Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen (NCT05591547) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen
United States91 participantsStarted 2022-03-30
Plain-language 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.
Who can participate
Age range50 Years
SexFEMALE
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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.
* Absence of lymphovascular space invasion.
* The tumor must be positive for either the presence of the estrogen or progesterone receptor, and either 0 or +1 for the HER-2/neu receptor on immunohisto…