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The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Radiotherapy | Experimental | Two week course of proton radiotherapy to the breast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiation therapy | Radiation | Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse. |
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral Breast Tumor Recurrence-free Survival | Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam | Up to 5 years post-treatment completion, average of 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival rate at 5 years post-treatment completion. | Up to 5 years post- completion of treatment, average 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A. Bush, MD | Loma Linda University Department of Radiation Medicine | Principal Investigator |
| Jerry D. Slater, MD | Loma Linda University Department of Radiation Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St. | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17476139 | Result | Bush DA, Slater JD, Garberoglio C, Yuh G, Hocko JM, Slater JM. A technique of partial breast irradiation utilizing proton beam radiotherapy: comparison with conformal x-ray therapy. Cancer J. 2007 Mar-Apr;13(2):114-8. doi: 10.1097/PPO.0b013e318046354b. | |
| 21729673 | Result | Bush DA, Slater JD, Garberoglio C, Do S, Lum S, Slater JM. Partial breast irradiation delivered with proton beam: results of a phase II trial. Clin Breast Cancer. 2011 Aug;11(4):241-5. doi: 10.1016/j.clbc.2011.03.023. Epub 2011 Jun 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Radiotherapy | Two week course of proton radiotherapy to the breast. Proton radiation therapy: Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Females with invasive nonlobular carcinoma greater or less than 3 cm
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| ID | Title | Description |
|---|---|---|
| BG000 | Partial Breast Radiotherapy With Proton Beam | Two weeks of proton beam radiotherapy to the lumpectomy site |
| 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 | Ipsilateral Breast Tumor Recurrence-free Survival | Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam | Posted | Number | 95% Confidence Interval | percentage of patients | Up to 5 years post-treatment completion, average of 48 months |
|
|
Change between baseline pre-treatment and 5 years post-treatment completion.
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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 | Proton Radiotherapy | Two week course of proton radiotherapy to the breast. Proton radiation therapy: Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distant metatastatic disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bush, MD, Vice Chair Clinical Affairs Radiation Medicine | Loma Linda University Health | 909 558 1000 | DBush@llu.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 | Apr 8, 2008 | Aug 3, 2023 | 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 |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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| 25084608 | Result | Bush DA, Do S, Lum S, Garberoglio C, Mirshahidi H, Patyal B, Grove R, Slater JD. Partial breast radiation therapy with proton beam: 5-year results with cosmetic outcomes. Int J Radiat Oncol Biol Phys. 2014 Nov 1;90(3):501-5. doi: 10.1016/j.ijrobp.2014.05.1308. Epub 2014 Jul 30. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Involved Breast | Count of Participants | Participants |
|
| Tumor Size (cm) | Mean | Full Range | CM |
|
| ER Receptor Status | Count of Participants | Participants |
|
|
| Secondary | Overall Survival | Overall survival rate at 5 years post-treatment completion. | Posted | Number | 95% Confidence Interval | % Alive | Up to 5 years post- completion of treatment, average 48 months |
|
|
|
| 2 |
| 50 |
| 49 |
| 50 |
| 0 |
| 50 |
| Isolated axillary occurence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Events Leading to Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Metastatic Breast Cancer |
|
| Esopageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Grade 1 - 2 Acute Skin Toxicity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Telangiectasia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |