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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000643276 | Other Identifier | NIH | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| 0220090059 | Other Identifier | IRB | |
| 040807 | Other Identifier | Rutgers Cancer Institute of New Jersey |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey | OTHER |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.
Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.
After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI) |
|
| B | Active Comparator | Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External beam boost | Radiation | 3-dimensional conformal radiation therapy and intensity modulated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loco-regional control as assessed by physical examination, mammography, and other relevant imaging | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0 | 5 years | |
| Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale | 5 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer, including 1 of the following subtypes:
Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)
Breast considered technically satisfactory for radiotherapy
Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
Unifocal or multifocal (confined to 1 quadrant; tumors < 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy
No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
No evidence of suspicious microcalcifications in the breast before the start of radiotherapy
No more than 9 positive axillary lymph nodes
No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
No Paget disease of the nipple
No skin involvement, regardless of tumor size
No distant metastases
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior radiotherapy for the current breast cancer
No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy
Chemotherapy allowed provided the following criteria are met:
Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed
No other concurrent chemotherapy, immunotherapy, or experimental medications
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Haffty, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RWJBarnabas Health - Robert Wood Johnson University Hospital | Hamilton | New Jersey | 08690 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40836156 | Derived | Chakraborty MA, Sherwani ZK, Narra LR, Abou Yehia Z, Ohri N, Cui T, Eladoumikdachi F, Kowzun MJ, Kumar S, Potdevin L, Toppmeyer DL, Haffty BG. Preoperative Radiation Boost Results in Low Rates of Re-excision and Reduced Locoregional Treatment Time in Breast Cancer Patients. Ann Surg Oncol. 2025 Dec;32(13):9836-9842. doi: 10.1245/s10434-025-18089-9. Epub 2025 Aug 20. | |
| 26700706 | Derived | Ahlawat S, Haffty BG, Goyal S, Kearney T, Kirstein L, Chen C, Moore DF, Khan AJ. Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):118-125. doi: 10.1016/j.ijrobp.2015.09.011. Epub 2015 Sep 16. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| whole breast irradiation | Radiation | accelerated, hypofractionated whole breast irradiation |
|
| RWJBarnabas Health - Robert Wood Johnson University Hospital |
| New Brunswick |
| New Jersey |
| 08690 |
| United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| RWJBarnabas Health - Robert Wood Johnson University Hospital | Somerset | New Jersey | 08873 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |