A Phase II Study of Accelerated Hypofractionated Radiotherapy (AHF-RT) After Breast Conserving Surgery (BCS) in Medically Underserved Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Louisville
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Ipsilateral Breast Tumor Recurrence (IBTR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this study is to explore the safety, effectiveness, quality of life, and cost effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after lumpectomy in patients with early stage breast cancer.
Detailed Description
The traditional radiation treatment schedule for patients who have had a lumpectomy for early stage breast cancer is 15 to 30 treatments delivered once a day for 3 to 6 weeks. This treatment schedule can be inconvenient and costly for elderly, rural, uninsured, and minority patients. This study will evaluate a new radiation treatment schedule called whole-breast accelerated hypofractionated radiotherapy (AHF-RT). AHF-RT delivers higher doses of radiation in fewer treatments than traditional radiation therapy. The AHF-RT treatment course is completed with 5 radiation treatments delivered once a week for 5 weeks. The purpose of this study is to determine if accelerated hypofractionated radiotherapy (AHF-RT) is a safe, effective, more convenient, and less costly alternative to traditional radiation that will offer the same chance of cure with no additional side effects.
Investigators
Harriet Eldredge-Hindy
Assistant Professor, M.D.
University of Louisville
Eligibility Criteria
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).
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, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
- •Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
- •Non-epithelial breast malignancies such as sarcoma or lymphoma
- •Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters
- •Paget's disease of the nipple
Outcomes
Primary Outcomes
Ipsilateral Breast Tumor Recurrence (IBTR)
Time Frame: at 5 years post completion of AHF-RT
Both invasive and non-invasive IBTRs will be considered in calculating the primary endpoint.