cells. Positive indicates that they are present, Few/ faint cells indicates a borderline result, negative indicates they were not detected. | The participant that withdrew consent was not included in the analysis | Count of Participants | Participants |
|
| Histologic Grade | Differentiation refers to how similar cancer tissue is to normal tissue. Well differentiated cancer tissue looks more like normal tissue and tends to grow or spread more slowly than poorly differentiated cancer tissue which looks less like normal tissue. | The participant that withdrew consent was not include in the analysis | Count of Participants | Participants |
|
Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks
External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks
|
|
| Secondary | Local Control Rates | The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'. | The one participant that withdrew consent before the outcome was met was excluded from the analysis | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Distant Control Rates | The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain. | The one participant that withdrew consent before the outcome was met was excluded from the analysis | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Breast Cosmesis | Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.
| The one participant that withdrew consent before outcomes were met was excluded from the analysis. | Posted | Count of Participants | Participants | End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years |
|
|
|
| 0 |
| 53 |
| 2 |
| 53 |
| 47 |
| 53 |
|
| Seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|
|
| Poor |
|