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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01248 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
Establish the feasibility for preoperative APBI delivered with IMRT in the prone position using daily CT guidance for Stage I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.
SECONDARY OBJECTIVES:
OUTLINE:
Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
After completion of treatment, patients are followed up at 4 weeks and then every 6 months for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (image-guided intensity-modulated APBI) | Experimental | Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| accelerated partial breast irradiation | Radiation | Undergo image-guided intensity-modulated APBI |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method | Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery). | 4-6 weeks post-APBI |
| Measure | Description | Time Frame |
|---|---|---|
| Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0 | Up to 4 weeks post-surgery | |
| Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0 | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sasha Beyer, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Cohort 1 Informed Consent | Jul 16, 2025 |
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| intensity-modulated radiation therapy | Radiation | Undergo image-guided intensity-modulated APBI |
|
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| image-guided radiation therapy | Radiation | Undergo image-guided intensity-modulated APBI |
|
| therapeutic conventional surgery | Procedure | Lumpectomy |
|
| Cosmetic outcome by the physician and patient | At year 1 |
| Cosmetic outcome by the physician and patient | At year 3 |
| In-breast recurrence | Up to 5 years |
| Regional recurrence | Up to 5 years |
| Distant metastases | Up to 5 years |
| Disease free survival | Up to 5 years |
| Overall survival | Up to 5 years |
| Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs | Correlative analyses | Up to 4 weeks post-surgery |
| Sep 8, 2025 |
| ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Cohort 2 Informed Consent | Jul 16, 2025 | Sep 8, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D018270 | Carcinoma, Ductal, Breast |
| D001943 | Breast Neoplasms |
| 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 |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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