SH APBI RISE: Evaluating the Safety and Efficacy of a Novel IMRT/VMAT-based Accelerated Partial Breast Irradiation Regimen for PatIents with Favorable Risk BreaSt CancEr
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Sanford Health
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Physician-Assessed Adverse Breast Cosmesis
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.
Detailed Description
This is a prospective observational cohort study in breast cancer participants. The purpose of this study is to report physician-assessed cosmetic outcomes.
Investigators
Ryan K Nowak, MD
Principal Investigator
Sanford Health
Eligibility Criteria
Inclusion Criteria
- •Ability to provide informed written consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 or a Karnofsky performance score of ≥ 30%.
- •Willingness to return to Sanford Cancer Center for follow-up.
- •Radiation therapy is planned as part of routine care.
- •On histological examination, the tumor must be either ductal carcinoma in-situ (DCIS) or an invasive ductal carcinoma of the breast.
- •Patients must be ≥ 50 years old.
- •Presence of unifocal tumor.
- •Surgical treatment of the breast must have been a lumpectomy. Placement of surgical clips to delineate the lumpectomy bed is highly recommended, though not required.
- •The final margins of the resected specimen must be histologically free of tumor (≥ 2 mm for invasive adenocarcinoma and ≥ 3 mm for DCIS). Re-excision of surgical margins is permitted. Gross disease must be unifocal with a pathologic invasive tumor size tumor size ≤ 2.0 cm or pathologic DCIS size ≤ 2.5 cm.
- •Patients with invasive breast cancer are required to have axillary staging consisting of a sentinel lymph node biopsy. The sentinel lymph node(s) must be negative for regionally metastatic disease, both on routine H\&E evaluation and immunohistochemical staining. Axillary staging is not required for patients with DCIS.
Exclusion Criteria
- •Pregnant women, or women of childbearing potential who are unwilling to employ adequate contraception.
- •Nuclear grade 3 DCIS or Nottingham grade 3 invasive ductal carcinoma.
- •Invasive lobular carcinoma, any grade.
- •Male sex.
- •Any treatment with radiation therapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study enrollment
- •Prior breast or thoracic radiation treatment for any reason.
- •History of prior invasive breast cancer or DCIS. (Patients with a history of LCIS treated by surgery alone are eligible.)
- •Paget's disease of the nipple.
- •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.
- •Patients with a collagen vascular disease; specifically, SLE or scleroderma.
Outcomes
Primary Outcomes
Physician-Assessed Adverse Breast Cosmesis
Time Frame: 2 Years
To evaluate the incidence of physician-assessed adverse breast cosmesis by utilizing the Harvard Breast Cosmesis survey. The survey scores breast cosmesis from 1 to 4, with 1 representing "excellent" cosmesis, 2 representing "good" cosmesis, 3 representing "fair" cosmesis, and 4 representing "poor" cosmesis. Adverse breast cosmesis is defined as a score of either 3 or 4 on the Harvard Breast Cosmesis survey.
Secondary Outcomes
- Acute Adverse Events(12 Weeks)
- Recurrence Rate(2 Years)
- Disease Free Survival Rate(2 Years)
- Late Adverse Events(2 Years)
- Patient Quality of Life(2 Years)
- Patient-Assessed Adverse Breast Cosmesis(2 Years)