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| ID | Type | Description | Link |
|---|---|---|---|
| UPCC-08104 | |||
| UPCC-IRB-801897 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.
OBJECTIVES:
OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).
After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APBI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant therapy | Procedure |
| ||
| conventional surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up | 11 months | |
| Site of disease recurrence (i.e., local, regional, or distant) | 11 months |
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DISEASE CHARACTERISTICS:
Women who have chosen to undergo breast conservation therapy, including lumpectomy and breast irradiation, at the University of Pennsylvania for any invasive mammary carcinoma or intraductal breast cancer
Stage I-II invasive or intraductal breast cancer
Unifocal tumor ≤ 3.0 cm in size
No proven multicentric carcinoma in more than 1 quadrant or separated by 4 or more centimeters
Negative margins of excision (≥ 2 mm) OR no tumor seen in a re-excision specimen
No extensive intraductal component present
Negative sentinel lymph node (SLN) or axillary lymph node dissection OR fewer than 4 positive nodes on adequate axillary lymph node dissection (i.e., 10 or more lymph nodes removed)
If a SLN is positive on hematoxylin and eosin (but not by immunohistochemistry alone), complete axillary lymph node dissection is required
No SLN identified in the internal mammary nodes
No node > 2 cm
No node with extracapsular extension
Surgical clips placed in the operative bed OR ability to visualize operative bed on CT scan of the breast
No diffuse calcifications on diagnostic mammogram
Hormone receptor status unspecified
PATIENT CHARACTERISTICS:
Female
Menopausal status not specified
History of non-breast malignancies allowed provided patients have been disease free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence
Patients must agree to undergo breast MRI
No contraindication to MRI, including a pacemaker or other foreign body
Not pregnant or nursing
No technical impediment to appropriate dosimetry
No personal history of collagen vascular disease
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Lilie Lin, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
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| 3-dimensional conformal radiation therapy | Radiation |
|
| brachytherapy | Radiation |
|
| intracavitary balloon brachytherapy | Radiation |
|
| proton beam radiation therapy | Radiation |
|
| Time to recurrence | 11 months |
| Time to locoregional recurrence | 11 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018275 | Carcinoma, Lobular |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D002278 | Carcinoma in Situ |
| D044584 | Carcinoma, Ductal |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D020266 | Radiotherapy, Conformal |
| D001918 | Brachytherapy |
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D063193 | Heavy Ion Radiotherapy |
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