Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer

Inclusion Criteria

Only women who satisfy all of the following conditions will be eligible for this study.

• must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
• must be at least 21 years old
• must have stage 0, I, or II breast cancer
• On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast.
• Surgical treatment of the breast must have been breast conserving surgery (BCS). The margins of the resected specimen must be histologically free of tumor (including DCIS component). Reexcision of surgical margins is permitted.
• Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins.
• Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.
• must begin adjuvant therapy (chemotherapy or radiotherapy) within 9 weeks following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure)
• Patients must have all usual and customary hormone receptor (ER/PR) and estrogen receptor (ER) analysis performed on the primary tumor prior to enrollment. Patients with invasive disease must have HER2 receptor status determined (positive or negative) with immuno-histochemistry (IHC) and/or fluorescent in-situ hybridization (FISH).
• At the time of study enrollment, patients must have had a history & physical exam within 4 months and a bilateral mammogram within 6 months.
• Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• Patients must live in a county that is designated as Appalachian and/or rural by Kentucky Cancer Registry Criteria (see list below) and/or must hold their primary residence at least 10 miles from the nearest radiation facility. Patients who do not fit these criteria may still be considered eligible if they are determined to suffer significant financial and/or transportation hardship during a typical course of CF-RT or HF-RT (in the judgment of any of their treating physicians). Patients who live outside the Commonwealth of Kentucky are eligible if they fit any of these aforementioned conditions.
• Appalachian counties in KY include: Adair, Bath, Bell, Boyd, Breathitt, Carter, Casey, Clark, Clay, Clinton, Cumberland, Edmonson, Elliott, Estill, Fleming, Floyd, Garrard, Green, Greenup, Harlan, Hart, Jackson, Johnson, Knott, Knox, Laurel, Lawrence, Lee, Leslie, Letcher, Lewis, Lincoln, Madison, Magoffin, Martin, McCreary, Menifee, Metcalfe, Monroe, Montgomery, Morgan, Nicholas, Owsley, Perry, Pike, Powell, Pulaski, Robertson, Rockcastle, Rowan, Russell, Wayne, Whitley, Wolfe.

Exclusion Criteria

Men are not eligible for this study. Women with one or more of the following conditions are ineligible for this study.

• T3, stage III, or stage IV breast cancer
• More than 3 histologically positive axillary nodes
• Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
• One or more positive non-axillary sentinel node(s) (Note that intramammary nodes are staged as axillary nodes.)
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, o